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Nonoperative treatment for lumbar spinal stenosis with neurogenic claudication

  1. Carlo Ammendolia1,*,
  2. Kent J Stuber2,
  3. Elisabeth Rok3,
  4. Raja Rampersaud4,
  5. Carol A Kennedy5,
  6. Victoria Pennick6,
  7. Ivan A Steenstra7,
  8. Linda K de Bruin8,
  9. Andrea D Furlan5

Editorial Group: Cochrane Back and Neck Group

Published Online: 30 AUG 2013

Assessed as up-to-date: 15 JUL 2013

DOI: 10.1002/14651858.CD010712


How to Cite

Ammendolia C, Stuber KJ, Rok E, Rampersaud R, Kennedy CA, Pennick V, Steenstra IA, de Bruin LK, Furlan AD. Nonoperative treatment for lumbar spinal stenosis with neurogenic claudication. Cochrane Database of Systematic Reviews 2013, Issue 8. Art. No.: CD010712. DOI: 10.1002/14651858.CD010712.

Author Information

  1. 1

    Rebecca MacDonald Centre for Arthritis and Autoimmune Diseases, Toronto, ON, Canada

  2. 2

    Canadian Memorial Chiropractic College, Division of Graduate Eduation and Research, Calgary, Alberta, Canada

  3. 3

    Mount Sinai Hospital, Samuel Lunenfeld Research Institute, Toronto, ON, Canada

  4. 4

    Toronto Western Hospital, Division of Orthopedics, University Health Network, Toronto, ON, Canada

  5. 5

    Institute for Work & Health, Toronto, ON, Canada

  6. 6

    The Cochrane Collaboration, Cochrane Editorial Unit, London, UK

  7. 7

    Institute of Work and Health, Workplace studies, Toronto, Ontario, Canada

  8. 8

    Haarlem, Netherlands

*Carlo Ammendolia, Rebecca MacDonald Centre for Arthritis and Autoimmune Diseases, 60 Murray Street, Room L2007, Toronto, ON, M5T 3L9, Canada. cammendolia@mtsinai.on.ca. cammendolia@iwh.on.ca.

Publication History

  1. Publication Status: New
  2. Published Online: 30 AUG 2013

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Characteristics of included studies [ordered by study ID]
Amundsen 2000

MethodsRandomized Controlled Trial


Participants100 subjects, 54 male, 46 female, median age of 59 (males were 1.5 years higher than females). Median back pain duration was 14 years, median duration of sciatica was 2 years

Setting: Neurology department in a hospital in Norway


Interventions1) Surgery – partial or total laminectomy, medial facetecomy, discectomy, and/or removal of osteophytes from the vertebral margins or facet joints.  No fusions. (n=13)

2) Conservative therapy - "lumbar orthosis use for 1 month worn during the day for all activities plus instruction and back school.” (n=18)


Outcomes1) VAS

2) Verbal Rating Scale

3) Subjective Change (Better, Worse, or Unchanged)

4) Work Status

5) Subjective rating from evaluating physician and study team (Excellent, Fair, Unchanged, Worse)

 

Follow-up: 6 months, 1, 4 and 10 years


NotesVAS = Visual Analogue Scale


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High risk

Allocation concealment (selection bias)Unclear riskInformation currently not available

Was the patient blinded to the intervention?Low risk

Was the care provider blinded to the intervention?Low risk

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

Was the drop-out rate described and acceptable?High risk

Were all randomized participants analyzed in the group to which they were allocated?High risk

Selective reporting (reporting bias)High risk

Were the groups similar at baseline regarding the most important prognostic indicators?Low risk

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?Low risk

Was the timing of the outcome assessment similar in all groups?Unclear riskInformation currently not available

Cuckler 1985

MethodsRandomized Controlled Trial


Participants73 subjects in total, 37 with spinal stenosis, 36 with acute herniated nucleus pulposus, 37 males, 36 female, average age of 48.5 years in the experimental group and 49.5 years in the placebo group. Experimental group average 36.6 months in symptom duration, placebo group averaged 29.4 months

Setting: Orthopedic surgery department in the United States


Interventions1) Steroid group - 2mL of sterile water containing 80mg of methylprednisolone acetate combined with 5mL of 1% procaine was injected into the epidural space in the region between the 3rd and 4th lumbar vertebrae with the patient in the lateral decubitus position lying on the side of the painful limb (n=42, 20 with stenosis)

2) Placebo group - 2mL of saline combined with 5mL of 1% procaine was injected into the epidural space in the region between the 3rd and 4th lumbar vertebrae with the patient in the lateral decubitus position lying on the side of the painful limb. (n=31, 17 with stenosis)

 

All patients were advised to take mild analgesics (aspirin or acetaminophen) during the post-injection period. Second injection given if less than 50% improvement after 24 hours - considered treatment failure


Outcomes1) Subjective percentage of improvement with 75% required to be considered a treatment improvement, if less than 50% after 24 hours was considered a treatment failure

2) Re-injection Rates

3) Surgery Rates

 

Follow-up: 24 hours, every 3 months up to 30 months, averaging 20.2 months in the steroid group and 21.5 months in the control group

 


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInformation currently not available

Allocation concealment (selection bias)Unclear riskInformation currently not available

Was the patient blinded to the intervention?High risk

Was the care provider blinded to the intervention?High risk

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Was the drop-out rate described and acceptable?High risk

Were all randomized participants analyzed in the group to which they were allocated?High risk

Selective reporting (reporting bias)High risk

Were the groups similar at baseline regarding the most important prognostic indicators?High risk

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?High risk

Was the timing of the outcome assessment similar in all groups?High risk

Eskola 1992

MethodsRandomized Controlled Trial


Participants39 subjects with an average of 6 years of pain, average age of 56.6 years of age, 20 males and 19 females

 

