EFFECTIVENESS OF CONSERVATIVE NONPHARMACOLOGIC THERAPIES FOR PAIN, DISABILITY, PHYSICAL CAPACITY, AND PHYSICAL ACTIVITY BEHAVIOR IN PATIENTS WITH DEGENERATIVE LUMBAR SPINAL STENOSIS: A SYSTEMATIC REVIEW AND META-ANALYSIS
 
   

Effectiveness of Conservative Nonpharmacologic Therapies
for Pain, Disability, Physical Capacity, and Physical
Activity Behavior in Patients With Degenerative
Lumbar Spinal Stenosis: A Systematic
Review and Meta-Analysis

This section is compiled by Frank M. Painter, D.C.
Send all comments or additions to:
    Frankp@chiro.org
 
   

FROM:   Arch Phys Med Rehabil 2021 (Nov); 102 (11): 2247–2260 ~ FULL TEXT

Samantha Jacobi, BScKin, Amber Beynon, BSc, Stephan U. Dombrowski, PhD, Niels Wedderkopp, MD, PhD, et al.

Faculty of Kinesiology,
University of New Brunswick,
Fredericton, New Brunswick, Canada


Objective:   To investigate the effectiveness of conservative nonpharmacologic therapies on pain, disability, physical capacity, and physical activity outcomes in patients with degenerative lumbar spinal stenosis (LSS).

Data sources:   Systematic search of MEDLINE, EMBASE, CENTRAL, and PsycINFO from inception to November 4, 2019, without language restrictions.

Study selection:   Pairs of review authors independently identified randomized controlled trials published in peer-reviewed scientific journals reporting on the effects of rehabilitation interventions on pain intensity (back or leg), disability, symptom severity, physical capacity, physical activity behavior, or adverse events (secondary outcome) in adults with LSS. The search identified 1718 records; data from 21 reports of 19 trials (1432 patients) were included.

Data extraction:   Review author pairs independently extracted data and assessed included studies. We assessed risk of bias with the Cochrane tool, and overall study quality with the Grading of Recommendations Assessment, Development and Evaluation classification.

Data synthesis:   We pooled data using random-effects meta-analyses; treatment effects were reported as mean differences (MD) and 95% confidence intervals (CI). Directed exercise and manual therapy was superior to self-directed or group exercise for improving short-term walking capacity (MD, 293.3 m; 95% CI, 61.7–524.9 m; low-quality evidence), back pain (MD, –1.1; 95% CI, –1.8 to –0.4; moderate quality evidence), leg pain (MD, –.9; 95% CI, –0.2 to –1.5; moderate-quality evidence), and symptom severity (MD, –0.3; 95% CI, –0.4 to –0.2; low quality evidence). There is very low quality evidence that rehabilitation is no better than surgery at improving intermediate- or long-term disability. Single trials provided conflicting evidence of effectiveness for a variety of therapies.

Conclusions:   For patients with LSS, there is low- to moderate-quality evidence that manual therapy with supervised exercises improves short-term walking capacity and results in small improvements in pain and symptom severity compared with self-directed or group exercise. The choice between rehabilitation and surgery for LSS is very uncertain owing to the very low quality of available evidence.

Keywords:   Exercise; Lumbosacral region; Meta-analysis; Rehabilitation; Spinal stenosis; Systematic review.



From the FULL TEXT Article:

Background

Approximately 1 in 5 adults 65 years or older experience degenerative lumbar spinal stenosis (LSS). [1, 2] LSS results from spinal canal narrowing that affects the spinal cord and nerve roots [3] and causes neurogenic claudication, pain and paresthesia in the gluteal region and legs, and limited walking capacity. [4, 5] Consequently, people with LSS engage in less physical activity than those with hip or knee osteoarthritis. [6] Only 4% of people with LSS meet guideline recommendations for healthrelated physical activity, [7] and LSS is associated with a higher prevalence of heart disease and hypertension. [8]

Treatments for LSS include surgical and nonsurgical options. LSS is the most common reason for older adults to undergo spine surgery. [9] Many nonsurgical treatments exist, including epidural steroid injections, [10–13] exercise, [5] and combined therapies such as manual therapy and exercise. [11, 14] Traditionally, outcomes such as pain and pain-related disability have been used to judge the effectiveness of therapies for LSS. However, the deleterious effect of LSS on physical capacity highlights the importance of assessing the effect of therapy on other patient-centered outcomes such as walking capacity and health-related physical activity behavior.

