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Conservative management following closed reduction of traumatic anterior dislocation of the shoulder

  1. Nigel CA Hanchard1,*,
  2. Lorna M Goodchild2,
  3. Lucksy Kottam3

Editorial Group: Cochrane Bone, Joint and Muscle Trauma Group

Published Online: 30 APR 2014

Assessed as up-to-date: 1 MAR 2014

DOI: 10.1002/14651858.CD004962.pub3


How to Cite

Hanchard NCA, Goodchild LM, Kottam L. Conservative management following closed reduction of traumatic anterior dislocation of the shoulder. Cochrane Database of Systematic Reviews 2014, Issue 4. Art. No.: CD004962. DOI: 10.1002/14651858.CD004962.pub3.

Author Information

  1. 1

    Teesside University, Health and Social Care Institute, Middlesbrough, Tees Valley, UK

  2. 2

    The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Department of Physiotherapy, Middlesbrough, Tees Valley, UK

  3. 3

    The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Department of Orthopaedics, Middlesbrough, UK

*Nigel CA Hanchard, Health and Social Care Institute, Teesside University, Middlesbrough, Tees Valley, TS1 3BA, UK. n.hanchard@tees.ac.uk.

Publication History

  1. Publication Status: New search for studies and content updated (conclusions changed)
  2. Published Online: 30 APR 2014

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Summary of findings    [Explanations]

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

 
Summary of findings for the main comparison. Immobilisation in external rotation compared with immobilisation in internal rotation for traumatic anterior dislocation of the shoulder

Immobilisation in external rotation compared with immobilisation in internal rotation for traumatic anterior dislocation of the shoulder

Patient or population: patients with traumatic anterior dislocation of the shoulder
Settings: splints applied in emergency departments
Intervention: immobilisation in external rotation
Comparison: immobilisation in internal rotation

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No. of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

Immobilisation in internal rotationImmobilisation in external rotation

Re-dislocation, with two-year or longer follow-up
Verified self-report in Liavaag 2011. Mechanism of data collection unclear in Finestone 2009 and Taskoparan 2010
Follow up: 24 to 48 months1
Low-risk populationRR 1.06
(0.73 to 1.54)
252
(3 studies)
⊕⊝⊝⊝
very low2,3
Assumed low risk based on Liavaag 2011. Assumed medium risk based on the median of Finestone 2009 and Taskoparan 2010

247 per 1000262 per 1000
(180 to 380)

Medium-risk population

436 per 1000462 per 1000
(318 to 671)

Validated participant-reported outcome measures for shoulder instability
Western Ontario Shoulder Instability Index (WOSI). Scale from 0 to 2100
See commentSee commentNot estimable174
(1)
See commentOnly non-parametric data: quality of evidence not computable. Result reportedly non-significant

Resumption of sport at any level, with two-year or longer follow-up
Direct examination or telephone interview
Follow-up: mean 25.6 months
Medium-risk populationRR 1.13
(0.87 to 1.48)
109
(1 study)
⊕⊝⊝⊝
very low4,5
Assumed risk based on single study reporting this outcome

633 per 1000715 per 1000
(551 to 937)

Resumption of sport/activities, with two-year or longer follow-up
Direct examination, telephone interview (Itoi 2007) or postal questionnaire (Liavaag 2011)
Follow-up: 24 to 54 months
Low-risk populationRR 1.25
(0.71 to 2.2)
278
(2 studies)
⊕⊝⊝⊝
very low5,6,7
Assumed low risk based on Itoi 2007. Assumed high risk based on Liavaag 2011

204 per 1000255 per 1000
(145 to 449)

High-risk population

605 per 1000756 per 1000
(429 to 1000)

Participant satisfaction with the intervention—not reportedSee commentSee commentNot estimable-See commentNo study reported this outcome

Any instability (subluxation or re-dislocation), with two-year or longer follow-up
Direct examination, telephone interview (Itoi 2007) or questionnaire (Liavaag 2011)
Follow-up: 24 to 54 months8
Medium-risk populationRR 0.82
(0.5 to 1.33)
322
(2 studies)
⊕⊝⊝⊝
very low2,3,6,9
Assumed risk based the on median of the two studies reporting this outcome

484 per 1000397 per 1000
(242 to 644)

Important adverse events
Mechanism of data collection unclear
37 per 100023 per 1000
(3 to 165)
RR 0.61
(0.08 to 4.46)
216
(2 studies)
⊕⊝⊝⊝
very low3,6,10,11
Assumed risk based on median of the two studies reporting this outcome

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in the comments. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio.

GRADE Working Group grades of evidence.
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1Based on Finestone (24 to 48 months) and Liavaag (24 months). Follow-up point unspecified in Taskoran 2010.
2Most information is from studies at low or unclear risk of bias.
395% confidence interval around pooled estimate of effect includes (1) no effect, (2) appreciable benefit favouring immobilisation in external rotation and (3) appreciable benefit favouring immobilisation in internal rotation.
4High risk of bias for one or more key domains.
595% confidence interval around pooled estimate of effect includes (1) no effect and (2) appreciable benefit favouring immobilisation in external rotation.
6The proportion of information from studies at high risk of bias is sufficient to affect the interpretation of results.
7Chi2 was statistically significant at P value 0.09, and the I2 statistic was 65% ("which may represent substantial heterogeneity").
8Mean 25.6 months (Itoi 2007) and 29.1 months (Liavaag 2011).
9Chi2 was statistically significant at P value 0.06, and the I2 statistic was 72% ("which may represent substantial heterogeneity").
10Data on adverse events were gathered ad hoc, and it is unclear whether all such events would have been captured by this strategy.
11Reporting of this outcome was ad hoc and possibly was not comprehensive.

 

Background

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
 

Description of the condition

Dislocation of the shoulder occurs when the head of the humerus (the top end of the upper arm bone) is displaced out of the glenohumeral (shoulder) joint. The extent of dislocation varies from subluxation (partial dislocation) to full dislocation (where the joint surfaces completely lose contact). It is usually diagnosed by a combination of history, physical examination findings and imaging - most often radiography (x-ray), but more rarely some other imaging modality such as magnetic resonance imaging (MRI). The direction of dislocation varies, but in most primary (first-time) dislocations, the head of the humerus (the top of the upper arm bone that forms the ball of the shoulder joint) is displaced anteriorly (forwards) in relation to the glenoid fossa (the socket of the shoulder joint). The cause is usually trauma, typically during contact sports in adolescents and younger adults. In older adults, dislocation may result from a fall from standing height. Traumatic anterior dislocation accounts for 96% of all shoulder dislocations (Goss 1988).

A study based in the USA (Simonet 1984) found an overall adjusted incidence of initial traumatic shoulder dislocation of 8.2 per 100,000 person-years, and estimated the incidence of all traumatic shoulder dislocations - initial and recurrent - to be at least 11.2 per 100,000 person-years. Simonet 1984 was a relatively small epidemiological study that was limited to a single rural county. More recently, Zacchilli 2010 examined the incidence of traumatic shoulder dislocation in the whole USA population and reported that the overall adjusted incidence is more than twice as high as was previously believed (23.9, 95% confidence interval (CI) 20.8 to 27.0, per 100,000 person-years). Seventy-eight per cent of dislocations occur in men (overall incidence rate in males: 34.9 per 100,000 person-years, 95% CI 30.1 to 39.7; in females: 13.3 per 100,000 person-years, 95% CI 11.6 to 15.0) (Zacchilli 2010). Although shoulder dislocation is generally considered an injury of young adults, Rowe 1956 found that there were as many initial dislocations after age 45 as before age 45. Twenty per cent of 545 consecutive patients presenting with anterior shoulder dislocation were 60 years of age or older in Gumina 1997. Zacchilli 2010 found a bimodal age distribution with peaks in the third decade (corresponding to the peak male incidence) and the ninth decade (corresponding to the peak female incidence). This is broadly consistent with the results of another study, based in Sweden (Hovelius 1982), which found that 35 (1.7%) of 2092 randomly selected people 18 to 70 years of age had experienced shoulder dislocation. Although the overall male-to-female ratio was three to one, the ratio was nine to one in the 21 to 30 year age group and, conversely, one to three in the 50 to 70 year age group.

Once dislocation has occurred, the shoulder is less stable and is more susceptible to re-dislocation. Recurrent dislocation tends to be more common in younger adults. For instance, a 10-year follow-up evaluation found that 66% of those between 12 and 22 years of age at the time of their first dislocation had one or more recurrences, whereas this occurred in 24% of those between 30 and 40 years of age (Hovelius 1996). Gumina 1997 found single or multiple recurrences in 22% of those 60 years of age or older.

The nature and extent of damage to the soft tissue surrounding the shoulder joint from a traumatic anterior dislocation vary. Common presentations include the Bankart lesion, characterised by damage to the anteroinferior part of the glenoid labrum (the fibrocartilage rim that deepens the joint socket) and the capsule surrounding the joint (Bankart 1938), and the Hill-Sachs lesion, which involves a compression fracture of the humeral head, as well as damage to its overlying cartilage (Hill 1940).

 

Description of the intervention

Traditionally, a non-surgical (conservative) approach, comprising closed reduction, three to six weeks' immobilisation in a sling and a subsequent physiotherapy or physical therapy programme (O'Brien 1987), has been used for first time dislocations. Recent years have seen much interest in an alternative to the traditional immobilisation method, whereby the shoulder is immobilised in external (outward) rotation using a custom-made (Itoi 2003) or commercially manufactured (Sullivan 2007) splint.

Surgical intervention has generally been reserved for cases of chronic recurrence/instability. However, a Cochrane review (Handoll 2004; updated in 2009) comparing surgical with non-surgical treatment found some limited evidence supporting primary surgery for young adults, usually male, engaged in highly demanding physical activities who have sustained their first acute traumatic shoulder dislocation.

Our review considers the various approaches to post-reduction conservative treatment, such as the duration and position of sling immobilisation, the modalities used, and the timing and extent of rehabilitation interventions.

 

How the intervention might work

The aim of treatment for anterior dislocation is to restore a functional, painless and stable shoulder. The choice of treatment approach will be influenced by patient age and previous history of dislocation, occupation, level of activity, general health and ligamentous laxity and by expectations of patient adherence to a prescribed therapeutic regimen.

The aim of immobilisation is to allow healing. In this connection, some MRI and cadaveric studies of Bankart lesions (Dymond 2011; Itoi 2001; Kitamura 2005; Liavaag 2009; Miller 2004; Moxon 2010; Pennekamp 2006; Seybold 2009; Siegler 2010) have shown better and firmer repositioning of the peeled-away capsule when the shoulder is externally rotated than when it is internally (inwardly) rotated - the position naturally imposed by a sling. This has kindled and sustained interest in the possibility that external rotation immobilisation may improve healing, and consequently outcomes, in comparison with the traditional approach. However any immobilisation has potential disadvantages, and there is an argument for shortening its duration (Kiviluoto 1980) or forgoing it altogether (Hovelius 2008) to allow early restoration of movement, especially in the middle-aged to elderly, who are susceptible to immobilisational stiffness and frozen shoulder (Robinson 2012) but are less prone to re-dislocation than the young (Hovelius 1996).