Setting: Orthopedic hospital in Finland


Interventions1)100IU Calcitonin injection every other day for 4 weeks. (n=20)

2) Placebo treatment (Miacalcic Sandoz 100IU) every other day for 4 weeks. (n=19)


Outcomes1) VAS

2) Treadmill Test

3) Coping with ADLs

4) Digitest Ergojump Contact Test

5) Blood Tests

 

Follow up: I, 3, 4, 6, and 12 months


NotesADLs = Activities of Daily Living, VAS = Visual Analogue Scale


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInformation currently not available

Allocation concealment (selection bias)Unclear riskInformation currently not available

Was the patient blinded to the intervention?High risk

Was the care provider blinded to the intervention?High risk

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Was the drop-out rate described and acceptable?Unclear riskInformation currently not available

Were all randomized participants analyzed in the group to which they were allocated?High risk

Selective reporting (reporting bias)Low risk

Were the groups similar at baseline regarding the most important prognostic indicators?Unclear riskInformation currently not available

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?Unclear riskInformation currently not available

Was the timing of the outcome assessment similar in all groups?High risk

Fukusaki 1988

MethodsRandomized Controlled Trial


Participants53 subjects, 38 males and 15 female. Group 1 averaged 70 years of age and 79 days of symptoms on average, group 2 averaged 69 years of age and an average of 82 days of symptoms, group 3 averaged 72 years of age and 94 days of symptoms on average

Setting: Anesthesia department in Japan


Interventions1) Epidural injection with 8 mL of saline, repeated twice in the first week. (n=16)

2) Epidural injection with 8 mL of 1% mepivacaine, repeated twice in the first week. (n=18)

3) Epidural injection with a mixture of 8 mL of 1% mepivacaine and 40 mg of methylprednisone, repeated twice in the first week. (n=19)


Outcomes1) Walking distance which was graded according to distance (Excellent, Good, or Poor)

 

Follow-up: 1 week, 1 month, 3 months


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInformation currently not available

Allocation concealment (selection bias)Unclear riskInformation currently not available

Was the patient blinded to the intervention?Unclear riskInformation currently not available

Was the care provider blinded to the intervention?Unclear riskInformation currently not available

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Was the drop-out rate described and acceptable?High risk

Were all randomized participants analyzed in the group to which they were allocated?High risk

Selective reporting (reporting bias)High risk

Were the groups similar at baseline regarding the most important prognostic indicators?High risk

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?High risk

Was the timing of the outcome assessment similar in all groups?High risk

Goren 2010

MethodsRandomized Controlled Trial


Participants45 subjects, 13 males, 32 females, average ages in groups of 57.4, 49.13, and 53.06. 7 subjects with pain duration of 3-6 months, 7 with pain duration of 6-12 months, and 31 with pain duration of greater than 12 months

Setting: Rehabilitation center in Turkey


Interventions1) Stretching and strengthening exercises for lumbar, abdominal, leg muscles as well as low-intensity cycling exercises were given as therapeutic exercises. Ultrasound was applied with 1mHz, 1.5W/cm2 intensity, in continuous mode on the back muscle for 10 minutes (n=17)

2) Same as group 1 with ultrasound on off-mode (n=17)

3) No exercise - no treatment (n=16)


Outcomes1) VAS (out of 10)

2) Treadmill test at 3 km/h for maximum of 15 minutes or 750m

3) ODI

4) Analgesic Consumption

5) Physiatrist Assessment

 

Follow-up: End of 3-week treatment period only


NotesVAS = Visual Analogue Scale, ODI = Oswestry Disability Index


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High risk

Allocation concealment (selection bias)High risk

Was the patient blinded to the intervention?Low risk

Was the care provider blinded to the intervention?Low risk

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Was the drop-out rate described and acceptable?High risk

Were all randomized participants analyzed in the group to which they were allocated?Low risk

Selective reporting (reporting bias)High risk

Were the groups similar at baseline regarding the most important prognostic indicators?High risk

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?Unclear riskInformation currently not available

Was the timing of the outcome assessment similar in all groups?High risk

Koc 2009

MethodsRandomized Controlled Trial


Participants29 subjects, 21 male, 8 female, average ages of 62.6, 61.1, and 53.1 years in the three groups, average pain duration of 5.7 years, 5.0 years, and 5.7 years in the three groups

Setting: Medical school department of physical medicine and rehabilitation in Turkey


Interventions1) Conservative inpatient physical therapy program 5 days a week for 2 weeks. PT included applications of ultrasound 1.5 W/cm2 for 10min, hot pack for 20min, and TENS for 20min to the lumbar region (n=13)

2) Lumbar epidural steroid injections, 10 mL of solution containing 60mg of triamcinolon acetonide (1.5 mL), 15 mg of 0.5% bupivacain hydrochloride (3 mL), and 5.5 mL of physiologic saline (0.9%NaCl) was injected in 3.5 minutes (n=10)

3) Control group (n=10)

 

All patients included were trained to pursue a home-based therapeutic exercise program performed twice daily for a period of 6 months, and oral diclofenac sodium 75mg was administered to all patients twice daily for 2 weeks


Outcomes1) VAS

2) Treadmill Walk Test

3) Nottingham Health Profile

4) RMDI

5) Functional testing including finger to floor distance, sit-to-stand, and a weight carrying test

 

Follow-up: 2 weeks, 1, 3, and 6 months


NotesODI = Oswestry Disability Index, RMDI = Roland Moris Disability Index, VAS = Visual Analogue Scale


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInformation currently not available

Allocation concealment (selection bias)Unclear riskInformation currently not available

Was the patient blinded to the intervention?Low risk

Was the care provider blinded to the intervention?Low risk

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Was the drop-out rate described and acceptable?High risk

Were all randomized participants analyzed in the group to which they were allocated?High risk

Selective reporting (reporting bias)Low risk

Were the groups similar at baseline regarding the most important prognostic indicators?High risk

