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Therapeutic ultrasound for chronic low-back pain

  1. Safoora Ebadi1,
  2. Nicholas Henschke2,*,
  3. Noureddin Nakhostin Ansari1,
  4. Ehsan Fallah3,
  5. Maurits W van Tulder4

Editorial Group: Cochrane Back and Neck Group

Published Online: 14 MAR 2014

Assessed as up-to-date: 1 OCT 2013

DOI: 10.1002/14651858.CD009169.pub2


How to Cite

Ebadi S, Henschke N, Nakhostin Ansari N, Fallah E, van Tulder MW. Therapeutic ultrasound for chronic low-back pain. Cochrane Database of Systematic Reviews 2014, Issue 3. Art. No.: CD009169. DOI: 10.1002/14651858.CD009169.pub2.

Author Information

  1. 1

    Tehran University of Medical Sciences, Department of Physiotherapy, Faculty of Rehabilitation, Tehran, Tehran, Iran

  2. 2

    University of Heidelberg, Institute of Public Health, Heidelberg, Germany

  3. 3

    Army University of Medical Sciences of the I.R. Iran, Emam Reza Hospital, Tehran, Iran

  4. 4

    VU University, Department of Health Sciences, Faculty of Earth and Life Sciences, Amsterdam, Netherlands

*Nicholas Henschke, Institute of Public Health, University of Heidelberg, Im Neuenheimer Feld 324, Heidelberg, 69120, Germany. nhenschke@georgeinstitute.org.au.

Publication History

  1. Publication Status: New
  2. Published Online: 14 MAR 2014

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Characteristics of included studies [ordered by study ID]
Ansari 2006

MethodsRCT conducted in outpatient physiotherapy clinic (secondary care setting)


Participants15 participants were randomised, who were aged 18-65 with non-radiating non-specific low back pain (NSLBP) lasting for more than 3 months. Exclusion criteria were: abnormal neurological status; concomitant severe disease; psychiatric illness; current psychotherapy; pathological lumbosacral X-rays (except for minor degenerative changes); rheumatic inflammatory disease; planned hospitalisation; addiction to any kind of substance; and any contraindication to ultrasound therapy.


InterventionsIntervention (I) group (n = 5) received 1MHz continuous ultrasound, at 1.5 W/cm2 for 10 sessions, 3 days per week. Duration of US application was calculated according to the formula: Total treatment time = Planned average local exposure time x (tissue area/effective radiation area of applicator).

Control (C) group (n = 5) received sham ultrasound for 10 sessions, 3 days per week.


OutcomesMean (SD) pre- and post-treatment scores on Functional Rating Index were: (I) 56.5 (20.35), 34.5 (13.5); and (C) 46.95 (14.38), 39.9 (16.5). Mean (SD) pre- and post-treatment degrees of flexion range of motion were: (I) 117.4 (2.5), 128.6 (14.3); and (C) 103.4 (13.39), 109.2 (10.6). Mean (SD) pre- and post-treatment degrees of extension range of motion were: (I) 23.8 (4.15), 30 (6.4); and (C) 27.2 (3.03), 29 (4.2).

No between group difference was seen for H-reflex parameters (electroneurophysiological evaluation) or in lumbar spine lateral flexion (left and right) range of motion.


NotesNo conflict of interest declared with regard to commercial funding.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod for determining randomisation sequence not reported in text

Allocation concealment (selection bias)Unclear riskNot reported in text

Blinding of participants and personnel (performance bias)
Participants
Low riskParticipants blinded to group allocation

Blinding of participants and personnel (performance bias)
Care providers
High riskCare providers not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskPrimary outcome measure is self-reported

Incomplete outcome data (attrition bias)
Dropout rate described
High riskDropout rate described, 30% of sample dropped out

Incomplete outcome data (attrition bias)
Intention-to-treat
High riskParticipants who dropped out were excluded from analysis

Selective reporting (reporting bias)Low riskResults for all outcome measure reported

Similar groupsHigh riskLarge differences in gender, age, BMI between groups

Co-interventionsLow riskParticipants advised not to commence new treatments

ComplianceHigh riskHigh proportion of dropouts due to noncompliance

Timing of outcome measuresLow riskSimilar timing of outcome assessment (post-treatment) for both groups

Durmus 2010a

MethodsRCT conducted in unknown setting (not reported)


ParticipantsForty-two patients (29 females and 13 males) with CLBP lasting for at least 3 months were included in the study. Patients were excluded from the study for the following reasons: evidence for acute radiculopathy; the presence of an inflammatory disease, neoplastic disease, spondylolysis, spondylolisthesis or sacroiliitis; lumbar disc herniation requiring surgical treatment; vertebral fractures; pregnancy.