Finally, various exercise interventions might theoretically increase functional stability by restoring shoulder joint proprioception (spatial awareness) in the shoulder joint and by retraining muscles to help maintain joint congruency (Karatsolis 2006); while motion-limiting braces might prevent re-dislocation by restricting shoulder movement in vulnerable directions (Murray 2013).

 

Why it is important to do this review

This is an update of a Cochrane review published in 2006 (Handoll 2006). Handoll 2006 included only preliminary data from one flawed, partly quasi-randomised trial (Itoi 2003), which compared the immobilisation positions of external and internal rotation and found no difference in terms of return to sport, re-dislocation or instability. Since then, there has been a proliferation of studies (laboratory-based (Limpisvasti 2008; Miller 2004), observational (Dymond 2011; Kitamura 2005; Moxon 2010; Pennekamp 2006; Seybold 2009; Siegler 2010) and RCTs (such as Finestone 2009; Liavaag 2011; Taskoparan 2010)) evaluating immobilisation in external rotation; there are also a number of registered trials. Questions surround other aspects of immobilisation as well (timing of application and duration, position and whether any immobilisation is better than none at all), rehabilitation (its general effectiveness, its relative effectiveness across different settings and the relative effectiveness of different packages and modes of delivery) and motion-limiting braces. These considerations illustrate the need for an updated review.

 

Objectives

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

To assess the effects (benefits and harms) of conservative interventions after closed reduction of traumatic anterior dislocation of the shoulder. These might include immobilisation, rehabilitative interventions or both.

 

Methods

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
 

Criteria for considering studies for this review

 

Types of studies

We considered any randomised or quasi-randomised (e.g. allocation by hospital record number or date of birth) controlled trials evaluating conservative treatment after anterior dislocation of the shoulder.

 

Types of participants

Individuals who have undergone closed reduction for traumatic anterior dislocation of the shoulder. Ideally, the acute anterior shoulder dislocation should have been confirmed by physical examination and radiography or another imaging modality such as MRI. We intended to consider the potential for misdiagnosis, such as a missed proximal humeral fracture, in trials in which the method of diagnosis was unspecified or in which diagnosis was based on physical examination alone.

Although we stated that we would include individuals of any age, we correctly anticipated finding no trials focused specifically on the management of traumatic anterior dislocation in children.

We excluded or would have excluded trials focusing on the treatment of participants with non-traumatic or habitual dislocations, or concomitant fractures or multiple trauma; and those focusing on management of neurovascular complications or postsurgical management. We stipulated that trials with mixed populations involving any one indication of the above would be considered for inclusion if the proportion of the latter (e.g. atraumatic dislocation) was clearly defined for each treatment group and was clearly small (< 10%), or if separate data for acute traumatic anterior dislocation were provided.

 

Types of interventions

We planned the following.

  1. To assess whether a difference exists between outcomes of different methods (including arm position) and durations (including none or intermittent) of postreduction immobilisation. However, we planned to exclude trials comparing variants (e.g. duration, position) or supplements to particular immobilisation techniques unless the general effectiveness of the method had been established.
  2. To assess whether a difference exists between outcomes of the provision of rehabilitation intervention (of any kind) versus no intervention. Examples of rehabilitation interventions include advice and education, active and passive mobilisation, proprioception and stabilisation exercises, scapular setting and trunk stability exercises. These may be used in combination or individually and may be applied in various ways and settings. Although these interventions are potentially available to all patients allocated the rehabilitation intervention, their actual application may vary according to the perceived needs of individual patients. We aimed to assess this separately for the provision of any rehabilitation (a) during immobilisation, and (b) after immobilisation.
  3. To assess whether a difference exists between outcomes of different types of rehabilitation interventions. Comparisons would have included different single modalities or different combinations of rehabilitation modalities. However, we planned to exclude trials comparing different techniques, timing (duration, frequency) and intensity of single rehabilitation modalities until the effectiveness of the modality itself had been established. We also would have excluded trials evaluating pharmacological interventions and trials testing interventions aimed solely at pain relief.
  4. To assess whether a difference exists between outcomes of different methods of delivering/providing various rehabilitation interventions. Comparisons would have included supervised therapy versus home exercises, different methods of supervised therapy (e.g. individual versus group instruction) and differences in the frequency and duration of rehabilitation. In the first instance, we did not plan to include comparisons of rehabilitation intervention delivered by individual professionals (e.g. doctors, physiotherapists, occupational therapists) with different levels or backgrounds of expertise or training.

 

Types of outcome measures

 

Primary outcomes

We sought the following outcome measures, which we prespecified as primary.

  1. Re-dislocation: separation of the joint requiring reduction and, ideally, verified
  2. Validated patient-reported outcome measures (PROMs) for shoulder instability (e.g. Oxford Shoulder Instability Score (Dawson 1999), Western Ontario Shoulder Instability Index (WOSI) (Kirkley 1998))
  3. Resumption of pre-injury activities (yes or no)

 

Secondary outcomes

  1. Participant satisfaction with the intervention
  2. Validated health-related quality of life outcome measures (e.g. EQ-5D (standardised measure of health outcome), Short Form (SF)-36)
  3. Any instability: subluxation (separation of the joint not requiring reduction) or subjective instability, either individually or grouped with dislocation as a composite outcome
  4. Important adverse events (not including re-dislocation or instability) that were plausibly attributable to post reduction management (e.g. persistent pain, frozen shoulder). Other adverse events were to be reported narratively

In addition, we intended to take note of any reports of service utilisation or resource use, for instance, length of hospital stay, outpatient attendance and the provision and nature of physiotherapy; and participants' adherence to their allocated interventions.

 

Timing of outcome measurement

Approximately one-third of re-dislocations occur within three months of the initial dislocation, and a further third between three and 12 months (Rhee 2009). We therefore proposed organising outcomes into the following time frames, with greatest importance attached to long-term reporting.

  1. Short-term: up to and including three months following dislocation
  2. Medium-term: greater than three months and up to and including 12 months following dislocation
  3. Long-term: greater than 12 months following dislocation

 

Search methods for identification of studies

 

Electronic searches

We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (September 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (2013 Issue 8), MEDLINE (1946 to September Week 3 2013), MEDLINE In-Process & Other Non-Indexed Citations (September 2013), EMBASE (1980 to 2013 Week 38), CINAHL (1982 to September 2013), PEDro (Physiotherapy Evidence Database) (1929 to November 2012) and OTseeker (Occupational Therapy Systematic Evaluation of Evidence Database) (inception to November 2012). We also searched the WHO International Clinical Trials Registry Platform (November 2012) and the UK National Research Register (2005, Issue 3, now archived) for ongoing and recently completed trials. We applied no language restrictions.

In MEDLINE (Ovid Web), the subject-specific strategy was combined with the sensitivity-maximising version of the Cochrane Highly Sensitive Search Strategy for identifying randomised trials (Lefebvre 2011) and was modified for use in other databases. Search strategies for CENTRAL, MEDLINE, EMBASE and CINAHL can be found in Appendix 1. Details of the search strategies used previously are published in Handoll 2006.

 

Searching other resources

We checked reference lists of articles. We searched the conference proceedings of the British Elbow and Shoulder Society (2003 to 2012). We handsearched conference proceedings published in the supplements of the Journal of Bone and Joint Surgery - British Volume (now known as The Bone and Joint Journal) (January 2004 to January 2013) and Injury (January 2004 to January 2013).

 

Data collection and analysis

 

Selection of studies

Two review authors (LG, LK) independently assessed potentially eligible trials for inclusion, and assessments were checked by a third review author (NH). No disagreement was reported. Titles of journals, names of authors and names of supporting institutions were not masked at any stage.

 

Data extraction and management

All three review authors independently extracted data. The forms were piloted on an excluded study, and discrepancies were resolved through discussion.

 

Assessment of risk of bias in included studies

Risk of bias was independently assessed, without masking of the source and authorship of trial reports, by all three review authors. The assessment form was piloted on one trial. Between rater consistency in assessment was checked by one review author (NH) at data entry. All differences were resolved by discussion. We used the tool outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). This tool incorporates assessment of randomisation (sequence generation and allocation concealment), blinding (of participants and of treatment providers), blinding of outcome assessment, completeness of outcome data, selection of outcomes reported and other sources of bias. Considered among the latter were discrepancies in the level of skill or care with which compared interventions were applied (performance bias) and commercial sponsorship (because of the potential for reporting bias). In future updates, we may consider subjective outcomes (e.g. PROMs) and objective outcomes (re-dislocation) separately in our assessment of blinding of outcome assessment and completeness of outcome data.

 

Measures of treatment effect

When available and appropriate, quantitative data for outcomes listed in the inclusion criteria are presented graphically. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated for dichotomous outcomes. Had continuous data been available, we planned to calculate mean differences (MDs) and 95% CIs calculated for continuous outcomes.

 

Unit of analysis issues

We considered unit of analysis issues very unlikely but nonetheless were alert to the possibility of these in the included studies. None were identified.

 

Dealing with missing data

We approached study authors for missing data by email or, if no email address was available, by post. Email and postal return addresses were given. If answers to more than a few questions were requested, we provided a pro forma to ensure clarity and to minimise the burden on trial authors. To inform our risk of bias judgements of incomplete outcome data, we investigated the effects of missing dichotomous data by conducting worst-case analyses based on assessment of plausible event rates.

 

Assessment of heterogeneity

Heterogeneity between comparable trials was tested using a standard Chi² test and was considered statistically significant at P value < 0.1. When some indication of heterogeneity was noted, from visual inspection of the results or based on results of the Chi² test, we also quantified heterogeneity/inconsistency using the I² statistic (Higgins 2003). This we interpreted as follows: "0 to 40% might not be important"; "30 to 60% may represent moderate heterogeneity"; "50 to 90% may represent substantial heterogeneity"; and "75 to 100% represents considerable heterogeneity" (Section 9.5.2, Higgins 2011).

 

Assessment of reporting biases

In the event that a meta-analysis of a key outcome includes more than 10 studies in a future update, we will consider generating a funnel plot to explore the potential for publication bias.

 

Data synthesis

Results of comparable groups of trials were pooled for meta-analysis using the fixed-effect model and 95% CIs. When heterogeneity was present, we viewed the results of the random-effects model and presented these when appropriate.