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?Unclear riskInformation currently not available

Was the timing of the outcome assessment similar in all groups?High risk

Malmivaara 2007

MethodsRandomized Controlled Trial


Participants94 subjects, 22% of surgical subjects were male, 45% of non-operative subjects were male. Nonoperative group had average age of 62.9 years, surgical group had average age of 63.9 years. Surgical group averaged 14 years since onset of symptoms, non-surgical group average 16 years since onset of symptoms.  Minimum of 6 months of symptoms for study inclusion

Setting: Research Center in Finland


Interventions1) Segmental decompressive surgery with facetectomy (n=50)

2) Non-operative treatment – NSAIDS when indicated and seen one to three times by a physiotherapist, in addition to the standard visit at each follow-up. The physiotherapist gave all patients educational brochure. The patients were encouraged to use their back in a normal way. Pain-relieving body postures were taught as well as basic ergonomics related to lifting and carrying. Individually structured programs included trunk muscle endurance and stretching-type exercises. Additional individual physiotherapy consisting of passive treatment methods (such as ultrasound and transcutaneous nerve stimulation) (n=44)

The patients in the surgical group also received the brochure and the instructions described above


Outcomes1) 11-point numerical pain rating scale for back and leg pain

2) Walking ability (distance without a break) also via treadmill test

3) General health status on a 5-point scale (Very Good, Quite Good, Average, Quite Poor, or Very Poor)

4) ODI

5) Ability to complete certain ADL without difficulty, some difficulty, marked difficulties or not at all

6) Radiographic examination

Follow-up: 6 months, 1, 2 and 6 years


NotesADLs = Activities of Daily Living, ODI = Oswestry Disability Index


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High risk

Allocation concealment (selection bias)High risk

Was the patient blinded to the intervention?Low risk

Was the care provider blinded to the intervention?Low risk

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Was the drop-out rate described and acceptable?High risk

Were all randomized participants analyzed in the group to which they were allocated?High risk

Selective reporting (reporting bias)High risk

Were the groups similar at baseline regarding the most important prognostic indicators?High risk

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?Unclear riskInformation currently not available

Was the timing of the outcome assessment similar in all groups?High risk

Matsudaira 2009

MethodsRandomized Controlled Trial


Participants79 subjects, 24 males and 24  females, with an average age of 69.6 years in the Limaprost group and 72.2 in the etodolac group

Setting: Orthopedic surgery in a medical faculty in Japan


Interventions1) Oral prostaglandin E1 derivative (15 g Limaprost) three times daily for eight weeks (n=39)

2) 400 mg of etodolac (NSAID) twice daily for eight weeks (n=40)


Outcomes1) SF-36

2) Verbal Pain Rating Scales

3) Walking Distance

4) LBP Severity

5) Leg Pain Severity

6) Leg Numbness Severity

7) Treatment Satisfaction

 

Follow-up: 8 weeks


NotesLBP = Low Back Pain


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High risk

Allocation concealment (selection bias)High risk

Was the patient blinded to the intervention?Unclear riskInformation currently not available

Was the care provider blinded to the intervention?Unclear riskInformation currently not available

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Was the drop-out rate described and acceptable?High risk

Were all randomized participants analyzed in the group to which they were allocated?High risk

Selective reporting (reporting bias)Unclear riskInformation currently not available

Were the groups similar at baseline regarding the most important prognostic indicators?High risk

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?Unclear riskInformation currently not available

Was the timing of the outcome assessment similar in all groups?High risk

Podichetty 2004

MethodsRandomized Controlled Trial


Participants55 subjects with an average age of 68.5 years and an average of 36.2 weeks of the condition in the intervention group and 29.8 weeks in the placebo group, 33 males and 22 females

Setting: Spinal center in the United States


Interventions1) 400 IU intranasal calcitonin daily for 6 weeks followed by open label 6-week extension (n=36)

2) Placebo nasal spray daily for 6 weeks, followed by open label 6-week extension, during which all patients received 400IU calcitonin (n=19)


Outcomes1) VAS

2) Walking Capacity (time and distance to stopping)

3) ODI

4) Stenosis Specific Questionnaire

5) Satisfaction with pain levels, functional status, and treatment received

6) SF-36

7) Symptom Diary

Follow-up: 12 weeks


NotesVAS = Visual Analogue, ODI = Oswestry Disability Index


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInformation currently not available

Allocation concealment (selection bias)Unclear riskInformation currently not available

Was the patient blinded to the intervention?High risk

Was the care provider blinded to the intervention?High risk

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Was the drop-out rate described and acceptable?Low risk

Were all randomized participants analyzed in the group to which they were allocated?High risk

Selective reporting (reporting bias)Low risk

Were the groups similar at baseline regarding the most important prognostic indicators?High risk

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?Unclear riskInformation currently not available

Was the timing of the outcome assessment similar in all groups?High risk

Porter 1983

MethodsRandomized Controlled Trial


Participants41 subjects with 10 in a double blind RCT crossover, 37 males and 4 females with ages between 41 and 67 years

Setting: Infirmary in England


Interventions1) 100 IU salmon calcitonin injection four times per week, sometimes with Maxalon for nausea (n=5)

2) Matching placebo (n=5)


Outcomes1) Walking chart and ability to walk more than 1 mile

2) ODI

Follow-up: 10 weeks


NotesOnly responders randomized, ODI = Oswestry Disability Index


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInformation currently not available

Allocation concealment (selection bias)Unclear riskInformation currently not available

Was the patient blinded to the intervention?Low risk

Was the care provider blinded to the intervention?Unclear riskInformation currently not available

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInformation currently not available

Was the drop-out rate described and acceptable?High risk

Were all randomized participants analyzed in the group to which they were allocated?High risk

Selective reporting (reporting bias)Unclear riskInformation currently not available

Were the groups similar at baseline regarding the most important prognostic indicators?Low risk