InterventionsIntervention (I) group (n = 21) patients received hot packs (15 minutes), ultrasound, and exercise. In group 1, 1MHz continuous ultrasound was applied to the lumbar paravertebral region at an intensity of 1 W/cm2 for 10 minutes using a probe with an effective radiating area of 5 cm2.

Control (C) group (n = 21) patients received hot packs (15 minutes), sham ultrasound, and exercise. Sham ultrasound was applied to the same region for the same duration, with the same ultrasound device. No current was applied but the device and the indicator lights were kept in the "on" position.

Both groups performed range of motion, stretching (hamstring, pelvic, and abdominal muscles) and strengthening (cervical, thoracic, and lumbar region muscles) exercises for 15 minutes. Patients were treated 5 days a week for 3 weeks.


OutcomesMedian (range) scores on the modified Oswestry Low Back Pain Disability Questionnaire pre- and post-treatment were: (I) 38 (26-76), 12 (1-32); and (C) 44 (22-50), 17 (6-23). Median (range) scores on the VAS at rest pre- and post-treatment were: (I) 6 (3-10), 2 (1-5); and (C) 6 (3-9), 4 (1-9).

Significantly greater improvement was observed in (I) compared to (C) in Pain Disability Index scores, 6-minute walk test, emotional and physical role functioning (SF-36), functional performance, and depression.


NotesAttempts made to contact authors for further data - as all data were reported as median (range) - with no response.

No conflict of interest declared with regard to commercial funding.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod for determining randomisation sequence not reported in text

Allocation concealment (selection bias)Unclear riskNot reported in text

Blinding of participants and personnel (performance bias)
Participants
Low riskParticipants blinded to group allocation

Blinding of participants and personnel (performance bias)
Care providers
High riskCare providers not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskPrimary outcome measures are self-reported

Incomplete outcome data (attrition bias)
Dropout rate described
Low riskNo dropouts reported

Incomplete outcome data (attrition bias)
Intention-to-treat
Low riskNo dropouts reported, presumed complete outcome data available

Selective reporting (reporting bias)Low riskResults for all outcome measure reported

Similar groupsLow riskGroups well matched at baseline

Co-interventionsUnclear riskNot reported in text

ComplianceUnclear riskNot reported in text

Timing of outcome measuresLow riskSimilar timing of outcome assessment (post-treatment) for both groups

Durmus 2010b

MethodsRCT conducted in outpatient department (secondary care setting)


Participants68 female patients who had been experiencing low back pain for at least 3 months were included. Exclusion criteria were: acute radicular signs or symptoms, radiographic evidence of inflammatory disease affecting the spine, tumour, spondylolysis, spondylolisthesis, or sacroiliitis, serious medical conditions for which exercise would be contraindicated, neuromuscular or dermatologic disease that involves the lumbar and abdominal area, were currently in an exercise program, implanted cardiac pacemaker or defibrillator, contracture, previous trauma, history of spinal surgery, pregnancy, presence of severe structural deformity.


InterventionsGroup 1 (n = 20) was given an electrical stimulation program and back and abdominal exercises (45 min).

Group 2 (n = 19) was given a 10-minute ultrasound treatment (1 MHz frequency and 1 W/cm2 intensity and a transducer head with an area of 5 cm, an effective radiating area of 4 cm, and a BNR of 1:5) and back and abdominal exercises (45 min).

Group 3 (n = 20) acted as the control group and was given only back and abdominal exercises (45 min).

All of the programs were 45 minutes per session, performed 3 days a week, for a duration of 6 weeks. Patients were evaluated pre-treatment and in the third and sixth weeks of the therapy.


OutcomesFifty-nine patients completed the study. The post-treatment (6-week) between group comparison did not show a significant difference in Pain Disability Index, Oswestry Disability Questionnaire, range of motion (modified lumbar Schober, lumbar Schober, fingertip to floor distance), 6-minute walk distance, or muscle strength between the three groups.

There was a significantly greater improvement in physical function, energy, and social function scores of the SF-36, VAS, and muscle endurance in groups 1 and 2 compared to group 3. There was no significant difference between groups 1 and 2 in these outcomes.