 

Subgroup analysis and investigation of heterogeneity

We proposed, if possible, to undertake subgroup analyses by gender, as males are at much greater risk of re-dislocation (Robinson 2006). We also proposed to subgroup by age, using two thresholds: 25 years or younger versus 26 years or older; and 39 years or younger versus 40 years or older. We chose the former threshold because patients aged 25 years or younger are at much greater risk of re-dislocation (Robinson 2006), and the latter because of the markedly increased susceptibility of patients older than 40 years to postimmobilisation stiffness and secondary frozen shoulder (Robinson 2012); these events would be captured by PROMs (one of our primary outcomes) and “other adverse events” (one of our secondary outcomes). To test for differences between subgroups, we intended to inspect the overlap of confidence intervals and to perform the test for subgroup differences available in Review Manager software. We also planned but did not carry out separate outcome analyses of (1) participants who were physically active compared with those who were more sedentary, (2) physically active young adults engaged in highly demanding physical activities who have sustained primary anterior dislocation compared with others, (3) participants with a primary dislocation compared with those with a recurrent dislocation, and (4) participants with a specific lesion resulting from dislocation (e.g. a Bankart lesion) compared with those without. We anticipated that any subgroup differences would be in terms of size of effect (quantitative interaction) rather than direction of effect (qualitative interaction).

 

Sensitivity analysis

When appropriate, we performed sensitivity analyses to investigate various aspects of trial and review methodology. These included, when data were available, examining the effects of (1) removing trials at high risk of selection bias from inadequate allocation concealment or at high risk of detection bias from lack of blinded outcome assessment; (2) conducting worst-case analyses for trials with missing data; and (3) using fixed-effect versus random-effects models for pooling.

 

'Summary of findings' table and quality assessment of the evidence

We produced a 'Summary of findings' table for the only comparison tested so far in the review, and we used the GRADE approach to assess the quality of evidence related to each of the key outcomes listed in the Types of outcome measures (see Section 12.2, Schunemann 2011).

 

Results

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
 

Description of studies

 

Results of the search

Searches were carried out in two stages: August 2005 to October 2012; then October 2012 to September 2013 (see Appendix 1).

For this update, we screened a total of 812 records from the following databases: Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (18 records); Cochrane Central Register of Controlled Trials (58); MEDLINE (145); EMBASE (313); CINAHL (245); PEDro (22); OTseeker (5) and the World Health Organization (WHO) International Clinical Trials Registry Platform (6). We identified one potentially eligible study from handsearches. We reconsidered the nine studies deemed eligible or potentially eligible in the previous version of the review (Handoll 2006). (Results of previous searches, up to September 2005, are shown in Appendix 2.)

We attempted to contact authors of unpublished randomised controlled trials (RCTs) listed in the WHO International Clinical Trials Registry Platform for information on the current status of their respective trials and Kiviluoto 1980 for details of methods. We corresponded with Professor Itoi on his trials (Itoi 2003; Itoi 2007; Itoi 2013), Dr Liavaag on his trial (Liavaag 2011) and Professor Milgrom on his trial (Finestone 2009), and we attempted to contact Drs Miller and Whelan for details of their trials (Miller 2007; Whelan 2008).

In this update, the preliminary report by Itoi 2003 was excluded, although it had been included in the previous version of this review, in favour of the reportedly definitive Itoi 2007. Two newly identified studies were excluded (Chutkan 2012; Whelan 2010), as was Wakefield 2001, which was previously listed as an ongoing study.

Overall, there are now four included studies (Finestone 2009; Itoi 2007; Liavaag 2011; Taskoparan 2010), nine excluded studies (incorporating six carried forward from our previous search), seven studies awaiting classification and three ongoing studies. The results are displayed in a flow chart in Figure 1.

 FigureFigure 1. Study flow diagram

 

Included studies

Full details of the individual studies are given in the Characteristics of included studies tables.

In total, four parallel, two-group RCTs were identified, including 470 participants (371 male), all with primary traumatic anterior dislocation of the shoulder reduced by various closed methods. Two of these studies were relatively large: Itoi 2007 and Liavaag 2011, with 198 and 188 participants, respectively. Finestone 2009 had 51 participants, and Taskoparan 2010 had 33.

Finestone 2009 was conducted in the Accident and Emergency Department of an Israeli university hospital; Itoi 2007, across 12 hospitals in Japan; Liavaag 2011, in 13 Norwegian hospital emergency departments; and Taskoparan 2010, in an emergency department in Turkey. Three studies evaluated mixed populations; in Finestone 2009, all 51 participants were male and 40 of these were soldiers.

All four studies compared post reduction immobilisation of the affected arm in external rotation ( the arm oriented outwards and the forearm away from the chest) versus immobilisation in internal rotation (the traditional sling arrangement, with the forearm rested across the abdomen). There was only minor variation in the degree of external rotation used (reportedly 10 degrees in Itoi 2007 and Taskoparan 2010, 15 degrees in Liavaag 2011 and 15 to 20 degrees in Finestone 2009) and in the duration of immobilisation (whether internal or external rotation) recommended (three weeks by Itoi 2007, Taskoparan 2010 and Liavaag 2011; four weeks by Finestone 2009). Participants were instructed to remove their immobiliser or sling only for showering.

 

Primary outcomes

 
Re-dislocation

Two studies prespecified re-dislocation as an outcome (Finestone 2009; Liavaag 2011). Taskoparan 2010 reported data on re-dislocation but did not prespecify this as an outcome.

 
Validated patient-reported outcome measures for shoulder instability

One study (Liavaag 2011) incorporated a patient-reported outcome measure for shoulder instability, the Western Ontario Shoulder Instability Index (WOSI), although only non-parametric data were reported.

 
Resumption of pre-injury activities (yes or no)

Two studies prespecified return to pre-injury sport or activity as an outcome (Itoi 2007; Liavaag 2011).

 

Secondary outcomes

 
Participant satisfaction with the intervention

None of the included studies incorporated data on participant satisfaction.

 
Validated health-related quality of life outcome measures (e.g. EQ-5D, SF-36)

None of the included studies incorporated generic health-related quality of life outcome data.

 
Any instability: subluxation (separation of the joint not requiring reduction) or subjective instability, either individually or grouped with dislocation as a composite outcome

Itoi 2007 and Liavaag 2011 prespecified re-dislocation or subluxation as a composite outcome, and Liavaag 2011 prespecified subluxation as a stand-alone outcome.

 
Serious adverse events including persistent pain

Although adverse events were mentioned in all of the reports, the trials did not have a priori strategies for defining or collecting these data.

 

Other outcomes

Adherence was the only other outcome collected by more than one of the included studies (Finestone 2009; Itoi 2007; Liavaag 2011).

 

Follow-up time points

Follow-ups were conducted at various time points, but only a two-year (or beyond, i.e. long-term) follow-up was common to Itoi 2007, Finestone 2009 and Liavaag 2011. Taskoparan 2010 did not specify when data were collected on re-dislocation or on adverse events.

 

Excluded studies

Nine studies were excluded, usually as the result of insufficient information and lack of response from study authors (Harper 2000; Kiviluoto 1980; Staply 2002; Wakefield 2001) or failure to meet our selection criteria (Chutkan 2012; Hovelius 1983; Whelan 2010; Xu 2003). Finally, the relationship between Itoi 2003, which was reported as a preliminary study, to Itoi 2007 is unclear, and, reflecting contradictory information received from the trial investigator, we cannot rule out the possibility that there were trial participants in common. Further details of these studies are given in the Characteristics of excluded studies tables.

 

Studies awaiting classification

Seven studies await classification. Of these, six were parallel, two-group RCTs comparing immobilisation in external rotation versus immobilisation in internal rotation: We have identified no published full reports related to any of these, and our efforts to contact the corresponding authors were unsuccessful. ISRCTN41070054 (with an initial target sample size of 50 (revised down to 38)), ISRCTN48254181 with a target sample size of 150 and NCT00707018 with a target sample size of 50 are all completed, according to the WHO International Clinical Trials Registry Platform; and long intervals have passed since the respective anticipated end dates of November 2010, May 2008 and June 2009. Seventy-two participants entered the trial by Kelly 2011, attenuating to 54 at one-year follow-up: Results from a two-year follow-up questionnaire were reported as pending in a 2011 report of the Institute of Orthopaedics (UK). Both Miller 2007 and Whelan 2008 are published abstracts, but neither provides sufficient information to stand alone. Miller 2007 reported interim results for 30 participants, but the total sample aimed for or achieved is unknown. The abstract by Whelan 2008 reported randomisation of 61 participants and only 6.5% loss to follow-up after an average of 18 months. Outcomes of the six studies comparing immobilisation in external rotation versus immobilisation in internal rotation included re-dislocation at one and two years (Kelly 2011) or at unspecified time points (ISRCTN41070054; ISRCTN48254181); patient-reported outcome measures for shoulder instability at one year (Kelly 2011; Miller 2007; NCT00707018) and two years (Kelly 2011; NCT00707018); time taken to resume pre-injury sport or other activities (NCT00707018); difficulties with the immobilisation or rehabilitation protocol at three months (Kelly 2011); disease-specific health-related quality of life data at two years (Whelan 2008); any instability at two years (NCT00707018; Whelan 2008); and participant adherence (Kelly 2011; Whelan 2008).

Also awaiting classification is Itoi 2013. This parallel, three-group RCT is published as a full report but compares supplements to a yet unproven method (immobilisation in external rotation). As such, this trial is not eligible for inclusion at this time.

Further details of these studies are given in the Characteristics of studies awaiting classification tables.

 

Ongoing studies

Three studies, all parallel, two-group RCTs, are ongoing (ACTRN12611001183976; NCT01111500; NCT01648335).

NCT01111500 with a target sample size of 50 and NCT01648335 with an unspecified target sample size are comparing immobilisation in external rotation versus immobilisation in internal rotation. Outcomes include re-dislocation at six months (NCT01648335), one year (NCT01111500) and two years (NCT01111500). The corresponding author of NCT01111500 estimates that her study will be completed in 2014-2015 (personal communication Dr Pelet, 21 January 2013); no corresponding author details are available for NCT01648335, but the entry in ClinicalTrials.gov (accessed through the WHO International Clinical Trials Registry Platform) anticipated an end date of July 2013.

ACTRN12611001183976 is a parallel, two-group RCT with a target sample size of 200 comparing two physiotherapy interventions: strengthening exercises versus pulsed ultrasound and massage, with graduated range of motion exercises common to both groups, after immobilisation in external rotation. The outcome measures are re-dislocation and patient reported outcome measures at six weeks, three months, one year and two years after first-time dislocation. Recruitment is slow, and in a personal communication on 13 November 2012, the corresponding author estimated that completion would take a further 10 years. Because the study is evaluating a supplement to a yet unproven intervention (immobilisation in external rotation), it is unclear how the study will be classified when completed.

Further details of these studies are given in Characteristics of ongoing studies tables.

 

Risk of bias in included studies

We evaluated risk of bias at study level (although we noted some variation within studies at the level of individual outcomes and therefore will expand the risk of bias tables to allow for this in future iterations). Risk of bias for the seven domains varied across included studies (see Figure 2; Figure 3), although all were at some risk.