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?High risk

Was the timing of the outcome assessment similar in all groups?High risk

Porter 1988

MethodsRandomized Controlled Trial


Participants42 subjects, 35 male, 7 female, average of 53.6 years in 20 subjects and 56.7 years in 22 subjects, median duration of back pain reported was 11 years for 19 subjects, and 14 years for 22 subjects. Median duration of claudication was 1.25 years for 20 subjects and 4.5 years for 22 subjects

Setting: Infirmary in England


Interventions1) 100 IU of salmon calcitonin injected subcutaneously four times per week for eight weeks (n=20)

2) 1 mL of saline injected four times per week for eight weeks (n=22)


Outcomes1) VAS

2) Claudication threshold and tolerance for walking at constant speed with verbal description of walking pain on a 5-point pain rating scale

3) 3 level mobility assessment

4) Analgesic requirements

5) 3 level sleep disturbance

6) Treatment success defined as 100% improvement in walking distance and able to walk 800m

Follow-up: 4 and 8 weeks


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInformation currently not available

Allocation concealment (selection bias)Unclear riskInformation currently not available

Was the patient blinded to the intervention?High risk

Was the care provider blinded to the intervention?Unclear riskInformation currently not available

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInformation currently not available

Was the drop-out rate described and acceptable?Low risk

Were all randomized participants analyzed in the group to which they were allocated?High risk

Selective reporting (reporting bias)High risk

Were the groups similar at baseline regarding the most important prognostic indicators?Unclear riskInformation currently not available

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?Unclear riskInformation currently not available

Was the timing of the outcome assessment similar in all groups?High risk

Pua 2007

MethodsRandomized Controlled Trial


Participants68 subjects, 35 males, 33 females, average age of 58 years, 12 week median pain duration

Setting: Hospital in Singapore


Interventions1) Unweighted treadmill training - Weeks 1 and 2, participants walked with a relatively pain-free gait which translated to 30–40% of body weight. In Weeks 3 to 6, participants were encouraged to walk at a moderate intensity. The duration of each treadmill session was limited by participant tolerance or to a maximum of 30 minutes.  Two times per week for 6 weeks = 12 sessions (n=33)

2) Cycling on upright bicycle - During Weeks 1 and 2, participants cycled at their comfortable pace at 50 to 60 rpm. Participants were instructed to assume a flexed posture. In Weeks 3 to 6, participants were encouraged to exercise at a moderate intensity and the duration of each cycling session was limited by participant tolerance or to a maximum of 30 minutes. Two times per week for 6 weeks for 12 sessions (n=35)


Outcomes1) VAS for pain over past week

2) Patient perceived benefit on a 6-point scale

3) ODI

4) RMDI

5) Walking Ability

 

Follow-up: 3 and 6 weeks


NotesODI = Oswestry Disability Index, RMDI = Roland Moris Disability Index, VAS = Visual Analogue Scale


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High risk

Allocation concealment (selection bias)High risk

Was the patient blinded to the intervention?Low risk

Was the care provider blinded to the intervention?Low risk

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Was the drop-out rate described and acceptable?Low risk

Were all randomized participants analyzed in the group to which they were allocated?High risk

Selective reporting (reporting bias)High risk

Were the groups similar at baseline regarding the most important prognostic indicators?High risk

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?Low risk

Was the timing of the outcome assessment similar in all groups?High risk

Sahin 2009

MethodsRandomized Controlled Trial


Participants45 subjects 31 males and 14 females, average ages of 57.65 years in the calcitonin group and 54.45 years in the paracematol group

Setting: Physical and Rehabilitation Medicine Department in Turkey


Interventions1) 200 IU intranasal calcitonin daily for 8 weeks (n=23)

2) Up to 1500mg of paracematol daily for 8 weeks (n=22)

 

Both groups took part in a physical therapy and exercise program five times per week for 15 sessions


Outcomes1) VAS

2) Walking Capacity

3) RMDI

4) Ranges of Motion

 

Follow up: 8 weeks


NotesRMDI = Roland Moris Disability Index, VAS = Visual Analogue Scale


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInformation currently not available

Allocation concealment (selection bias)Unclear riskInformation currently not available

Was the patient blinded to the intervention?Low risk

Was the care provider blinded to the intervention?Low risk

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Was the drop-out rate described and acceptable?Low risk

Were all randomized participants analyzed in the group to which they were allocated?Unclear riskInformation currently not available

Selective reporting (reporting bias)High risk

Were the groups similar at baseline regarding the most important prognostic indicators?High risk

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?Unclear riskInformation currently not available

Was the timing of the outcome assessment similar in all groups?High risk

Tafazal 2007

MethodsRandomized Controlled Trial


Participants40 subjects, 30 males, 10 females, average of 67 years in the intervention group and 70.2 years in the placebo group, average of 38.7 months with symptoms in the calcitonin group and 30.9 months in the placebo group

Setting: University hospital in England


Interventions1) Placebo nasal spray NaCl for four weeks (n=20)

2) 200 IU nasal salmon calcitonin for 4 weeks (n=20)


Outcomes1) VAS

2) Shuttle Walking Test

3) 4 point subjective outcome of overall assessment (Excellent, Good, Fair, Poor)

4) ODI

5) Modified Somatic Perception Questionnaire

6) Modified Zung Depression Score

 

Follow-up: Baseline, 4, 10, 16 weeks


NotesODI = Oswestry Disability Index, VAS = Visual Analogue Scale


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInformation currently not available

Allocation concealment (selection bias)Unclear riskInformation currently not available

Was the patient blinded to the intervention?High risk

Was the care provider blinded to the intervention?High risk

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Was the drop-out rate described and acceptable?High risk

Were all randomized participants analyzed in the group to which they were allocated?High risk

Selective reporting (reporting bias)High risk

Were the groups similar at baseline regarding the most important prognostic indicators?Low risk