NotesNo conflict of interest declared with regard to commercial funding.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod for determining randomisation sequence not reported in text

Allocation concealment (selection bias)Unclear riskNot reported in text

Blinding of participants and personnel (performance bias)
Participants
High riskParticipants not blinded to intervention

Blinding of participants and personnel (performance bias)
Care providers
High riskCare providers not blinded

Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported primary outcome, patient not blinded to intervention

Incomplete outcome data (attrition bias)
Dropout rate described
Low riskDescribed and acceptable

Incomplete outcome data (attrition bias)
Intention-to-treat
High riskDropouts excluded from analysis

Selective reporting (reporting bias)Low riskResults for all outcome measure reported

Similar groupsLow riskGroups well matched at baseline

Co-interventionsUnclear riskNot reported in text

ComplianceUnclear riskNot reported in text

Timing of outcome measuresLow riskSimilar timing of outcome assessment (post-treatment) for both groups

Durmus 2013

MethodsRCT conducted in outpatient department (secondary care setting)


Participants64 female patients who had been experiencing low back pain for at least 3 months were included. Exclusion criteria were: acute radicular signs or symptoms, radiographic evidence of inflammatory disease affecting the spine, tumour, spondylolysis, spondylolisthesis, or sacroiliitis, serious medical conditions for which exercise would be contraindicated, neuromuscular or dermatologic disease that involves the lumbar and abdominal area, were currently in an exercise program, implanted cardiac pacemaker or defibrillator, contracture, previous trauma, history of spinal surgery, pregnancy, presence of severe structural deformity.


InterventionsGroup 1 (n = 20) was given a group-exercise program for 60 min, 3 times per week for 6 weeks.

Group 2 (n = 20) was given a 10-minute ultrasound treatment (1 MHz frequency and 1.5 W/cm2 intensity and a transducer head with an area of 5 cm, an effective radiating area of 4 cm, and a BNR of 1:5), 3 times per week for 6 weeks, and the same exercise program as group 1.

Group 3 (n = 20) was given phonophoresis therapy by applying 2-3 mm of capsaicin gel (10% capsicum oleoresin in 0.22% solution) then a 10-minute ultrasound treatment (as per group 2), 3 times per week for 6 weeks, as well as the same exercise program as group 1.

Patients were evaluated pre-treatment and after 6 weeks (post-treatment).


OutcomesSixty patients completed the study. The post-treatment (6-week) between group comparison showed a significant difference in VAS pain, walking performance (6-minute walk test), and extensor muscle strength in favour of groups 2 and 3 compared to group 1. There was no significant difference between groups 2 and 3.

There was a significantly greater improvement in pain, physical function, and energy subgroups of the SF-36 in group 3 compared to groups 1 and 2.


NotesNo conflict of interest declared with regard to commercial funding.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod for determining randomisation sequence not reported in text

Allocation concealment (selection bias)Unclear riskNot reported in text

Blinding of participants and personnel (performance bias)
Participants
High riskParticipants not blinded to intervention

Blinding of participants and personnel (performance bias)
Care providers
High riskCare providers not blinded

Blinding of outcome assessment (detection bias)
All outcomes
High riskSelf-reported primary outcome, patient not blinded to intervention

Incomplete outcome data (attrition bias)
Dropout rate described
Low riskDescribed and acceptable

Incomplete outcome data (attrition bias)
Intention-to-treat
High riskDropouts excluded from analysis

Selective reporting (reporting bias)Low riskResults for all outcome measure reported

Similar groupsLow riskGroups well matched at baseline

Co-interventionsLow riskMedication controlled during intervention period

ComplianceUnclear riskNot reported in text

Timing of outcome measuresLow riskSimilar timing of outcome assessment (post-treatment) for both groups

Ebadi 2012

MethodsRCT conducted in outpatient department (secondary care setting)


Participants50 patients aged between 18 and 60 with non-specific chronic low back pain were randomised. Exclusion criteria were: nerve root symptoms; systemic disease and specific conditions such as neoplasm, fractures, spondylolisthesis, spondylolysis, spinal stenosis, ankylosing spondylitis; previous low back surgery; taking medication for specific psychological problems; and pregnancy. Patients were recruited from three university hospitals in Tehran, Iran.