 FigureFigure 2. Risk of bias graph: authors' judgements about each risk of bias item presented as percentages across all included studies
 FigureFigure 3. Risk of bias summary: authors' judgements about each risk of bias item for each included study

 

Allocation

Selection bias is a consideration as some prediction of prognosis at the point of randomisation, particularly related to age and risk of re-dislocation, is possible and inferences might be drawn concerning individuals’ likely adherence to or acceptability of treatment protocols (Wood 2008). Finestone 2009 was at low risk of selection bias. At high risk were Itoi 2007, which probably lacked allocation concealment, and Taskoparan 2010, as the result of quasi-random sequence generation and lack of allocation concealment. Liavaag 2011, which used sealed envelopes, provided insufficient details to confirm allocation concealment and was judged to be at unclear risk of bias.

 

Blinding

The risk of performance bias was unclear in Finestone 2009 and Taskoparan 2010 as no information was provided on who applied the splints and gave initial instructions, and whether they were otherwise independent of the study. The risk of bias was high in Itoi 2007 and Liavaag 2011: in Itoi 2007, study co-authors applied the splints and gave initial instructions; and in Liavaag 2011, participants were informed of the preliminary results of Itoi 2007, which had favoured immobilisation in external rotation.

None of the study reports mentioned blinding of assessors. Despite this, Liavaag 2011 was judged to be at low risk of detection bias, because the primary outcome measure, re-dislocation, was clearly defined, and participant-reported re-dislocations were verified from medical records. The remaining studies and the secondary outcomes in Liavaag 2011 (subluxation or dislocation as a combined outcome, or subluxation alone) lacked such verification, leaving them vulnerable to detection bias. In addition, in Itoi 2007, although the primary outcomes (self-reported re-dislocation or subluxation) were each clearly defined, the latter was inevitably subjective; in Finestone 2009, a definition of "recurrent dislocation" was lacking; and in Taskoparan 2010, several outcomes were either susceptible to assessor influence or insufficiently defined to allow a judgement.

 

Incomplete outcome data

At low risk of attrition bias were Finestone 2009 (no loss to follow-up) and, in terms of its primary outcome, Liavaag 2011 (2.1% loss to follow-up). However, Itoi 2007 and the secondary outcomes of Liavaag 2011 were at high risk of attrition bias: for each, a worst-case scenario sensitivity analysis, assuming that approximately 50% of the dropouts in the external rotation group but none of the dropouts in the internal fixation group had an adverse outcome, resulted in a marked change in results. In Taskoparan 2010, also at high risk, there were large and unexplained losses to follow-up beyond six months.

 

Selective reporting

Liavaag 2011, the only included study for which a separately published a priori protocol was available, was at low risk of reporting bias, and Finestone 2009 was at unclear risk (although most key outcomes were reported). Itoi 2007 was at high risk (the start point and selection criteria varied across reports and may not have been determined prospectively, with related concerns regarding outcome assessment), as was Taskoparan 2010 (recurrent dislocation was not a prespecified outcome and the mechanisms and timings for gathering these data were not stated).

 

Other potential sources of bias

All of the reports specified their respective study eligibility criteria, although it was unclear in Itoi 2007 whether these had been prospectively established (see above). All studies had baseline comparability across groups.

Two of the four studies (Finestone 2009; Liavaag 2011) used commercially manufactured external rotation immobilisers from the outset, favouring standardisation, although Finestone 2009 did not specify the manufacturer. Itoi 2007 reported switching from ad hoc to commercially manufactured external rotation splints part way through the trial, with possible implications for positioning, consistency and adherence, and was marked down for this in the "other bias" section of the risk of bias tool. The report of Finestone 2009 included a conflict of interest statement specifying that no benefits had been or would be received from any commercial party. Liavaag 2011 did not include a conflict of interest statement, but their published protocol listed study sponsors and made no mention of the immobiliser's manufacturer. However, Itoi 2007 disclosed potentially substantial disbursements by the manufacturer of their immobilisers, raising the possibility of bias.

Neither Taskoparan 2010, who used ad hoc external rotation splints throughout, nor Itoi 2007 indicated how the intended position was determined. On this basis Taskoparan 2010 was marked "unclear" in the "other bias" section of the risk of bias tool. Itoi 2007 was categorised as "high risk" to account for uncertainties surrounding positioning and, as mentioned above, the switch to a commercially manufactured immobiliser mid-trial and the possibility of commercial influence.

The care programmes (i.e. other than immobilisation and related advice) appear to have been comparable for both groups in all studies.

 

Effects of interventions

See:  Summary of findings for the main comparison Immobilisation in external rotation compared with immobilisation in internal rotation for traumatic anterior dislocation of the shoulder

All four trials compared immobilisation of the affected arm in external rotation versus internal rotation.

We did not organise outcomes within our planned framework of short term (up to and including three months following dislocation), medium term (greater than three months and up to and including 12 months) and long term (longer than 12 months) because all four primary studies reported outcomes immediately after immobilisation (some immobilisation-related adverse events) and over a two-year or longer follow-up period, by which time point > 85% of re-dislocations would be expected to have occurred (Robinson 2006).

The effects of interventions are reported below (also see  Summary of findings for the main comparison). The quality of the evidence for all outcomes was judged to be 'very low'; this reflects in part the imprecision of the findings. This imprecision is more evident when considering the broad 95% confidence intervals (CI) for the illustrative absolute effects.

The proposed subgroup analyses were not undertaken. Although two included studies (Itoi 2007; Liavaag 2011) presented outcome data subgrouped by age, these pertained to different outcomes and different age categories and applied to small numbers. No usable subgroup data were presented in the primary studies related to gender, activity levels, recurrent versus first-time dislocations, nor the presence or absence of specific lesions resulting from dislocation (e.g. Bankart lesions).

 

Primary outcomes

 

Re-dislocation

Pooled data from three trials (Finestone 2009; Liavaag 2011; Taskoparan 2010) for re-dislocation over a two-year or longer follow-up showed very little difference between the two groups (RR 1.06 favouring internal rotation, 95% CI 0.73 to 1.54; P value 0.77; 252 participants; see  Analysis 1.1). In a low-risk population, with an illustrative baseline risk of 247 re-dislocations per 1000, this equates to 15 more (95% CI 67 fewer to 133 more) re-dislocations per 1000 following immobilisation in external rotation. In a medium-risk population, with an illustrative baseline risk of 436 re-dislocations per 1000, this equates to 26 more (95% CI 118 fewer to 235 more) re-dislocations per 1000 following immobilisation in external rotation. A sensitivity analysis in which Taskoparan 2010 (the study at greatest risk of bias) was removed did not prove influential (RR 1.13 favouring internal rotation, 95% CI 0.77 to 1.67; analysis not shown).

 

Validated patient-reported outcome measures for shoulder instability

One study (Liavaag 2011) reported results at two years of the WOSI, a validated patient-reported outcome measure for shoulder instability, in 174 people. The data were not normally distributed, and therefore analysis was non-parametric. The median score was 238 (interquartile range 101 to 707) in the external rotation group versus 375 (interquartile range 135 to 719) in the internal rotation group. Lower scores are better in the WOSI (maximum score 2100), but the difference was reportedly "not significant (p = 0.32)". No further analysis was possible.

 

Resumption of pre-injury activities

Two studies (Itoi 2007; Liavaag 2011) addressed different aspects of this outcome.

Itoi 2007 found higher return to sport at any level in the external rotation group over a two-year or longer follow-up among individuals who had sustained their initial injury during sport (RR 1.13, 95% CI 0.87 to 1.48; 109 participants, see  Analysis 1.2). In a medium-risk population, with an illustrative baseline risk of 633 participants per 1000 resuming sport at any level, this equates to 82 more (95% CI 82 fewer to 304 more) participants per 1000 resuming sport at any level following immobilisation in external rotation.

Itoi 2007 also reported return to sport at the pre-injury level over a two-year or longer follow-up and found in favour of external rotation, whereas Liavaag 2011 found no difference between the two groups in return to pre-injury level of activity in the same time frame. When pooled, these heterogeneous data (Chi2 was statistically significant at P value 0.09; I2 = 65%) favoured the external rotation group (RR 1.25, 95% CI 0.71 to 2.2; P value 0.43; 278 participants; see  Analysis 1.3). In a low -risk population, with an illustrative baseline risk of 204 participants per 1000 returning to their pre-injury level of activity, this equates to 41 more (95% CI 59 fewer to 245 more) participants per 1000 resuming activities at a pre-injury level following immobilisation in external rotation. In a medium-risk population, with an illustrative baseline risk of 605 participants per 1000 returning to their pre-injury level of activity, this equates to 161 more (95% CI 76 fewer to 395 more) participants per 1000 resuming activities at a pre-injury level following immobilisation in external rotation.

 

Secondary outcomes

 

Participant satisfaction with the intervention

No studies considered this outcome.

 

Validated quality of life outcome measures

No studies considered these outcomes.

 

Any instability: subluxation or subjective instability (either individually or grouped with dislocation as a composite outcome)

Two studies (Itoi 2007; Liavaag 2011) reported "any instability," in the form of subluxation or re-dislocation, with two-year or longer follow-up. Itoi 2007 found in favour of external rotation, whereas Liavaag 2011 found no between-group differences. When pooled, these heterogeneous data (Chi2 was statistically significant at P value 0.06; I2 = 72%) favoured the external rotation group (RR 0.82, 95% CI 0.5 to 1.33; P value 0.42; 322 participants; see  Analysis 1.4). In a medium-risk population, with an illustrative baseline risk of 484 instances of any instability per 1000, this equates to 87 fewer (95% CI 242 fewer to 160 more) participants with instability per 1000 following immobilisation in external rotation.

There were losses to follow-up of 20% in Itoi 2007 and 13% in Liavaag 2011 for this outcome, respectively posing "serious" and "intermediate" threats to validity (Straus 2005). A sensitivity analysis was therefore conducted, in which approximately half of losses to follow-up were imputed as events (worst-case scenario) in the external rotation groups but none of these losses were seen in the internal rotation groups. The pooled results of the sensitivity analysis favoured internal fixation (RR 1.06, 95% CI 0.84 to 1.34; see  Analysis 1.5) and thus illustrate that these losses to follow-up could pose a serious threat to the validity of the trial findings.

 

Important adverse events

None of the included studies specified adverse events as a priori outcomes, but all reported them ad hoc. Finestone 2009 reported an axillary rash in two (8%) of 24 participants who had been immobilised in internal rotation. Itoi 2007 reported temporary stiffness, resolving within a month or two with range-of-motion exercises, in six (7%) of 85 participants immobilised in external rotation and "no other problems related to immobilization". However, we judged that none of these temporary adverse events could be rated as "important".