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?Unclear riskInformation currently not available

Was the timing of the outcome assessment similar in all groups?High risk

Waikakul 2000

MethodsRandomized Controlled Trial


Participants152 subjects, 68 males and 84 females with an average age of 66.8 years. 44 of the subjects had symptoms for less than one month, 98 had symptoms for more than one month

Setting: Hospital in Thailand


Interventions1) Conservative treatment consisting of education, activity modification, exercise and physical therapy. NSAIDs, muscle relaxants, and analgesics as necessary. Vitamin B1, B6, and B12 three times per day (n=82)

2) Conservative treatment plus methylcobalamin (Methlcobalin ESAI), 1.5mg per day in 3 divided doses after meals for 6 months (n=70)


Outcomes1) Presence of pain on spinal motion

2) Claudication distance

3) Medication intake (NSAIDs, muscle relaxants, and steroids)

 

Follow-up: every month for two years


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk

Allocation concealment (selection bias)Unclear riskInformation currently not available

Was the patient blinded to the intervention?Low risk

Was the care provider blinded to the intervention?Low risk

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Was the drop-out rate described and acceptable?High risk

Were all randomized participants analyzed in the group to which they were allocated?High risk

Selective reporting (reporting bias)Unclear riskInformation currently not available

Were the groups similar at baseline regarding the most important prognostic indicators?High risk

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?Unclear riskInformation currently not available

Was the timing of the outcome assessment similar in all groups?High risk

Weinstein 2007

MethodsRandomized Controlled Trial


ParticipantsSubjects with image-confirmed degenerative spondylolisthesis: 304 subjects in clinical trial, 303 in the observational cohort, 31% male in the surgical group, 33% male in the surgical group. Average age of 64.7 years in the surgical group and 68.2 years in the non-surgical group. Subjects had symptoms for at least 12 weeks

Setting: Multicentred orthopedic departments in the United States


Interventions1) Assigned to surgery (standard laminectomy with or without fusion) (n=159)

2) Assigned to non-surgical treatment – usual non-operative care (n=145)

3) Chose surgery (n=173)

4) Chose non-surgical treatment (n=130)


Outcomes1) SF-36 Bodily Pain

2) SF-36 Bodily Function

3) Low Back Pain Bothersomeness Scale

4) Leg Pain Bothersomeness Scale

5) ODI

6) Subjective self-reported improvement, satisfaction with current symptoms and care

7) Stenosis Bothersomeness Index

Follow-up: 6 w, 3 and 6 mo, 1, 2 and 4 yrs


NotesODI = Oswestry Disability Index


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High risk

Allocation concealment (selection bias)High risk

Was the patient blinded to the intervention?Low risk

Was the care provider blinded to the intervention?Low risk

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Was the drop-out rate described and acceptable?High risk

Were all randomized participants analyzed in the group to which they were allocated?High risk

Selective reporting (reporting bias)High risk

Were the groups similar at baseline regarding the most important prognostic indicators?Unclear riskInformation currently not available

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?Low risk

Was the timing of the outcome assessment similar in all groups?High risk

Weinstein 2008

MethodsRandomized Clinical Trial


Participants289 in the RCT, 365 in the observational cohort. 62% male in the surgical groups, 59% male in the non-surgical groups. Average age of 63.8 in the surgical group, 66.1 in the non-surgical group. 60% in the surgical group and 55% in the non-surgical group had symptoms for over 6 months

Setting: Multicentered - orthopedic departments in the United States


Interventions1) Assigned to surgery – standard laminectomy with or without fusion (n=138)

2) Assigned to non-surgical treatment - usual non-operative care - recommended to include at least active physical therapy, education or counseling with home exercise instruction, and the administration of NSAIDs, if tolerated (n=151)

3) Chose surgery (n=219)

4) Chose non-surgical treatment (n=146)


Outcomes1) SF-36 Bodily Pain

2) SF-36 Bodily Function

3) Low Back Pain Bothersomeness Scale

4) Leg Pain Bothersomeness Scale

5) ODI

6) Subjective self-reported improvement, satisfaction with current symptoms and care

7) Stenosis Bothersomeness Index

 

Follow-up: 6 weeks, 3 and 6 months, 1, 2 and 4 years


NotesODI = Oswestry Disability Index


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High risk

Allocation concealment (selection bias)High risk

Was the patient blinded to the intervention?Low risk

Was the care provider blinded to the intervention?Low risk

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Was the drop-out rate described and acceptable?Low risk

Were all randomized participants analyzed in the group to which they were allocated?High risk

Selective reporting (reporting bias)High risk

Were the groups similar at baseline regarding the most important prognostic indicators?Unclear riskInformation currently not available

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?Low risk

Was the timing of the outcome assessment similar in all groups?High risk

Whitman 2006

MethodsRandomized Clinical Trial


Participants58 subjects, 31 males, 27 female, 29 (group 1) with an average age of 70 years, 29 (group 2) with an average age of 68.9, median low back pain duration of 108 months in Group 1 (n=29) and 60 months in Group 2 (n=29), lower extremity median pain duration of 48 months in Group 1 (n=29) and 24 months in Group 2 (n=29)

Setting: University in the United States


Interventions1) Flexion Exercise and Walking Group – 45-60 minutes twice per week for 6 weeks. - Lumbar flexion exercises along with performance of a progressive level self pace treadmill walking program, and subtherapeutic ultrasound. The duration of each treadmill session was based on patient’s tolerance on that specific day and could extend up to 45 minutes (n=29)

2) Manual Therapy, Exercise and Walking Group - 45-60 minutes twice per week for 6 weeks - Manual physical therapy (thrust and non-thrust) to the thoracic and lumbar spine, pelvis, and lower extremities and specific exercises at discretion based on the underlying impairments. Patients received specific exercises to address impairments in mobility, strength, and/or coordination. Exercises were performed in the clinic and as part of a home exercise program. Patients also underwent a body-weight supported treadmill ambulation program using a cable and trunk harness system to unload a specific amount of weight from the patient while the patient walks as comfortably as possible on a treadmill (n=29)