InterventionsThe intervention (I) group (n = 24) received continuous ultrasound plus semi-supervised exercise. Continuous ultrasound with a frequency of 1 MHz and an intensity of 1.5 W/cm2 was applied to the painful paravertebral low back region. The duration of US was estimated for each patient using the formula: Total treatment time = Planned average local exposure time x (tissue area/effective radiation area of applicator).

The (C) control group (n = 24) received sham ultrasound plus semi-supervised exercise. Sham ultrasound involved the machine being turned on, with lights visible to the patient, but no current being applied.

All patients in both groups received 10 sessions of treatment, three times a week, every other day.


Outcomes48 participants completed treatment sessions. Mean (SD) pre- and post-treatment scores for VAS were: (I) 46.6 (17.7), 26.6 (13.8); and (C) 49 (16), 30.7 (13.1). Mean (SD) pre- and post-treatment scores for Functional Rating Index were: (I) 40.8 (14.6), 23.4 (6.9); and (C) 43.9 (16.9), 31.1 (13.4). Changes in lumbar range of motion, muscle endurance, and median frequency slope of all measured paravertebral muscles were not significantly different between groups.


NotesNo conflict of interest declared with regard to commercial funding.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated randomisation schedule

Allocation concealment (selection bias)Low riskRandomisation was performed using opaque sealed envelopes

Blinding of participants and personnel (performance bias)
Participants
Low riskParticipants blinded to group allocation

Blinding of participants and personnel (performance bias)
Care providers
High riskCare providers not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskPrimary outcome measure is self-reported

Incomplete outcome data (attrition bias)
Dropout rate described
Low riskDescribed and acceptable

Incomplete outcome data (attrition bias)
Intention-to-treat
Low riskAll randomised patients included in analysis

Selective reporting (reporting bias)Low riskResults for all outcome measures reported

Similar groupsLow riskGroups well matched at baseline

Co-interventionsLow riskParticipants advised not to commence new treatments

ComplianceUnclear riskNot reported in text

Timing of outcome measuresLow riskSimilar timing of outcome assessment (post-treatment) for both groups

Grubisic 2006

MethodsRCT conducted in specialist clinic (secondary care setting)


Participants31 patients, aged 38-77, with low back pain lasting more than 3 months and intensity of pain on VAS at least 50mm were randomised. Exclusion criterion was non-mechanical low back pain.


InterventionsIntervention (I) group (n = 15) received ultrasound to the paravertebral muscles at an intensity of 1.2 W/cm2 for 5 minutes plus kinesitherapy over 10 sessions in two weeks.

Control (C) group (n = 16) received sham ultrasound plus kinesitherapy over ten sessions in two weeks.


OutcomesMean (SD) pre- and post-treatment scores on VAS were: (I) 82.7 (14.0), 79.8 (12.2); and (C) 81.7 (12.1), 78.9 (12.1). Mean (SD) pre- and post-treatment range of motion (cm) measures were: (I) 5.7 (0.8), 5.8 (0.9); and (C) 5.4 (0.9), 5.6 (1.0).

There was no significant difference between groups regarding patient and physician global perceived efficacy.


NotesArticle originally published in Croatian.

No conflict of interest declared with regard to commercial funding.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMethod for determining randomisation sequence not reported in text

Allocation concealment (selection bias)High riskNot reported in text

Blinding of participants and personnel (performance bias)
Participants
Low riskParticipants blinded to group allocation

Blinding of participants and personnel (performance bias)
Care providers
High riskCare providers not blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskPrimary outcome measure is self-reported

Incomplete outcome data (attrition bias)
Dropout rate described
Unclear riskNot reported in text

Incomplete outcome data (attrition bias)
Intention-to-treat
Unclear riskNot reported in text

Selective reporting (reporting bias)Low riskResults for all outcome measure reported

Similar groupsLow riskGroups well matched at baseline

Co-interventionsUnclear riskNot reported in text

ComplianceUnclear riskNot reported in text

Timing of outcome measuresLow riskSimilar timing of outcome assessment (post-treatment) for both groups

Mohseni-Bandpei 2006

MethodsRCT conducted in outpatient physiotherapy department (secondary care setting)


ParticipantsOne hundred and twenty patients aged between 18 and 55 years with pain greater than 3 months were recruited and randomised into two groups of 60. Participants were excluded if they had an underlying disease such as malignancy, obvious disc herniation, osteoporosis, viscerogenic causes, infection or systemic disease of the musculoskeletal system; previous spinal manipulation therapy or ultrasound treatment; neurologic or sciatic nerve root compression, radicular pain, sensory disturbances, loss of strength and reflexes; previous back surgery; evidence of previous vertebral fractures or major structural abnormality; tumour of the spine; pregnancy; devices such as heart
pacemakers that may be affected by electrical stimulation; or registered disabled or receiving any type of benefits because of their LBP.