There were three important adverse events reported. Liavaag 2011 reported two "complications" at unspecified time points: one participant (1%) of 91 in the external rotation group had hyperaesthesia and moderate hand pain, and one of 93 (1%) in the internal rotation group had eighth cervical dermatome paraesthesia. The other important event occurred in Taskoparan 2010, in which one participant (6%) of 16 in the internal rotation group had "30° limitation in abduction and 10 degrees in internal rotation in the 6th and 12th months. This patient was 75 years old and had additional rotator cuff problems". Unfortunately, Taskopraran did not clarify whether the limitations referred to were active (as with rotator cuff tear) or active and passive (as with frozen shoulder). Pooled data favoured external rotation (RR 0.61, 95% CI 0.08 to 4.46; 216 participants; see  Analysis 1.6). The imprecision of these results is clear from the absolute effect results: In a medium-risk population, these equate to 14 fewer (95% CI three fewer to 128 more) participants with an important adverse event per 1000 following immobilisation in external rotation.

 

Other outcomes

We intended to note any reports of service utilisation or resource use (e.g. length of hospital stay), outpatient attendance and the provision and nature of physiotherapy; and participants' adherence to their allocated interventions. Only the last of these was addressed by Finestone 2009, Itoi 2007 and Liavaag 2011.

In Finestone 2009, all participants reported "compliance with the protocol" except one (4%) of 27 in the external rotation group, who removed his splint two days early; Finestone 2009 did not consider this a deviation from protocol. In Itoi 2007, only 68 (80%) of 85 in the external rotation group and 50 (68%) of 74 participants in the internal rotation group wore their splints for the full three weeks. Of these, moreover, some only wore their splints part-time. In all, 61 of 85 participants (72%) in the external rotation group and 39 of 74 participants (53%) in the internal rotation group complied with the protocol. Liavaag 2011 reported that 63 of 93 participants (67.7%) in the external rotation group and 45 of 95 participants (47.4%) in the internal group used their splints for 16 hours or longer each day for at least 20 days.

 

Discussion

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
 

Summary of main results

This review now includes four trials with a total of 470 participants, of whom 412 were followed up for at least two years. There was only one comparison: immobilisation in external versus internal rotation for first-time, traumatic anterior dislocation of the shoulder. In relation to this comparison, there were data available for all of our three primary outcomes. Re-dislocation (Finestone 2009; Liavaag 2011; Taskoparan 2010) and resumption of activities (Itoi 2007; Liavaag 2011) enabled pooling for at least some aspects, and a validated patient-reported outcome measure (Western Ontario Shoulder Instability Index: WOSI) was presented by Liavaag 2011 but analysed using non-parametric statistics. Of our secondary outcome measures, the "any instability" outcome was addressed (Itoi 2007; Liavaag 2011), adverse events were reported by all, although on an ad hoc basis, and validated quality of life outcomes and participant satisfaction were not reported at all. No outcome had 95% confidence intervals sufficiently precise to demonstrate clear benefit for either position of immobilisation over the other. For this reason, and other reasons, the quality of the evidence was rated as "very low", meaning that "we are very uncertain about the estimate" ( Summary of findings for the main comparison).

The main results of this review, therefore, are twofold. First, robust evidence for superiority of immobilisation in external rotation over traditional immobilisation in a sling (internal rotation) is lacking, and there is no justification for recommending any change in current clinical practice. Second, we found no includable evidence related to our other objectives.

 

Overall completeness and applicability of evidence

Despite our reasonably comprehensive search, we located very few potentially eligible studies and included only four. The shortage of randomised controlled trials for conservative treatment parallels that concerning the treatment of proximal humeral fractures (Handoll 2003) and the comparison of conservative versus surgical treatment for anterior dislocation of the shoulder (Handoll 2004), and is not unexpected.

Three of the included studies (Itoi 2007; Liavaag 2011; Taskoparan 2010) consisted of mixed-gender, general populations; while Finestone 2009 included males only (whether by chance or intention is unclear), most of whom were military recruits. There was a wide age range (12 to 90 years) overall, though Liavaag 2011 imposed a 40-years upper age limit and the age range in Finestone 2009 (17 to 27 years) reflected the special population from which their participants were recruited. Overall, the young and active as well as the relatively sedentary are represented.

We located three other trials, presently described in the Characteristics of ongoing studies tables, whose results should appear in subsequent updates of this review. Two of these (combined target sample size of at least 50) compare immobilisation in external versus internal rotation, and one (target sample size 200) compares two types of physiotherapy after immobilisation in external rotation. Another seven studies are described in Characteristics of studies awaiting classification tables. Six of these (combined target sample size of at least 383) compare immobilisation in external rotation versus immobilisation in internal rotation. The remaining study, in press at the time of writing, compares different durations of shoulder restriction (zero, three or six weeks) by a band after immobilisation in external rotation (Itoi 2013).

Thus the included, ongoing and unclassified studies reveal an exclusive emphasis in research to date on immobilisation in external rotation, usually as a comparator against immobilisation in internal rotation, but occasionally as the standard immobilisation in studies comparing different post immobilisation regimens. No studies addressed other interventions of interest, involving comparisons of different durations of immobilisation, rehabilitation versus no rehabilitation and different variants of rehabilitation. These other issues remain relevant, as does the question of whether immobilisation is necessary at all for older people, who are at a much reduced risk of recurrence but at greater risk of shoulder stiffness (de Boer 2005). It is notable that but for the discovery of a report (published in 1999) that provides a full description of the method of treatment allocation, one well-cited trial (Hovelius 1983) testing duration of immobilisation might have been included (see Characteristics of excluded studies).

Also, some key outcomes are lacking in the primary research. Among the important outcomes that have not been directly addressed is participant satisfaction, including the acceptability of allotted interventions. In several of the included studies, participants' adherence to the protocol has served as a proxy for the latter aspect, but the atypical (mainly military) population in Finestone 2009 and the high risk of performance bias in Itoi 2007 and Liavaag 2011 confound this. Intuitively, one might expect maintenance of external rotation at the shoulder to be cumbersome. Additionally, one might reasonably expect a heightened risk of accidents. Yet no a priori strategies are in place to collect these or other adverse event data. Other important omissions are very long-term outcomes, notably persistent pain and arthropathy, as well as quality of life, using validated measures, at all time points.

The Cochrane review comparing surgical versus non-surgical treatment for anterior dislocation of the shoulder found some evidence from randomised controlled trials to support primary surgery in young adults (usually male) engaged in highly demanding physical activities who have sustained their first acute traumatic shoulder dislocation (Handoll 2004, updated in 2009). No evidence was available for other categories of participants. The review suggested that randomised controlled trials comparing good standard surgical intervention versus good standard conservative treatment for primary anterior shoulder dislocation are needed and anticipated that the present review of different conservative interventions including rehabilitation should provide important information in this area (Handoll 2004). The most important finding, however, of our review is the lack of good quality evidence to permit any recommendations for practice or to inform on the best comparator for trials of surgical versus non-surgical management. Conclusive evidence on the efficacy of immobilisation in external rotation would inform this but is presently lacking. In this light, it is a frustrating limitation of the present review that six completed studies comparing external versus internal rotation are classified as "awaiting classification".

 

Quality of the evidence

In aggregate, the quality of the evidence was "very low", mostly reflecting limitations in study design (all outcomes) and imprecision of point estimates (all outcomes) as well as inconsistency ("resumption of sport/activities at pre-injury level, with two-year or longer follow-up" and "any instability") and indirectness ("important adverse events"). This grading means that we are very uncertain about the estimates of effect ( Summary of findings for the main comparison). A universally ad hoc approach to collecting data on adverse events hampers assessment of the potential for harms. In addition, poor reporting of how the desired position of external rotation was achieved in locally manufactured splints (Itoi 2007, Taskoparan 2010) and of the manufacturer's details of commercial splints (Finestone 2009) undermines the applicability of the results.

The previous version of our review (Handoll 2006) contained only one study (Itoi 2003). Itoi 2013 was a preliminary report whose findings favoured immobilisation in external rotation, although not statistically significantly so. We reported: "[this study] does not provide the robust and sufficient evidence required to establish clinical benefit. As well as starting off using quasi-randomised methods and then insufficient methods to guarantee allocation concealment, the outcome assessment of Itoi 2003 is notably flawed. For instance, trials should measure the recovery to pre-injury levels of all participants and actively record recurrence at set times. Holding the arm in external rotation is more hazardous and awkward for people and so some better monitoring of acceptability, adherence and accidents should also be done. Particularly given that external rotation immobilisers are now available on the commercial market it is important that good quality randomised controlled trials of external rotation versus internal rotation are conducted by independent investigators."

In the present version of the review, Itoi 2003 has been replaced by Itoi 2007. This was a comparatively large, and potentially influential, study of a sample reportedly distinct from Itoi 2003 (personal communication with Prof Itoi, 8 April 2011), with some methodological improvements over its predecessor. Thus there was randomisation, return to activity was evaluated in all participants and there was active recording of outcomes at or after two years, as well as reporting on adherence and adverse events. On the other hand, the start point and the selection criteria are inconsistent across reports (Itoi 2003; Itoi 2004; Itoi 2007) and may not have been determined prospectively, leading us to downgrade the study to an "unclear risk" of reporting bias. Furthermore, allocation does not appear to have been concealed (tending to cancel any benefit of randomisation). There were also serious problems with losses to follow-up, such that the favourable results were not robust to sensitivity analysis; there was vulnerability to performance bias and detection bias; and the risk of reporting bias was unclear.

Of the three other studies included, Taskoparan 2010 was very compromised methodologically, and its results should be viewed with particular circumspection. For this study, performance bias, attrition bias and other bias were rated "unclear risk" and all else "high risk". This was a small study, however, and the imprecision of its results meant that it was not influential in any meta-analysis. Finestone 2009 and Liavaag 2011 were somewhat stronger methodologically. Both reported adequate randomisation, although allocation concealment was unclear in Liavaag 2011. But neither had a low risk of performance bias (Finestone 2009: unclear risk; Liavaag 2011: high risk), and only one (Liavaag 2011) had a low risk of detection bias (Finestone 2009: high risk). Finestone 2009 had a low risk of attrition bias, however, as did Liavaag 2011 for its primary outcome. The combined re-dislocation or subluxation outcome in Liavaag 2011 was at high risk of attrition bias, but, as a secondary outcome, this did not affect the "low risk" grading given using the 'Risk of bias' tool. Liavaag 2011 was at low risk of reporting bias and Finestone 2009, unclear risk.

 

Potential biases in the review process

We strove throughout the development of this review to minimise any potential for biases. Thus, when feasible, we adhered throughout to the detailed a priori protocol, which detailed every aspect of the review's aims, objectives and methods, and noted any necessary changes in Differences between protocol and review. We conducted a reasonably comprehensive search without language restriction, and the key processes of study selection, data extraction and risk of bias evaluation were each independently performed by at least two review authors.