There is insufficient evidence to guide clinical decision making regarding the effectiveness of rehabilitation for LSS. [15] Therefore, this systematic review aimed to investigate the effectiveness of conservative nonpharmacologic therapies on pain, disability, physical capacity, and physical activity in patients with degenerative LSS.



Methods

This systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement guidelines. [16] The review protocol was developed prior to the conduct of the review and was prospectively registered with PROSPERO (CRD42020157848).

      Eligibility

We included full reports published in peer-reviewed scientific journals of randomized controlled trials of adults (?18y) with degenerative LSS treated with conservative nonpharmacologic interventions. Conservative interventions included physical treatments (eg, exercise or manual therapy) and psychological approaches (cognitive-behavioral therapy or behavior change interventions).We considered all comparison types, including sham therapy, active comparators, usual care, and no treatment. We excluded trials of mixed clinical populations and those evaluating the effects of postoperative therapy only. To be included, studies needed to report at least 1 of the following outcomes: quantitative measures of back pain intensity, leg pain intensity, symptom severity, pain-related disability, physical capacity (eg, muscle strength, walking distance), or self-reported or objectively measured physical activity behavior. Secondary outcomes were adverse events or other harms reportedly associated with the interventions.

      Search strategy

We conducted a comprehensive search of MEDLINE, EMBASE, CENTRAL,and PsycINFO from inception to November 4, 2019 without language restrictions. Key search terms included terms related to the relevant anatomy (eg, spine, spinal), pathology (eg, stenosis), and therapies (eg, rehabilitation, exercise, behavior change).Details of the search strategies applied to all databases are included in supplemental appendix S1 (available online at http://www.archivespmr.org/).Referencelistsofincludedarticlesweresearched.

      Screening

A 2–stage screening process was performed independently by pairs of review authors from a panel of 3 (S.J., N.W., J.H.). We first screened titles and abstracts to identify studies that potentially met the eligibility criteria. We then independently assessed the fulltext of articles to determine eligibility. Disagreements were resolved via discussion and arbitration with a third review author (S.D.) if needed.

      Data extraction and management

Two review authors (S.J., A.B.) independently extracted data into a customized form. Disagreements were resolved via discussion and arbitration with a third review author (J.H.) if needed. We extracted information on study populations (age, sex, clinical status), intervention and comparator descriptions, outcome measures, and the main findings of the included trials.

      Risk of bias

Two review authors (S.J., A.B.) independently assessed the risk of bias of included studies using the Cochrane Risk of Bias tool. [17] Disagreements were resolved via discussion and arbitration with a third review author (J.H.) if needed.We considered a study to be at low risk of bias ifwe rated 5 of the 6 bias domains as having low risk of bias. [18]

      Interpretation of treatment effects

Pooled outcomes comprised walking capacity measured with the self-paced walking test (meters walked), back and leg pain intensity measured with the 0– to 10–point numeric pain rating scale, pain related disability measured with the 0– to 100–point Oswestry disability index, and symptom severity and physical function measured with the Zurich Claudication Questionnaire. Reporting on the Zurich Claudication Questionnaire differed between trials; 2 trials1 [14, 19] reported the mean score across questions, whereas another trial [11] reported the sumof individual question scores.We converted the latter to reflect the average question score so that unstandardized mean differences could be compared across trials. The clinical importance of each treatment effect was interpreted as meeting estimates of the minimum clinically important difference for patients with LSS when available: 1.25 points for back pain intensity, 1.5 points for leg pain intensity, 5.0 points for pain-related disability, .36 points for symptomseverity, and .10 points for physical function. [20]