InterventionsThe manipulation/exercise group (n = 56) received spinal manipulation with an exercise programme. On average, each patient was seen for four sessions (range two to seven sessions), once or twice per week.

The ultrasound/exercise group (n = 56) received ultrasound with the same exercise programme. Continuous ultrasound with a frequency of 1MHz and intensity between 1.5 and 2.5 W/cm2 for a period of 5–10 minutes was applied. On average, each patient was seen for six sessions (range three to 11 sessions), once or twice per week.


Outcomes112 patients completed the study. Post-treatment, between-group analysis showed that patients in the manipulation/exercise group demonstrated a significantly greater reduction in pain intensity and functional disability, as well as improved lumbar flexion and extension than the ultrasound/exercise group. No significant difference was found between the two groups for measures of median frequency for either the multifidus or the iliocostalis lumborum muscle. A significant difference was found in the median frequency slope between the two groups for multifidus alone in favour of the manipulation/exercise group. These differences persisted at the 6 months follow-up.


NotesNo conflict of interest declared with regard to commercial funding.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Block style randomization scheme" with reference

Allocation concealment (selection bias)Unclear riskNot reported in text

Blinding of participants and personnel (performance bias)
Participants
High riskParticipants not blinded to intervention

Blinding of participants and personnel (performance bias)
Care providers
High riskCare providers not blinded to group

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskOutcome assessor blinded to group allocation, however primary outcome was self-reported and participants were not blinded to intervention

Incomplete outcome data (attrition bias)
Dropout rate described
Low riskDescribed and acceptable

Incomplete outcome data (attrition bias)
Intention-to-treat
High riskDroupouts excluded from analysis

Selective reporting (reporting bias)Low riskResults for all outcome measure reported

Similar groupsLow riskGroups well matched at baseline

Co-interventionsUnclear riskNot reported in text

ComplianceUnclear riskNot reported in text

Timing of outcome measuresLow riskSimilar timing of outcome assessment (post-treatment) for both groups

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Acar 2012Not patients with LBP

Allen 2006Not a randomised controlled trial

Bertocco 2002Ultrasound as part of treatment package

Borman 2003Not a randomised controlled trial

Brockow 1997All groups had ultrasound – no control intervention

Charlusz 2010Patients with acute low-back pain

Chipchase 2003Not a randomised controlled trial

Cloonan 1987Not a randomised controlled trial

Draper 1993Not a randomised controlled trial

Fiore 2011Patients with acute low-back pain

Foster 1999Not a randomised controlled trial

Gorbunov 1997Not a randomised controlled trial

Goren 2010Patients with lumbar spinal stenosis

Greenough 2009Not a randomised controlled trial

Gurer 2005Ultrasound as part of treatment package

Haas 2004Ultrasound as part of treatment package

Hamm 2003Not a randomised controlled trial

Hurwitz 2002Ultrasound as part of treatment package

Jia 2003Ultrasound as part of treatment package

Kiralp 2009Not a randomised controlled trial

Koes 1992Ultrasound as part of treatment package

Koes 1992aUltrasound as part of treatment package

Koes 1993Ultrasound as part of treatment package

Koldas 2008Ultrasound as part of treatment package

Kumar 2009aUltrasound as part of treatment package

Kumar 2009bUltrasound as part of treatment package

Kumar 2010Ultrasound as part of treatment package

Leistner 1989Not a randomised controlled trial

Li 2007Ultrasound as part of treatment package

Lopes 2009Not a randomised controlled trial

Morrisette 2004Not a randomised controlled trial

Nordin 1999Not a randomised controlled trial

Nwuga 1983Patients with acute low back pain

Onel 1993Not a randomised controlled trial

Pensri 2005Not a randomised controlled trial

Poitras 2005Not a randomised controlled trial

Poitras 2008Not a randomised controlled trial

Roman 1960Not a randomised controlled trial

Rush 1994Not a randomised controlled trial

Sahin 2004Not a randomised controlled trial

Santiesteban 1984Patients with acute low-back pain

Scott 2010Not a randomised controlled trial

Si 2005Not a randomised controlled trial

Tajali 2009Abstract only, no full-text available

Tander 2005Not a randomised controlled trial

Timm 1994Ultrasound as part of treatment package

Tonev 2010Ultrasound as part of treatment package

Unlu 2008Patients with acute low back pain

Wagner 1995Not a randomised controlled trial

Whitman 2006Patients with lumber spinal stenosis; ultrasound as part of treatment package