We contacted study authors for missing data and, when appropriate, methodological information. However, it has been shown empirically that unclear reporting of allocation concealment is itself associated with inflated effect estimates for subjective outcomes (Schulz 1995; Wood 2008); therefore, disregarding such instances would have meant ignoring a source of bias. We therefore made judgements on the satisfactoriness of allocation concealment based on the description given in the study report, narratively interpreting the grading given in relation to specific outcomes (i.e. subjective or objective) and did not contact authors for clarification of safeguards.

As previously indicated (see Overall completeness and applicability of evidence), we recognise the large number of studies awaiting classification as an unavoidable limitation of our review.

 

Agreements and disagreements with other studies or reviews

We identified three systematic reviews (Gibson 2004; Paterson 2010; Smith 2006) evaluating aspects of conservative care following closed reduction, that is, whether to immobilise, the position in which to immobilise, how long to immobilise and how to rehabilitate, in various combinations. The outcomes of interest were any outcomes (Smith 2006), recurrent dislocation (Gibson 2004; Paterson 2010), resumption of pre-dislocation activity (Gibson 2004; Smith 2006) and functional outcomes (Gibson 2004). All differed from our own methodologically in the inclusion of observational as well as experimental study designs.

Gibson 2004 concluded that "weak evidence" favoured immobilisation for three weeks over one week in terms of recurrence and functional outcomes, although those immobilised for one week returned to work sooner. However, among the studies supporting this was only one (Kiviluoto 1980) that was reportedly experimental, and this had been excluded by ourselves in this review. The conclusions of Smith 2006 were similar to our own, that is, it is unclear whether shoulders should be immobilised after anterior dislocation, for how long and whether such immobilisation should be in internal or external rotation. More optimistic were Paterson 2010, who concluded, "there is no benefit of conventional sling immobilisation for longer than one week ... in younger patients", but based this upon Hovelius 1983 and its follow-ups and Kiviluoto 1980; both studies were excluded from our review. Paterson 2010 also concluded that, "bracing in external rotation may provide a clinically important benefit over traditional sling immobilisation, but the difference in recurrence rates did not achieve significance with the numbers available". We would downplay this further, based on the results of our own review, for two reasons. First, our review is more current. It includes Liavaag 2011, a study of moderately high quality that failed to replicate the encouraging results of Itoi 2003 and Itoi 2007, both of which were at much greater risk of bias. Second, we believe that our review is more robust, as it excludes Itoi 2003, thereby avoiding the potential risk of including data from duplicate populations, and it identifies the potential for high risk of bias of Itoi 2007 by recognising that the start point and the selection criteria of this trial vary across reports and may not have been determined prospectively, raising a question of selective reporting bias.

 

Authors' conclusions

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

 

Implications for practice

All available evidence concerns comparison of immobilisation in external rotation, a relatively novel technique, versus immobilisation in internal rotation, the traditional approach to management following closed reduction of anterior dislocation of the shoulder. There is no evidence that either approach is more effective than the other, and none of the included studies collected data on adverse events with sufficient rigour to enable proper assessment of potential harms. There is no justification for recommending that practice be changed.

In general, there is a lack of evidence from randomised controlled trials to inform the choice of conservative management following closed reduction of traumatic dislocation of the shoulder.

 
Implications for research

There remains a need for sufficiently powered, high quality and appropriately reported (i.e. CONSORT-compliant) randomised controlled trials of key conservative treatment and rehabilitation options for traumatic anterior shoulder dislocation. Blinding of interventions is not easy to do, but concealed allocation should always be done and, when possible, blinded outcome measurement should be done, as these would improve the quality and validity of future results.

Trials should include evaluation of the use and duration of immobilisation (for example, one week versus three weeks) and timing for resumption of activities that may provoke a recurrence. For these trials, we suggest that some distinction should be made between young adults engaged in highly demanding physical activities, who are at greater risk of recurrence, and older adults who have lower risk of recurrence but are likely to have pre-existing degenerative disease of the rotator cuff.

Attention should be given to outcome assessment in future trials. The use of well-defined and validated functional outcome measures, including participant-derived quality of life measures, is preferable, and individual participant data should be made available. Other important outcomes include participant satisfaction and adverse events. Collection of adverse events data ad hoc, in the absence of pre-defined definitions or strategies for data collection, is a serious flaw that casts doubt on the completeness of data and hampers comparison of risks and benefits. In future studies, key categories of potential adverse events should be established prospectively, and an active strategy should be put in place for collecting these data. Categories should be reported on even if they contain no events.

To ensure that efforts are not duplicated, researchers should consult trial registries before planning further research in this area. This particularly relates to the comparison between immobilisation in external versus internal rotation, along with research that is complementary to these; in these areas, pressing priorities include completion of ongoing work and publication of completed work.

 

Acknowledgements

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

We are very grateful to Lesley Gillespie for developing the search strategy for this review, for searching the Cochrane Bone, Joint and Muscle Trauma Group's Specialised Register and for providing help during editorial processing; to Joanne Elliott for updating the search; and to Lindsey Elstub, Diane Horsley, Laura MacDonald and Helen Handoll for providing editorial support. We thank Mario Lenza and Piet de Boer for providing editorial comments. We additionally thank Helen Handoll for her contribution as lead author in the previous version of this review.

We thank Eiji Itoi, Sigurd Liavaag, Charles Milgrom, Stéphane Pelet, Alison Wakefield and Timothy Walker for providing information on their trials, Mavis Luya for chasing up information on another trial and Yan Gong and Mingming Zwang for translating the methods of a potentially eligible study that was published in Chinese.

 

Data and analyses

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
Download statistical data

 
Comparison 1. Immobilisation in external versus internal rotation

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Re-dislocation,with two-year or longer follow-up3252Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.73, 1.54]

 2 Resumption of sport at any level, with two-year or longer follow-up1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 3 Resumption of sport/activities at pre-dislocation level, with two-year or longer follow-up2278Risk Ratio (M-H, Random, 95% CI)1.25 [0.71, 2.20]

    3.1 Resumption of sport at the pre-dislocation level (subgroup who dislocated during sport)
1109Risk Ratio (M-H, Random, 95% CI)1.80 [0.94, 3.43]

    3.2 Resumption of pre-injury activities (all participants)
1169Risk Ratio (M-H, Random, 95% CI)1.02 [0.80, 1.29]

 4 Any instability (subluxation or re-dislocation), with two-year or longer follow-up2322Risk Ratio (M-H, Random, 95% CI)0.82 [0.50, 1.33]

 5 Any instability (subluxation or re-dislocation), with two-year or longer follow-up: 'worst-case' sensitivity analysis2386Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.84, 1.34]

 6 Important adverse events2216Risk Ratio (M-H, Fixed, 95% CI)0.61 [0.08, 4.46]

 

Appendices

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
 

Appendix 1. Search strategies (2005 to present)

Please note the searches were carried out in 2 stages:
First search: August 2005 to October 2012.
Supplementary search: October 2012 to September 2013.

 

The Cochrane Library (Wiley Online Library)

#1 MeSH descriptor: [Shoulder Dislocation] this term only  (88)    
#2 (shoulder* near dislocat*) or (shoulder* near sublux*) or (shoulder* near instability) or (shoulder* near unstable):ti,ab,kw (Word variations have been searched)  (201)    
#3 (glenohumeral next joint) or (glenohumeral next instability) or (glenohumeral next unstable):ti,ab,kw (Word variations have been searched)  (56)    
#4 (lesion* near/3 hill next sachs) or (lesion* near/3 bankart):ti,ab,kw (Word variations have been searched)  (20)    
#5 #1 or #2 or #3 or #4   (246)          
#6 immobilis* or immobiliz* or sling* or conservativ* or therap* or physiother* or rehabilitat* or mobilis* or mobiliz* or train* or exercis* or (physical next therap*):ti,ab,kw (Word variations have been searched)  (241953)    
#7 MeSH descriptor: [Exercise] this term only  (8288)    
#8 MeSH descriptor: [Rehabilitation] 3 tree(s) exploded  (12120)    
#9 Any MeSH descriptor with qualifier(s): [Rehabilitation - RH, Therapy - TH] in all MeSH products  (67572)    
#10 #6 or #7 or #8 or #9   (270647)          
#11 #5 and #10  (137)          
#12 SR-muskinj  (7174)          
#13 #11 not #12   (57) [trials]

Supplementary search (2012 to Sept 2013):
#13 #11 not #12 (1) [trials]

 

MEDLINE (Ovid Web)

1 Shoulder Dislocation/ (4573)
2 (shoulder$ adj3 (dislocat$ or sublux$ or instability or unstable)).tw. (3877)
3 (glenohumeral adj (joint or instability or unstable)).tw. (1843)
4 (lesion$1 adj (Hill Sachs or Bankart)).tw. (10)
5 or/1-4 (7063)
6 (immobilis$ or immobiliz$ or sling$ or conservativ$ or therap$ or physiother$ or rehabilitat$ or mobilis$ or mobiliz$ or train$ or exercis$ or physical therap$).tw. (2163712)
7 Exercise/ or exp Rehabilitation/ (197506)
8 (rh or th).fs. (1477224)
9 or/6-8 (3235953)
10 and/5,9 (2310)
11 Randomized controlled trial.pt. (339605)
12 Controlled clinical trial.pt. (85425)
13 randomized.ab. (242346)
14 placebo.ab. (135629)
15 Drug Therapy.fs. (1578525)
16 randomly.ab. (173863)
17 trial.ab. (251056)
18 groups.ab. (1136962)
19 or/11-18 (2939707)
20 exp Animals/ not Humans/ (3797751)
21 19 not 20 (2497281)
22 10 and 21 (268)
23 (200508* or 200509* or 200510* or 200511* or 200512* or 2006* or 2007* or 2008* or 2009* or 2010* or 2011* or 2012*).ed. (5375215)
24 22 and 23 (128)

Supplementary search (Oct 2012 to Sept 2013):
24 22 and 23 (17)

 

EMBASE (Ovid Web)

1 Shoulder Dislocation/ or Bankart Lesion/ (4516)
2 (shoulder$ adj3 (dislocat$ or sublux$ or instability or unstable)).tw. (4648)
3 (glenohumeral adj (joint or instability or unstable)).tw. (2234)
4 (lesion$1 adj (Hill Sachs or Bankart)).tw. (11)
5 or/1-4 (8191)
6 (immobilis$ or immobiliz$ or sling$ or conservativ$ or therap$ or physiother$ or rehabilitat$ or mobilis$ or mobiliz$ or train$ or exercis$ or physical therap$).tw. (2855947)
7 (rh or th).fs. (1359978)
8 Conservative Treatment/ or Physiotherapy/ or exp Exercise/ or Rehabilitation/ (287688)
9 or/6-8 (3834171)
10 and/5,9 (2810)
11 exp Randomized Controlled Trial/ (331217)
12 exp Double Blind Procedure/ (111497)
13 exp Single Blind Procedure/ (16539)
14 exp Crossover Procedure/ (35309)
15 Controlled Study/ (3890318)
16 or/11-15 (3969729)
17 ((clinical or controlled or comparative or placebo or prospective$ or randomi#ed) adj3 (trial or study)).tw. (652284)
18 (random$ adj7 (allocat$ or allot$ or assign$ or basis$ or divid$ or order$)).tw. (159069)
19 ((singl$ or doubl$ or trebl$ or tripl$) adj7 (blind$ or mask$)).tw. (148185)
20 (cross?over$ or (cross adj1 over$)).tw. (63302)
21 ((allocat$ or allot$ or assign$ or divid$) adj3 (condition$ or experiment$ or intervention$ or treatment$ or therap$ or control$ or group$)).tw. (199932)
22 or/17-21 (974005)
23 or/16,22 (4451730)
24 limit 23 to human (2701949)
25 and/10,24 (488)
26 (2005* or 2006* or 2007* or 2008* or 2009* or 2010* or 2011* or 2012*).em. (7902638)
27 25 and 26 (288)