      Data synthesis

We categorized outcomes into 4 follow-up time points after randomization: immediate (≤2wk), short-term (>2wk to ≤3mo), intermediate (>3mo to <12mo), and long-term (?12mo). When multiple time points occurred in the same category, we used data closest to 1 week (immediate), 8 weeks (short-term), 6 months (intermediate), and 12 months (long-term). [18]

Pairs of review authors from a panel of 4 (S.J., A.B., N.W., J.H.) independently assessed the clinical diversity of the included trials and grouped these based on differences in trial populations, interventions, comparators, and outcomes, using clinical judgment. Results of clinically homogenous trials were pooled with random-effects models using Review Manager, version 5.3, software.a Treatment effect estimates were adjustedmean differences (MD) and 95% confidence intervals (CI) of change scores for pain, disability, and walking capacity. When change scores or adjusted estimates were not available, we used final scores and crude estimates. We assessed statistical heterogeneity by visually inspecting the forest plots for concordance of point estimates and confidence intervals, and with the I2 statistic. We interpreted I2 as follows: 0%–40% (heterogeneity might not be important), 30%–60% (may represent moderate heterogeneity), 50%–90% (may represent substantial heterogeneity), and 75%–100% (may represent considerable heterogeneity). [17]

Two review authors (S.D., J.H.) independently assessed the overall quality of the evidence for each pooled estimate using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) classification. [21] Disagreements were resolved by discussion. We downgraded ratings from “high quality” by 1 level for each limitation related to study design or execution (ie, risk of bias), inconsistency of results, and imprecision. Specifically, the quality of evidence was downgraded by 1 level when (1) greater than 50% of participants were from studies judged not to be at low risk of bias, (2) I2 values were greater than 50% or when noting discordance between point estimates or confidence intervals (inconsistency), or (3) when the overall sample size was less than 400 or when CIs indicated imprecise treatment effect estimation (imprecision). [22] We did not assess indirectness as this review focused on a specific population, comparisons, and outcomes. We did not consider publication bias owing to the small number of trials in each analysis. [17]



Results

      Search results

Table +
Figures

The search identified 1,718 records, of which 41 full-text studies were assessed after title and abstract screening. In total, 21 reports of 19 unique trials with data from 1,432 patients were included (Figure 1). Supplemental appendix S2 (available online at http://www.archives-pmr.org/) reports the reasons for exclusion of studies evaluated at the full-text assessment stage.

      Included studies

Table 1 summarizes the sample populations, interventions, comparators, outcomes, and main findings of the included trials. The mean age of participants ranged from 49.1 to 75.3 years. Trials reported 32 different outcomes. Pain intensity measured with a numeric rating scale (9 trials; 47%) or visual analog scale (8 trials; 42%), and pain-related disability measured with the Oswestry disability index (14 trials; 74%) or Roland-Morris disability index (2 trials; 11%) were the most commonly reported outcomes. Only 7 trials (37%) included adverse events as a formal trial outcome. Five trials (26%) measured walking capacity with the self-paced walking test.

There was large diversity in the types of interventions and comparisons. Multimodal interventions were tested in most trials (14 trials; 74%). Common rehabilitation components included exercise (14 trials; 74%), manual therapy or traction (8 trials; 42%), passive physical modalities (7 trials; 37%), as well as psychological (eg, cognitive behavioral therapy) and educational components (4 trials, 21%).

Treatment comparisons most often included active therapies such as rehabilitation interventions (9 trials, 47%), oral or injected medications (5 trials, 26%), and surgery (2 trials, 11%). Few trials included sham therapy (3 trials, 16%), minimal treatment (3 trials, 16%), or no treatment (2 trials, 11%) comparisons.