Wiesinger 1997Not a randomised controlled trial

 
Characteristics of studies awaiting assessment [ordered by study ID]
Licciardone 2013

MethodsRCT with 2 x 2 factorial design

Participants455 patients aged 21 to 69 years with low back pain for at least 3 months recruited through newspaper advertisements, community agencies, and medical clinics. Exclusion criteria included pregnancy, red flag conditions (cancer, spinal osteomyelitis, spinal fracture, herniated disc, ankylosing spondylitis, or cauda equina syndrome); low back surgery in the past year; workers' compensation benefits in the past 3 months; ongoing litigation involving back problems; angina or congestive heart failure symptoms with minimal activity, history of a stroke, or transient ischemic attack in the past year;
implanted biomedical devices (such as cardiac pacemakers or artificial joints); active bleeding or infection in the lower back, or other conditions impeding protocol implementation; use of corticosteroids in the past month; or use of manual treatment (osteopathic or manual therapies delivered by chiropractors or physical therapists) or therapeutic ultrasound in the past 3 months or more than 3 times in the past year. Candidates whose screening was successful by telephone
received a clinical screening to exclude those with a high probability of lumbar radiculopathy, a relative contraindication to osteopathic manual therapy (OMT).

InterventionsPatients were allocated to four groups: OMT plus ultrasound, OMT plus sham ultrasound, sham OMT plus ultrasound, or sham OMT plus sham ultrasound.

Treatments were scheduled at weeks 0, 1, 2, 4, 6, and 8 using 15 different physicians. Patients could self-initiate low back pain co-interventions, such as non-prescription drugs, complementary and alternative medicine therapies or usual care.

OutcomesThe current level of low back pain was measured before each treatment and at week 12 using a 100-mm visual analog scale. Secondary outcomes were measured at baseline and at weeks 4, 8, and 12, using the Roland-Morris Disability Questionnaire (RMDQ), Medical Outcomes Study Short Form-36 Health Survey general health scale (SF-36 GH), number of lost work days in the past 4 weeks because of low back pain, and satisfaction with back care on a 5-point Likert scale.

NotesData are not reported for the four randomized groups. Presented data are for main effects of OMT (i.e. OMT plus ultrasound and OMT plus sham ultrasound together), sham OMT (i.e. sham OMT plus ultrasound and sham OMT plus sham ultrasound together), ultrasound (i.e. OMT plus ultrasound and sham OMT plus ultrasound together), and sham ultrasound (i.e. OMT plus sham ultrasound and sham OMT plus sham ultrasound together). Therefore data on the effectiveness of therapeutic ultrasound could not be separated from that of OMT.

 
Comparison 1. Ultrasound vs. sham ultrasound

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

 1 Pain (VAS) post-treatment3121Mean Difference (IV, Random, 95% CI)-7.12 [-17.99, 3.75]

 2 Back-specific functional status post-treatment3100Std. Mean Difference (IV, Fixed, 95% CI)-0.45 [-0.84, -0.05]

 3 Flexion ROM post-treatment389Std. Mean Difference (IV, Random, 95% CI)0.18 [-0.62, 0.98]

 4 Extension ROM post-treatment258Std. Mean Difference (IV, Fixed, 95% CI)-0.33 [-0.85, 0.19]

 
Comparison 2. Ultrasound in addition to exercise vs. exercise alone

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

 1 Pain (PDI) post-treatment279Mean Difference (IV, Fixed, 95% CI)-2.16 [-4.66, 0.34]

 2 Back-specific functional status post-treatment279Mean Difference (IV, Fixed, 95% CI)-0.41 [-3.14, 2.32]

 3 Flexion ROM post-treatment279Mean Difference (IV, Fixed, 95% CI)0.02 [-0.52, 0.56]

 
Summary of findings for the main comparison.