Supplementary search (Oct 2012 to Sept 2013):
27 25 and 26 (25)

 

CINAHL (EBSCO)

S1  (MH "Shoulder Dislocation")  (725)
S2  TI ( (shoulder N3 dislocat*) or (shoulder N3 sublux*) or (shoulder N3 instability) or (shoulder N3 unstable) ) OR AB ( (glenohumeral N3 joint) or (glenohumeral N3 instability) or (glenohumeral N3 unstable) )  (1126)
S3  TI ( (glenohumeral N3 joint) or (glenohumeral N3 instability) or (glenohumeral N3 unstable) ) OR AB ( (glenohumeral N3 joint) or (glenohumeral N3 instability) or (glenohumeral N3 unstable) )  (591)
S4  TI ( (lesion* N3 Hill Sachs) or (lesion* N3 Bankart) ) OR AB ( (lesion* N3 Hill Sachs) or (lesion* N3 Bankart) )  (127)
S5  S1 or S2 or S3 or S4  (1618)
S6  TI ( (immobilis* or immobiliz* or sling* or conservativ* or therap* or physiother* or rehabilitat* or mobilis* or mobiliz* or train* or exercis* or physical therap*) ) OR AB ( (immobilis* or immobiliz* or sling* or conservativ* or therap* or physiother* or rehabilitat* or mobilis* or mobiliz* or train* or exercis* or physical therap*) )  (371609)
S7  (MH "Rehabilitation+")  (153920)
S8  MW rh OR MW th  (336486)
S9  S6 or S7 or S8  (683613)
S10  S5 and S9  (731)
S11  (MH "Clinical Trials+")  (149457)
S12  (MH "Evaluation Research+")  (18850)
S13  (MH "Comparative Studies")  (68744)
S14  (MH "Crossover Design")  (9756)
S15  PT Clinical Trial  (73931)
S16  (MH "Random Assignment")  (33559)
S17  S11 or S12 or S13 or S14 or S15 or S16  (240443)
S18  TX ((clinical or controlled or comparative or placebo or prospective or randomi?ed) and (trial or study))  (412564)
S19  TX (random* and (allocat* or allot* or assign* or basis* or divid* or order*))  (58804)
S20  TX ((singl* or doubl* or trebl* or tripl*) and (blind* or mask*))  (640484)
S21  TX ( crossover* or 'cross over' ) or TX cross n1 over  (12256)
S22  TX ((allocat* or allot* or assign* or divid*) and (condition* or experiment* or intervention* or treatment* or therap* or control* or group*))  73797 S23  S18 or S19 or S20 or S21 or S22  (974727)
S24  S17 or S23  (1034060)
S25  S10 and S24  (324)
S26  EM 2005 OR EM 2006 OR EM 2007 OR EM 2008 OR EM 2009 OR EM 2010 OR EM 2011 OR EM 2012  (2365064)
S27  S25 and S26  (208)

Supplementary search (Oct 2012 to Sept 2013):
S27 S25 and S26 (37)

 

Appendix 2. Previous searches (to September 2005)

We identified nine studies, only one (Itoi 2003) of which was included in the previous version of this review. Five studies were excluded, three of which are reported in full (Hovelius 1983; Kiviluoto 1980; Xu 2003) and two of which (Harper 2000; Staply 2002) were listed only in the National Research Register UK, and are now presumed abandoned. A report for Wakefield 2001 was apparently in preparation (personal communication, 25 June 2005), but this trial is now also presumed abandoned (see Characteristics of excluded studies table). Details of Pimpalnerkar 2008 (ISRCTN48254181) and Itoi 2006, which is now in press (Itoi 2013), are provided in the Characteristics of ongoing studies table.

 

What's new

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

Last assessed as up-to-date: 1 March 2014.


DateEventDescription

1 March 2014New search has been performedFor this version of the review, published in 2014, Issue 4, the following changes were made.

1. The search was updated to September 2013.
2. Four new trials (Finestone 2009; Itoi 2007; Liavaag 2011; Taskoparan 2010) were included, and one previously included trial (Itoi 2003) was excluded.
3. In accordance with the policy of The Cochrane Collaboration, the review was updated to include new methodology, including assessment of risk of bias.
4. A 'Summary of findings' table was added.

1 March 2014New citation required and conclusions have changedAlthough the review conclusions still point to an overall lack of evidence to inform practice, the inclusion of four new trials, all of which compared immobilisation in external rotation versus immobilisation in the traditional position of internal rotation, brought a specific focus to the conclusions.

Changes were made to the byline, with one new review author and removal of two previous review authors.



 

History

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

Protocol first published: Issue 4, 2004
Review first published: Issue 1, 2006


DateEventDescription

5 September 2008AmendedConverted to new review format.



 

Contributions of authors

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

The review update was developed by Nigel Hanchard (NH), Lorna Goodchild (LG) and Lucksy Kottam (LK). NH contacted authors of eligible trials to inform choices for study inclusion and to ask for extra information. All review authors performed trial selection, quality assessment and data extraction. NH compiled the first draft of the review and received critical feedback from LG and LK. Nigel Hanchard is the guarantor of the review.

 

Declarations of interest

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

Nigel CA Hanchard: none known
Lorna M Goodchild: none known
Lucksy Kottam: none known

 

Sources of support

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
 

Internal sources

  • University of Teesside, Middlesbrough, UK.

 

External sources

  • The Physiotherapy Research Foundation of the Chartered Society of Physiotherapy Charitable Trust (registered charity 279882), UK.

 

Differences between protocol and review

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

In line with recommendations of The Cochrane Collaboration, the review now assesses risk of bias.

For this version of the review, outcomes were revised and, to comply with current guidance of The Cochrane Collaboration, the number of primary outcomes was reduced. We used GRADE to judge the quality of the evidence and have incorporated a summary of findings table:  Summary of findings for the main comparison.

As indicated in the Results, we anticipated organising outcomes within a framework of short term (up to and including three months following dislocation), medium term (greater than three months and up to and including 12 months) and long term (longer than 12 months). Imposition of this framework was not necessary because all included studies reported outcomes in a mutually compatible framework: during or shortly after immobilisation (some adverse events) or up to or beyond two years post dislocation.

* Indicates the major publication for the study

References

References to studies included in this review

  1. Top of page
  2. AbstractRésumé scientifique
  3. Summary of findings
  4. Background
  5. Objectives
  6. Methods
  7. Results
  8. Discussion
  9. Authors' conclusions
  10. Acknowledgements
  11. Data and analyses
  12. Appendices
  13. What's new
  14. History
  15. Contributions of authors
  16. Declarations of interest
  17. Sources of support
  18. Differences between protocol and review
  19. Characteristics of studies
  20. References to studies included in this review
  21. References to studies excluded from this review
  22. References to studies awaiting assessment
  23. References to ongoing studies
  24. Additional references
  25. References to other published versions of this review
Finestone 2009 {published data only}
  • Finestone A, Milgrom C, Radeva-Petrova DR, Rath E, Barchilon V, Beyth S, et al. Bracing in external rotation for traumatic anterior dislocation of the shoulder. Journal of Bone & Joint Surgery - British Volume 2009;91(7):918-21.
  • Milgrom C. Personal communication 5 October 2009.
Itoi 2007 {published data only}
  • Itoi E. Personal communication 8 April 2011.
  • Itoi E. Personal communication July 2005.
  • Itoi E, Hatakeyama Y, Sato T, Kido T, Minagawa H, Yamamoto N, et al. Immobilization in external rotation after dislocation of the shoulder reduces the risk of recurrence [platform presentation]. American Academy of Orthopaedic Surgeons Annual Meeting; 2007 Feb 14-18; San Diego (CA). 2007.
  • Itoi E, Hatakeyama Y, Sato T, Kido T, Minagawa H, Yamamoto N, et al. Immobilization in external rotation after shoulder dislocation reduces the risk of recurrence: a randomized controlled trial. Journal of Bone & Joint Surgery - American Volume 2007;89(10):2124-31.
Liavaag 2011 {published data only}
  • Liavaag S. Personal communication 21 April 2013.
  • Liavaag S, Brox JI, Pripp AH, Enger M, Soldal LA, Svenningsen S. Immobilization in external rotation after primary shoulder dislocation did not reduce the risk of recurrence: a randomized controlled trial. Journal of Bone & Joint Surgery - American Volume 2011;93(10):897-904.
  • Liavaag S, Stiris MG, Lindland ES, Enger M, Svenningsen S, Brox JI. Do Bankart lesions heal better in shoulders immobilized in external rotation? A randomized single-blind study of 55 patients examined with MRI. Acta Orthopaedica 2009;80(5):579-84.
  • Svenningsen S. Does immobilization of the shoulder in external rotation reduce the recurrence rate of shoulder dislocation?. http://clinicaltrials.gov/show/NCT00202735 (accessed 12 November 2012).
Taskoparan 2010 {published data only}
  • Taskoparan H, Kilincoglu V, Tunay S, Bilgic S, Yurttas Y, Komurcu M. Immobilization of the shoulder in external rotation for prevention of recurrence in acute anterior dislocation. Acta Orthopaedica et Traumatologica Turcica 2010;44(4):278-84.