We categorized intervention contrasts as: supervised exercise and manual therapy versus self-directed or group exercise (3 trials), multimodal rehabilitation versus surgery (3 reports of 2 trials), multimodal rehabilitation versus epidural steroid injection (3 trials), passive modalities versus sham therapy (3 trials), rehabilitation versus minimal treatment (3 trials), multimodal treatment contrasts (3 trials), and other comparisons (4 reports of 3 trials). Data from 3 trials comparing supervised exercise and manual therapy versus self-directed or group exercise and data from 2 trials comparing rehabilitation versus surgery were pooled for metaanalysis.

      Risk of bias and quality of evidence

Risk of bias outcomes are reported in Figures 2 and 3. Six trials were found to have a low risk of bias. [11, 12, 14, 26, 35, 36] Performance bias was the most common source of bias (91% of trials), which is to be expected given the nature of the therapies evaluated in this review. Reporting bias (36% of trials) and detection bias (32% of trials) were also common. Tables 2 and 3 provide summaries of findings and quality of evidence (GRADE) ratings for the pooled treatment effect estimates. The overall quality of evidence ranged from very low to moderate.

      Effectiveness of interventions

Supervised exercise and manual therapy versus self-directed or group exercise   We identified 3 trials (2 with low risk of bias) reporting on the effects of supervised exercise and manual therapy versus selfdirected or group exercise interventions on walking capacity, back pain intensity, leg pain intensity, symptom severity, or self reported physical function (Figure 4). Pooled effects from 3 trials (n=316) [11, 14, 19] provided low quality evidence that exercise and manual therapy increase short-term walking capacity (MD, 293.3 m; 95% CI, 61.7–524.9 m; I2=79%), whereas pooled effects from 2 trials (n=214) [11, 14] showed no difference in intermediate-term walking capacity (low quality evidence).

Pooled effects from 2 trials (n=180) provided moderate quality evidence (downgraded for imprecision) that exercise and manual therapy result in short-term improvements in back pain (MD, –1.1; 95% CI, –1.8 to –.4; I2=15%) and leg pain (MD, –.9; 95% CI, –1.5 to –.2; I2=0%) intensity less than thresholds for clinical importance. [14, 19] Pooled effects from 3 trials (n=326) provided low quality evidence (downgraded for inconsistency and imprecision) that exercise and manual therapy improve short-term symptom severity (MD, –0.3; 95% CI, –0.4 to –0.2; I2=54%), with differences less than estimates of clinical importance. [14, 19] Pooled effects from 2 trials showed no intermediate-term differences (moderate quality evidence, downgraded for imprecision) in symptom severity. [11, 14] Pooled results provided low (downgraded for inconsistency and imprecision) to moderate (downgraded for imprecision) quality evidence of no difference in self-reported physical function in the short term (3 trials, n=326) [11, 14, 19] or intermediate term (2 trials, n=220). [11, 14]

Two trials reported adverse event outcomes; however, these data could not be pooled owing to reporting differences. One trial of 104 patients reported 15 adverse events among patients receiving supervised exercise and manual therapy, and 24 adverse events among patients receiving self-directed exercise (eg, worsened back or extremity pain). [14] One serious, pain-related adverse event (requiring hospital care) was reported in each treatment group. Another trial of 259 patients reported 226 minor adverse events (eg, transient muscle soreness): 80 by patients receiving supervised exercise and manual therapy, 79 among patients receiving medical care comprising oral medications, with or without epidural steroid injections and activity advice, and 67 among patients participating in group exercise classes. [11] No serious adverse events were reported.