Outcomes1) Global Rating of Change (15 point scale)

2) Numerical Pain Rating Scale for lower limb

3) Walking Tolerance test

4) ODI

5) Medication consumption

6) Satisfaction subscale of the Spinal Stenosis Scale

7) Additional use of healthcare resources

 

Follow-up: 6 weeks, 1 year, long-term mail survey (averaging 29 months)


NotesNPRS = Numerical Pain Rating Scale, ODI = Oswestry Disability Index


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High risk

Allocation concealment (selection bias)Unclear riskInformation currently not available

Was the patient blinded to the intervention?Low risk

Was the care provider blinded to the intervention?Low risk

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Was the drop-out rate described and acceptable?High risk

Were all randomized participants analyzed in the group to which they were allocated?High risk

Selective reporting (reporting bias)High risk

Were the groups similar at baseline regarding the most important prognostic indicators?High risk

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?Unclear riskInformation currently not available

Was the timing of the outcome assessment similar in all groups?High risk

Yaski 2007

MethodsRandomized Clinical Trial


Participants55 subjects, 22 males, 33 females, average age of 50.8 years

Setting: Hospital department of physical medicine and rehabilitation in Turkey


Interventions1) 900 mg of gabapentin per day increased weekly by 300 mg to a maximum of 2400 mg (n=28)

2) Placebo (n=27)

 

Both groups received physical therapy exercises, a lumbosacral corset with steel bracing and NSAID treatments


Outcomes1) VAS – low back and leg pain during movement

2) Walking Distance

3) Presence or absence of motor and/or sensory deficits

 

Follow-up: 15 days, 1, 2, 3, 4 months


NotesVAS = Visual Analogue Scale


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInformation currently not available

Allocation concealment (selection bias)Unclear riskInformation currently not available

Was the patient blinded to the intervention?Low risk

Was the care provider blinded to the intervention?Low risk

Blinding of outcome assessment (detection bias)
All outcomes
Low risk

Was the drop-out rate described and acceptable?Unclear riskInformation currently not available

Were all randomized participants analyzed in the group to which they were allocated?High risk

Selective reporting (reporting bias)High risk

Were the groups similar at baseline regarding the most important prognostic indicators?Unclear riskInformation currently not available

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?Unclear riskInformation currently not available

Was the timing of the outcome assessment similar in all groups?High risk

Zahaar 1991

MethodsRandomized Clinical Trial


Participants30 subjects, 37 male and 26 female. Steroid group averaged 46.5 years of age and 36.6 months of symptoms, control group averaged 49 years of age and 29.4 months of symptoms

Setting: Medical facility in Egypt


Interventions1) Steroid injection - 5mL of hydrocortisone acetate suspension, 2x2mL carbocaine, 4% volume completed with sterile saline to 30mL (n=18)

2) Control - 2x2mL of carbocaine, 4% injected into epidural space. Volume completed with sterile saline to 30mL (n=12)


Outcomes1) Subjective percentage of improvement where 75% or more was deemed successful and surgery after injection was considered a failure

 

Follow-up: 24 hours, then every three months up to 36 months averaging 20.2 months in the steroid group and 21.5 months control group


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInformation currently not available

Allocation concealment (selection bias)Unclear riskInformation currently not available

Was the patient blinded to the intervention?High risk

Was the care provider blinded to the intervention?Unclear riskInformation currently not available

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Was the drop-out rate described and acceptable?High risk

Were all randomized participants analyzed in the group to which they were allocated?High risk

Selective reporting (reporting bias)High risk

Were the groups similar at baseline regarding the most important prognostic indicators?High risk

Were co-interventions avoided or similar?Low risk

Was the compliance acceptable in all groups?Unclear riskInformation currently not available

Was the timing of the outcome assessment similar in all groups?Low risk

Zucherman 2004

MethodsRandomized Clinical Trial


Participants191 subjects, 57% male and 43% female in the X STOP group. 52% male and 48% female in the non-operative group. Average age of 70 years in the X STOP group and 69.1 years in the non-operative group. Average of 3.5 years symptom duration in the X STOP group and 4.7 years in the non-operative group.

Setting: Spine center in the United States


Interventions1)  X STOP Interspinous Process Decompression System (n=100)

2) Non-operative treatment – subjects received an epidural steroid injection on enrolment and were eligible for additional injections as needed, as well as NSAIDS, analgesic agents, and physical therapy. Physical therapy consisted of education on back care and modalities such as ice packs, heat packs, massage, stabilization exercises, and pool therapy. Braces such as abdominal binders and corsets were permitted, but body jackets and chair back braces were not (n=91)


Outcomes1) SF-36

2) ZCQ

3) Worker’s Compensation Claims

4) ODI

5) Radiographic Changes

  

Follow-up:

Surgery: 7 (2 years)

Control: 19 (2 years)


NotesODI, ZCQ = Zurich Claudication Questionnaire


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInformation currently not available

Allocation concealment (selection bias)High risk

Was the patient blinded to the intervention?Low risk

Was the care provider blinded to the intervention?Low risk

Blinding of outcome assessment (detection bias)
All outcomes
High risk

Was the drop-out rate described and acceptable?High risk

Were all randomized participants analyzed in the group to which they were allocated?High risk

Selective reporting (reporting bias)High risk

Were the groups similar at baseline regarding the most important prognostic indicators?High risk

Were co-interventions avoided or similar?Unclear riskInformation currently not available

Was the compliance acceptable in all groups?High risk

Was the timing of the outcome assessment similar in all groups?High risk

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Akyol 2009Not published in English