References to studies excluded from this review

  1. Top of page
  2. AbstractRésumé scientifique
  3. Summary of findings
  4. Background
  5. Objectives
  6. Methods
  7. Results
  8. Discussion
  9. Authors' conclusions
  10. Acknowledgements
  11. Data and analyses
  12. Appendices
  13. What's new
  14. History
  15. Contributions of authors
  16. Declarations of interest
  17. Sources of support
  18. Differences between protocol and review
  19. Characteristics of studies
  20. References to studies included in this review
  21. References to studies excluded from this review
  22. References to studies awaiting assessment
  23. References to ongoing studies
  24. Additional references
  25. References to other published versions of this review
Chutkan 2012 {published data only}
  • Chutkan NB. Immobilization in external rotation after primary shoulder dislocation did not reduce the risk of recurrence: a randomized controlled trial. Orthopedics 2012;35(7):610-1.
Harper 2000 {unpublished data only}
  • Harper W. Anterior shoulder dislocations in the over 45 years of age. A prospective randomised study. In: National Resarch Register, Issue 1, 2005. Oxford: Update Software. http://www.nrr.nhs.uk/ViewDocument.asp?ID=N0122017162 (accessed 12 May 2005).
Hovelius 1983 {published data only}
  • Arciero RA, Taylor DC. Primary anterior dislocation of the shoulder in young patients. A ten-year prospective study [letter]. Journal of Bone and Joint Surgery - American Volume 1998;80(2):299-300.
  • Hovelius L. Anterior dislocation of the shoulder in teenagers and young adults. Five year prognosis. Journal of Bone and Joint Surgery - American Volume 1987;69(3):393-9.
  • Hovelius L. The natural history of primary anterior dislocation of the shoulder in the young. Journal of Orthopaedic Science 1999;4(4):307-17.
  • Hovelius L, Augustini BG, Fredin H, Johansson O, Norlin R, Thorling J. Primary anterior dislocation of the shoulder in young patients. A ten-year prospective study. Journal of Bone and Joint Surgery - American Volume 1996;78(11):1677-84.
  • Hovelius L, Eriksson K, Fredin H, Hagberg G, Hussenius A, Lind B, et al. Recurrences after initial dislocation of the shoulder. Results of a prospective study of treatment. Journal of Bone and Joint Surgery - American Volume 1983;65(3):343-9.
  • Hovelius L, Lind B, Thorling J. Primary dislocation of the shoulder. Factors affecting the two-year prognosis. Clinical Orthopaedics and Related Research 1982;(176):181-5.
  • Kirkley S. Primary anterior dislocation of the shoulder in young patients. A ten-year prospective study [letter]. Journal of Bone and Joint Surgery - American Volume 1998;80(2):300-1.
Itoi 2003 {published data only}
  • Itoi E. Personal communication 10 July 2005.
  • Itoi E, Hatakeyama Y, Kido T, Sato T, Minagawa H, Wakabayashi I, et al. A new method of immobilization after traumatic anterior dislocation of the shoulder: a preliminary study. Journal of Shoulder and Elbow Surgery 2003;12(5):413-5.
  • Itoi E, Hatakeyama Y, Kido T, Sato T, Minagawa H, Wakabayashi I, et al. A new method of immobilization in dislocation of the shoulder: a prospective randomized study [abstract]. Annual Meeting of the American Academy of Orthopaedic Surgeons; 2003 February 5-9; New Orleans [LA]. http://www.aaos.org/wordhtml/anmt2003/sciprog/200.htm (accessed 01 October 2003).
  • Itoi E, Hatakeyama Y, Sato T, Kido T, Minagawa H, Wakabayashi I, et al. Immobilization in external rotation after shoulder dislocation: an interim report of an ongoing trial [abstract]. Annual Meeting of the American Academy of Orthopaedic Surgeons; 2004 March 10-14; San Francisco (CA). http://www.aaos.org/wordhtml/anmt2004/sciprog/071.htm (accessed 07 April 2004).
Kiviluoto 1980 {published data only}
  • Kiviluoto O, Pasila M, Jaroma H, Sundholm A. Immobilization after primary dislocation of the shoulder. Acta Orthopaedica Scandinavica 1980;51(6):915-9.
Staply 2002 {unpublished data only}
  • Luya M. Personal communication 6 June 2005.
  • Staply S. Anterior shoulder trial dislocation external rotation trial. In: National Resarch Register, Issue 1, 2005. Oxford: Update Software. http://www.nrr.nhs.uk/ViewDocument.asp?ID=N0284109750 (accessed 12 May 2005).
Wakefield 2001 {unpublished data only}
  • Wakefield A. Personal communication 24 June 2005.
  • Wakefield A. The role of physiotherapy in the prevention of recurrence of anterior shoulder dislocation. In: National Research Register, Issue 1, 2005. Oxford: Update Software. http://www.nrr.nhs.uk/ViewDocument.asp?ID=N0519070803 (accessed 12 May 2005).
Whelan 2010 {published data only}
  • Whelan D. Immobilization in an external or internal rotation brace did not differ in preventing recurrent shoulder dislocation. Journal of Bone and Joint Surgery - American Volume 2010;92(5):1262.
Xu 2003 {published data only}
  • Xu Q, Gong Y, Lan Z, Xue C. Effects of systematic rehabilitation treatment on the stability of shoulder in young patients with shoulder dislocation. Zhongguo Linchuang Kangfu [Chinese Journal of Clinical Rehabilitation] 2003;14(7):2050-1.

References to studies awaiting assessment

  1. Top of page
  2. AbstractRésumé scientifique
  3. Summary of findings
  4. Background
  5. Objectives
  6. Methods
  7. Results
  8. Discussion
  9. Authors' conclusions
  10. Acknowledgements
  11. Data and analyses
  12. Appendices
  13. What's new
  14. History
  15. Contributions of authors
  16. Declarations of interest
  17. Sources of support
  18. Differences between protocol and review
  19. Characteristics of studies
  20. References to studies included in this review
  21. References to studies excluded from this review
  22. References to studies awaiting assessment
  23. References to ongoing studies
  24. Additional references
  25. References to other published versions of this review
ISRCTN41070054 {unpublished data only}
  • Nicolaou N. Splintage in external rotation for anterior glenohumeral dislocation: a prospective randomised and controlled study. WHO International Clinical Trials Registry Platform: http://apps.who.int/trialsearch/Trial.aspx?TrialID=ISRCTN41070054 (accessed 12 November 2012).
ISRCTN48254181 {unpublished data only}
  • Pimpalnerker A. A comparison study of internal versus external rotation immobilisation for primary anterior shoulder dislocation. WHO International Clinical Trials Registry Platform: http://apps.who.int/trialsearch/Trial.aspx?TrialID=ISRCTN48254181 (accessed 12 November 2012).
Itoi 2013 {published data only}
  • Itoi E, Hatakeyama Y, Itoigawa Y, Omi R, Shinozaki N, Yamamoto N, et al. Is protecting the healing ligament beneficial after immobilization in external rotation for an initial shoulder dislocation?. American Journal of Sports Medicine 2013;41(5):1126-32.
Kelly 2011 {unpublished data only}
  • Kelly CP, Smith HJ, Kuiper JH. External rotation bracing compared to conventional sling in first time anterior shoulder dislocation (abstract). British Elbow and Shoulder Society 22nd Annual Scientific Meeting; 2011 June 22-24; Newcastle (UK) http://www.bess.org.uk/pages/meetings/meetings-archive/abstracts-archive.php?aid=393&abstract=763 (accessed 14 June 2013) 2011.
  • Kuiper JH, Smith HJ, Wales J, Kelly CP. External rotation bracing compared to conventional sling in first time anterior shoulder dislocation – The Shoulder Orthosis Study (SOS). Institute of Orthopaedics - Annual Report 2010/2011 http://www.orthopaedic-institute.org/images/user/Institute%20Report%202011_Web.pdf (accessed 14 June 2013).
Miller 2007 {published data only}
  • Miller BS, Cole EM, Sonnabend D, Kaar SG. Sling vs external rotation brace for shoulder dislocations: preliminary results of a randomized trial [poster presentation]. American Academy of Orthopaedic Surgeons Annual Meeting; 2007 Feb 14-18; San Diego (CA) 2007.
NCT00707018 {unpublished data only}
  • McCarty E. Immobilization in external rotation after first time anterior shoulder dislocation: a prospective randomized study. WHO International Clinical Trials Registry Platform: http://apps.who.int/trialsearch/Trial.aspx?TrialID=NCT00707018 (accessed 12 November 2012).
Whelan 2008 {published data only}
  • Litchfield RB. A randomized evaluation of immobilization in external rotation in the management of acute anterior dislocations of the shoulder. http://clinicaltrials.gov/show/NCT00196560 (accessed 12 November 2012).
  • Whelan D, Litchfield RB, Boorman RS, Dainty K, Wambolt E, Chan DS, et al. A randomized evaluation of immobilization in external rotation after primary shoulder dislocation [abstract]. American Academy of Orthopaedic Surgeons 75th Annual Meeting; 2008 Mar 5-9; San Francisco (CA) 2008.

References to ongoing studies

  1. Top of page
  2. AbstractRésumé scientifique
  3. Summary of findings
  4. Background
  5. Objectives
  6. Methods
  7. Results
  8. Discussion
  9. Authors' conclusions
  10. Acknowledgements
  11. Data and analyses
  12. Appendices
  13. What's new
  14. History
  15. Contributions of authors
  16. Declarations of interest
  17. Sources of support
  18. Differences between protocol and review
  19. Characteristics of studies
  20. References to studies included in this review
  21. References to studies excluded from this review
  22. References to studies awaiting assessment
  23. References to ongoing studies
  24. Additional references
  25. References to other published versions of this review
ACTRN12611001183976 {unpublished data only}
  • Walker T. Personal communication 13 November 2012.
  • Walker T. A randomised controlled trial on the effect of physiotherapy and an external rotation brace on redislocation rate and shoulder function in patients aged 15-40 years with a first time anterior shoulder dislocation. WHO International Clinical Trials Registry Platform: http://apps.who.int/trialsearch/Trial.aspx?TrialID=ACTRN12611001183976 (accessed 12 November 2012).
NCT01111500 {unpublished data only}
  • Pelet S. Personal communication 21 January 2013.
  • Pelet S, Cote H. First time anterior glenohumeral joint dislocation with a Bankart lesion in young patients: which type of immobilization should be chosen? A prospective randomized study. WHO International Clinical Trials Registry Platform: http://apps.who.int/trialsearch/Trial.aspx?TrialID=NCT01111500 (accessed 12 November 2012).
NCT01648335 {published data only}
  • NCT01648335. A prospective study of the effect of treatment of first time traumatic shoulder anterior dislocation by immobilization in external rotation on the incidence of recurrent dislocation. WHO Clinical Trials Registry Platform. http://apps.who.int/trialsearch/Trial.aspx?TrialID=NCT01648335 (accessed 1 November 2012). [: NCT01648335]

Additional references

  1. Top of page
  2. AbstractRésumé scientifique
  3. Summary of findings
  4. Background
  5. Objectives
  6. Methods
  7. Results
  8. Discussion
  9. Authors' conclusions
  10. Acknowledgements
  11. Data and analyses
  12. Appendices
  13. What's new
  14. History
  15. Contributions of authors
  16. Declarations of interest
  17. Sources of support
  18. Differences between protocol and review
  19. Characteristics of studies
  20. References to studies included in this review
  21. References to studies excluded from this review
  22. References to studies awaiting assessment
  23. References to ongoing studies
  24. Additional references
  25. References to other published versions of this review
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