Multimodal rehabilitation versus surgery   We identified 3 reports of 2 high-risk-of-bias trials reporting on the effects of multimodal rehabilitation versus surgery on intermediate-and long-term pain-related disability. Pooled effects from 2 trials [23, 24] (n=243–245) provide very low quality evidence (downgraded for risk of bias, inconsistency, and imprecision) of no difference in disability between rehabilitation and surgery in the intermediate or long-term (Figure 5). Two-year outcomes of the trial originally reported by Malmivaara et al [24] showed lower disability in surgically treated patients and no between-group differences in leg pain, back pain, walking ability, or walking capacity after 6 years. [25]

Both trials included adverse event reporting but reporting limitations prevented the pooling of data for this outcome. One trial reported 33 surgery-related and 9 rehabilitation-related events. [23] Another trial reported 8 perioperative and 4 postoperative events among patients receiving surgical treatment with no apparent tracking of adverse events among patients in the rehabilitation group. [24]

Multimodal rehabilitation versus epidural steroid injection   Clinically heterogeneous data from 2 trials comparing rehabilitation with epidural steroid injections, with or without other therapies, provided conflicting results. A low-risk-of-bias trial reported greater intermediate-term improvements in leg pain, back pain, disability, claudication symptoms, and walking capacity favoring manual therapy and acupuncture, with or without herbal medication, compared with epidural steroid injections, oral pain medica tion, heat, and transcutaneous electrical nerve stimulation. [12]

A trial with high risk of bias reported no short- or intermediate term differences in disability, physical capacity, or pain in patients receiving ultrasound, heat, transcutaneous electrical nerve stimulation, oral nonsteroidal anti-inflammatories, and a home exercise program compared with patients receiving oral nonsteroidal antiinflammatories and a home exercise program with or without epidural steroid injections. [13] Two adverse events were reported without identifying the treatment group or groups in which they occurred.

Passive modalities versus sham therapy   Clinically heterogeneous data from 3 trials provided mixed results. A low-risk-of-bias trial found no immediate-term difference in walking capacity between patients receiving a single session of either transcutaneous electrical nerve stimulation or sham therapy. No adverse events were reported.

A high-risk-of-bias trial found improved low back and leg pain, disability, functional mobility, and quality of life favoring pulsed electromagnetic field therapy compared with sham therapy at immediate- and short-term follow-up. [27] Another high-risk-of-bias trial with incomplete and unclear outcome reporting showed no apparent between-group differences in Swiss Spinal Stenosis questionnaire scores (symptom severity and function subscales), disability, walking performance, and pain intensity in the intermediate-term and reported no adverse events. [28]

Rehabilitation versus minimal treatment   Three clinically heterogeneous high-risk-of-bias trials compared the effects of rehabilitation with minimal treatment. One trial reported improved short-term leg pain, trunk muscle strength and endurance, lumbar range of motion, and walking capacity favoring supervised exercise versus usual care. [29] No adverse events were reported. A second trial found no short- or long-term betweengroup differences in back pain, leg pain, symptom severity, disability, or walking tolerance between patients participating in a self-directed exercise program with advice and education, compared with advice and education alone. [30] No adverse events were reported. The third trial reported improved short-term disability and leg pain favoring 3 weeks of supervised exercise and paracetamol (as indicated) versus paracetamol (as indicated) alone with no reported adverse events. [31]

Multimodal treatment comparisons   Three clinically heterogenous trials with high risk of bias compared various therapy combinations. Short-term improvements in pain and walking capacity favored aquatic exercise versus landbased exercise and physical modalities at 8 weeks that became nonsignificant by 3 months, with no adverse events reported. [32] A second trial found no short-term differences in disability or pain between patients receiving body weight-supported treadmill walking, home exercises, heat, and traction compared to cycling exercise, home exercises, heat, and traction. [33] A third trial reported no short- or long-term differences in disability, walking capacity, or leg pain between patients receiving manual therapy, body weightsupported treadmill walking, and lumbar flexion and other exercises versus lumbar flexion exercises, treadmill walking, and subtherapeutic ultrasound therapy. [34]