Therapeutic ultrasound for chronic low-back pain

Patient or population: Adults with chronic low-back pain

Settings: Secondary care

Intervention: Therapeutic ultrasound

Comparison: Sham (placebo) ultrasound

OutcomesIllustrative comparative risks* (95% CI)No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

PlaceboTherapeutic ultrasound

Pain intensity

Visual analogue scale (100-point scale); post-treatment
*The mean outcome for the most representative study (Ebadi 2012) is 30.7 (SD 13.1)The mean pain intensity in the intervention groups was 7.12 points lower (17.99 lower to 3.75 higher)121 (3)⊕⊕⊝⊝
low1,2
No statistically significant difference

Back-specific functional status

Functional Rating Index or Oswestry Disability Questionnaire (higher scores mean worse function); post-treatment
*The mean outcome for the most representative study (Ebadi 2012) is 31.1 (SD 13.4)The mean back-specific functional status in the intervention groups was 0.45 standard deviations lower (0.84 lower to 0.05 higher)100 (3)⊕⊕⊕⊝
moderate1
The magnitude of this difference is small to moderate.

Flexion ROM post-treatment

Modified Schober method (cm) or fingertip-to-floor method (cm); post-treatment
*The mean outcome for the most representative study (Ebadi 2012) is 59.8 (SD 17.9)The mean flexion ROM in the intervention groups was 0.18 standard deviations higher (0.62 lower to 0.98 higher)89 (3)⊕⊝⊝⊝
very low1,2,3
No statistically significant difference

Extension ROM post-treatment

Modified Schober method (cm) or degrees; post-treatment
*The mean outcome for the most representative study (Ebadi 2012) is 24.1 (SD 9.3)The mean extension ROM in the intervention groups was 0.33 standard deviations lower (0.85 lower to 0.19 higher)58 (2)⊕⊕⊕⊝
moderate1
No statistically significant difference

*Of the included trials for this outcome, we chose the study that is a combination of the most representative study population and the lowest risk of bias (Ebadi 2012). This figure represents the mean outcome in the control group of this particular study.

CI: Confidence interval; RR: Risk Ratio; SD: Standard Deviation; ROM: Range of Motion

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.

 1. Total number of events was < 300
2. I2 > 60%
3. Two of the three included trials were rated as having a high risk of bias
 
Summary of findings 2.

Therapeutic ultrasound for chronic low-back pain

Patient or population: Adults with chronic low-back pain

Settings: Secondary care

Intervention: Therapeutic ultrasound plus exercise

Comparison: Exercise

OutcomesIllustrative comparative risks* (95% CI)No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ExerciseTherapeutic ultrasound plus exercise

Pain intensity

Pain Disability Index (70-point scale); post-treatment
*The mean change for the most representative study (Durmus 2013) is 10.7 (SD 4.4)The mean pain intensity in the intervention groups was 2.16 points lower (4.66 lower to 0.34 higher)79 (2)⊕⊕⊝⊝
low1,2
No statistically significant difference

Back-specific functional status

Oswestry Disability Questionnaire (percentage); post-treatment
*The mean change for the most representative study (Durmus 2013) is 8.2 (SD 7.2)The mean back-specific functional status in the intervention groups was 0.41 percent lower (3.14 lower to 2.32 higher)79 (2)⊕⊕⊝⊝
low1,2
No statistically significant difference

Flexion ROM post-treatment

Lumbar Schober method (cm); post-treatment
*The mean change for the most representative study (Durmus 2013) is 0.38 (SD 1.41)The mean flexion ROM in the intervention groups was 0.02 cm higher (0.52 lower to 0.56 higher)79 (2)⊕⊕⊝⊝
low1,2
No statistically significant difference

Extension ROM post-treatmentNot measuredNot measuredNot applicableNot applicable

*Of the included trials for this outcome, we chose the study that had the lowest risk of bias (Durmus 2013). This figure represents the mean change in the control group of this particular study.

CI: Confidence interval; RR: Risk Ratio; SD: Standard Deviation; ROM: Range of Motion

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.

 1. Total number of events was < 300
2. Both included studies were rated as having a high risk of bias.
 
Table 1. Clinical relevance

StudyPatients described in detailInterventions describedRelevant outcomes reportedSize of the effectBenefit/harm

Ansari 2006YesYesNoNoNo

Durmus 2010aYesYesYesNoNo

Durmus 2010bYesYesYesNoNo

Durmus 2013YesYesYesNoNo

Ebadi 2012YesYesYesNoNo

Grubisic 2006NoYesYesNoNo

Mohseni-Bandpei 2006YesYesYesNoNo