Canovas 2009Not published in English

Comer 2010No imaging confirmation requirement for inclusion

Ghosh 1981Not neurogenic claudication

Huda 2010No imaging confirmation requirement for inclusion

Khoromi 2007aNot neurogenic claudication but radiculopathy as inclusion criterion

Khoromi 2007bNot neurogenic claudication but radiculopathy as inclusion criterion

Lee 2003Patients with leg pain were excluded

Levendogluo 2009Not an RCT

Makki 2010Not neurogenic claudication but radiculopathy as inclusion criterion

Manchikanti 2008Neurogenic claudication not explicitiy stated as inclusion criterion

Mariconda 2002Not neurogenic claudication but radiculopathy as inclusion criterion

Mathews 1975Not neurogenic claudication but sciatica or radiculopathy as inclusion criterion

Ng 2005Mixed population not analysed separately

Oguz 2007Not an RCT

Owlia 2007No data on number of patients with lumbar spinal stenosis, patients did not explicitly have neurogenic claudication, subacute population

Paker 2005Not an RCT

Price 2000Neurogenic claudication was not an inclusion criterion

Price 2005Not neurogenic claudication but radiculopathy as inclusion criterion

Riew 2000Mixed population, neurogenic claudication was not an inclusion criterion

Riew 2008Mixed population, neurogenic claudication was not an inclusion criterion

Sell 2006Duplicate of accepted study (see Tafazal 2007)

Simopoulos 2003Not neurogenic claudication but radiculopathy as inclusion criterion

Thackeray 2009Not neurogenic claudication but radiculopathy as inclusion criterion

Wiilson-MacDonald 2005Neurogenic claudication was not an explicit requirement, patients had nerve root pain, patients were subacute

Wu 2003Not published in English

 
Comparison 1. Direct Decompression ± fusion versus multimodal nonoperative care for Oswestry Disability Index

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

 1 Oswestry Disability Index2Mean Difference (IV, Random, 95% CI)Subtotals only

    1.1 6 Months
2349Mean Difference (IV, Random, 95% CI)-3.66 [-10.12, 2.80]

    1.2 12 Months
2340Mean Difference (IV, Random, 95% CI)-6.17 [-15.02, 2.67]

    1.3 24 Months
2315Mean Difference (IV, Random, 95% CI)-4.43 [-7.91, -0.96]

 
Table 1. Nonoperative interventions for lumbar spinal stenosis with neurogenic claudication: a summary of GRADE assessment and outcomes

Comparisons and trialsRisk of biasGRADE assessment and outcomes/measures (walking ability, pain, function, and quality of life) at each follow-up point

ConsistencyDirectnessPrecisionSelective

reporting
ImmediateShort-termIntermediateLong-termQuality of the evidence

Calcitonin

Calcitonin injection versus placebo injection

Eskola 1992High

High
No

No
Yes

Yes
No

No
Yes

Yes
 = TWT

= VAS
= TWT

= VAS
= TWT

= VAS
+000

+000

Porter 1983HighNoYesNoYes ? distance walked? distance walked +000

Porter 1988High

High
No

No
Yes

Yes
No

No
Yes

Yes
 = distance walked

= VAS
  +000

+000

Calcitonin nasal spray versus placebo nasal spray

Podichetty 2004High

High

High

High
No

No

No

No
Yes
Yes

Yes

Yes
No

No

No

No
Yes = distance walked

= time walked

= SF-36

= VAS
  +000

+000

+000

+000

Tafazal 2007High

High

High

High

High
No

No

No

No

No
Yes

Yes

Yes

Yes

Yes
No

No

No

No

No
  = Shuttle walk

= VAS leg

= VAS back

= ODI

= global
  +000

+000

+000

+000

+000

Calcitonin nasal spray plus physical therapy versus paracetamol plus physical therapy

Sahin 2009High

High

High
No

No

No
Yes

Yes

Yes
No

No

No
  = distance walked

= VAS

= RMDI
  +000

+000

+000

Oral medication

Oral prostaglandin versus etodolac (NSAID)

Matsudaira 2009

 
Low

Low

Low

Low

Low
No

No

No

No

No
Yes

Yes

Yes

Yes

Yes
No

No

No

No

No
 Yes > distance walked

? SF-36

= LBP

> Leg pain

> global
  ++00

+000

++00

++00

++00

Methylocobalamin (vitamin B12) plus conservative care versus conservative care

Waikakul 2000HighNoYesNoYes> distance walked> distance walked+000

Gabapentin versus placebo

Yaski 2007

 
High

High

High
No

No

No
Yes

Yes

Yes
No

No

No
   > distance walked

= VAS (1-2 months)

> VAS (3 months)
> distance walked

> VAS
+000

+000

+000

Physical therapy

Exercise plus ultrasound versus exercise plus sham ultrasound

Goren 2010Low

Low

Low

Low
No

No

No

No
Yes

Yes

Yes

Yes
No

No

No

No
  = TWT

= VAS back

= VAS leg

= ODI
  ++00

++00

++00

++00

Exercise plus ultrasound versus no treatment

Goren 2010Low

Low

Low

Low
No

No

No

No
Yes

Yes

Yes

Yes
No

No

No

No
  = TWT

= VAS back

> VAS leg

> ODI
  ++00

++00

++00

++00

Exercise plus sham ultrasound versus no treatment

Goren 2010Low

Low

Low

Low
No

No

No

No
Yes

Yes

Yes

Yes
No

No

No

No
  = TWT

= VAS back

> VAS leg

> ODI
  ++00

++00

++00

++00

Inpatient physical therapy versus home exercise program plus oral diclofenac

Koc 2009High

High

High

High
No

No

No

No
Yes

Yes

Yes

Yes
No

No

No

No
Yes = TWT

> VAS

> RMDI

> NHP
= TWT

= VAS

= RMDI

= NHP
 +000

+000

+000

+000

Unweighted treadmill walking plus exercise versus cycling plus exercise

Pua 2007Low

Low

Low

Low

Low
No

No

No

No

No
Yes

Yes

Yes

Yes

Yes
No

No

No

No

No
  = distance walked

= ODI

= RMDI

= VAS

= global
  ++00

++00

++00

++00

++00

Manual therapy, exercise and unweighted treadmill versus flexion exercise, walking and sham ultrasound

Whitman 2006High

High

High

High
No

No

No

No
Yes

Yes

Yes

Yes
No

No

No

No
  = TWT

> global

= ODI

= NPRS
 = global+000

+000

+000

+000

Epidural injection

Translaminar epidural steroid injections versus placebo injections

Cuckler 1985HighNoYesNo= global=global+000

Translaminar epidural steroids plus epidural block versus placebo injections

Fukusaki 1988HighNoYesNo > distance walked= distance walked  +000

Translaminar epidural steroids plus epidural block versus epidural block injections

Fukusaki 1988HighNoYesNo = distance walked= distance walked  +000

Translaminar epidural block versus placebo

Fukusaki 1988HighNoYesNo > distance walked= distance walked  +000

Intralaminar epidural steroid plus epidural block versus home exercise program plus oral diclofenac

Koc 2009High

High

High

High
No

No

No

No
Yes

Yes

Yes

Yes
No

No

No

No
Yes

Yes

Yes

Yes
 = TWT

> VAS

> RMDI

> NHP
= TWT

= VAS

= RMDI

= HNP
 +000

+000

+000

+000

Intralaminar epidural steroid plus epidural block versus inpatient physical therapy

Koc 2009High

High

High

High
No

No

No

No
Yes

Yes

Yes

Yes
No

No

No

No
Yes

Yes

Yes

Yes
 = TWT

> VAS

> RMDI

> NHP
= TWT

= VAS

= RMDI

= HNP
 +000

+000

+000

+000

Caudal epidural steroids versus placebo injections

Zahaar 1991HighNoYesNo = global  = global+000

Multimodal nonoperative treatment

Indirect decompression using interspinous spacer (X-Stop) versus multimodal nonoperative care for degenerative spondylolisthesis

Zucherman 2004, Anderson

2006
HighNoYesNoSR (short &

intermediate)
 > ZCQ> ZCQ> ZCQ+000

Indirect decompression using interspinous spacer (X_Stop) versus multimodal nonoperative care

Zucherman 2004, 2005, Hsu 2006HighNo

No
Yes

Yes
No

No
SR

SR
 > ZCQ

> SF-36
> ZCQ

> SF-36
> ZCQ

> SF-36
+000

+000

Direct decompression ± fusion versus multimodal nonoperative care for degenerative spondylolisthesis

Weinstein 2007High

High

High

High

High
No

No

No

No

No
Yes

Yes

Yes

Yes

Yes
No

No

No

No

No
  = SF-36

= ODI

= LBPBS

= LPBI

= SBS
= SF-36

= ODI

= LBPBS

= LPBI

= SBS
= SF-36

= ODI

= LBPBS

= LPBI

= SBS
+000

+000

+000

+000

+000

Direct decompression ± fusion versus multimodal nonoperative care

Amundsen 2000High

High
No

No
Yes

Yes
No

No
  ?* pain severity?* global?* pain severity

? global
+000

+000

Malmivaara 2007Low

Low

Low

Low

Low

Low
No

No

No

No

No

No
Yes

Yes

Yes

Yes

Yes

Yes
No

No

No

No

No

No
  = TWT

= SW

> VAS leg walk

> VAS leg

> VAS  LB

ODI (see Figure 4)
= TWT

= SW

> VAS leg walk

> VAS leg

> VAS  LB

ODI (see Figure 4)
++00

++00

++00

++00

++00

+000

Weinstein 2008High

High

High

High

High

High
No

No

No

No

No

No
Yes

Yes

Yes

Yes

Yes

Yes
No

No

No

No

No

No
  = SF-36 BP

= SF-36 PF

= LBPBS

= LPBI

= SBS

= ODI
= SF-36 BP

= SF-36 PF

= LBPBS

= LPBI

= SBS

ODI (see Figure 4)
> SF-36 BP**

= SF-36  PF

= LBPBS

= LPBI

= SBS

ODI (Figure 4)
+000

+000

+000

+000

+000

+000

 Follow-up points: Immediate = up to 1 week, short-term = >1 week - 3 months, intermediate = 3 months - 1 year, long-term = > 1 year
> statistically significant favouring intervention (first comparison), < statistically significant favouring control (second comparison), = no statistically significant difference between intervention and control groups
TWT = Treadmill Walking Test, VAS = Visual Analog Scale for Pain Intensity, RMDI = Roland-Morris Back Disability Index, NHP = Nottingham Health Profile, Global = Patient Perceived Improvement, SR = Selective Reporting, ODI = Oswestry Back Disability Index, ? = insufficient data, LBP = Low back Pain Severity Scale, Leg pain = Leg Pain Severity Scale, ? SF-36 = No data on overall score, improvement in some subscales, NPRS = Numeric Pain Rating Scale, SF-36 BP = SF-36 Bodily Pain Subscale, SF-36- PF = SF-36 Physical Function Subscale, LBPBS - Low Back Pain Bothersome Scale, LPBI = Leg Pain Bothersome Index, SBS - Stenosis Bothersome Scale, SW = Subjective Walking, VAS leg = Visual Analog Scale for Leg Pain, VAS LB = Visual Analog Scale for Low Back Pain, VAS leg walking = Visual Analog Scale for Leg pain while walking, ?* = no between group statistical comparisons, ** = SF-36 BP significantly better at 2 years but not 4 years.
GRADE evidence: +000 = Very low quality evidence, ++00 = Low quality evidence, +++0 = Moderate quality evidence, ++++ = High quality evidence