Other treatment comparisons   Four trials reported the effects of other therapies. One low-risk-of-bias trial comparing spinal manipulation to no treatment found no immediate between-group differences in back pain, leg pain, or lumbar range of motion, and reported no adverse events. [35] Another low-risk-of-bias trial compared the effect of an inflatable belt to a generic lumbar support, with no immediate difference in walking capacity and unclear adverse event reporting (adverse events measured but not reported). [26]

One high-risk-of-bias trial reported no between-group differences in disability but improved pain at intermediate- and long-term follow-up favoring epidural steroid injections and education compared with manual therapy, exercise, epidural steroid injections, and education. [10] This trial reported 3 adverse events, all among patients assigned to the epidural steroid injection and education group. Another high-risk-of-bias trial was conducted in 2 phases. [37] Phase 1 comprised a parallel-group trial reporting no immediate-term between-group differences in symptom severity, function, leg pain, back pain, or disability, with 2 weeks of walking stick use compared to no treatment. Phase 2 comprised a cross-over trial showing no immediate-term change in walking capacity (shuttle walking test) with or without a walking stick.



Discussion

The findings of this systematic review provide low to moderate quality evidence that some modes of rehabilitation affect short term outcomes for people with LSS. Meta-analyses with data from 2 or 3 trials showed that directed exercise and manual therapy is superior to self-directed or group exercise for improving shortterm walking capacity (low quality evidence), back and leg pain intensity (moderate quality evidence), and symptom severity (low quality evidence). These findings support the use of manual therapy with supervised exercises for patients with LSS. However, the treatment effect estimates from our meta-analyses for back pain (1.1 points on a 0– to 10–point scale), leg pain (.9 points on a 0– to 10–point scale), and symptom severity (.3 points on a 1– to 5–point scale) were just less than thresholds for clinically important differences among patients with LSS. [20] There is no estimate for minimally important change in walking capacity. Patients and clinicians will need to judge the meaningfulness of our pooled estimate of improved walking capacity (approximately 300 m). The quality rating of this evidence means that data from future trials are likely (pain) or very likely (walking capacity, symptom severity) to change these treatment effect estimates. [21]

Pooled results from 2 trials provided very low quality evidence that rehabilitation is no better than surgery at improving intermediate- or long-term disability. The quality rating of this evidence means that the treatment effect estimates are very uncertain. [21]

Clinical heterogeneity prevented the quantitative synthesis of additional intervention contrasts. Fifteen individual trials (4 low risk of bias), evaluating a variety of therapies, provided conflicting evidence of rehabilitation effectiveness. One trial with low risk of bias reported manual therapy and acupuncture to be superior to oral pain medication, epidural steroid injections, and passive modalities [12] for pain, disability, and walking capacity. Three additional low risk of bias trials showed no immediate benefit of transcutaneous electrical nerve stimulation compared to sham stimulation [36] or an inflatable compared to a lumbar support [26] for walking capacity, as well as a single spinal manipulation compared with no treatment for pain or function. [35]

The current review findings accord with and advance the results of related systematic reviews. Two previous reviews evaluated the effectiveness of nonoperative treatments for pain, function, or walking ability. [15, 38] These reviews found very low to low quality evidence that rehabilitation was not superior to various comparators for improving walking ability. Evidence from single trials suggested that rehabilitation was better than no treatment for leg pain and that treadmill walking and stationary cycling result in similar outcomes. [15] The current review included data from additional trials that allowed for the first pooled estimates of treatment effect.

Three previous systematic reviews compared the effects of surgery with conservative therapy with results consistent with the current review findings. [15, 39, 40] Two Cochrane reviews reported very low to low quality evidence of no intermediate- (6mo) or long-term (12mo) differences in pain-related disability between surgically treated patients and those receiving multimodal nonoperative care for LSS. [15, 39] A more recent systematic review reported the same result. [40] These reviews included data from a trial identified by our systematic search. [41] However, we excluded this trial at the full-text assessment stage as rehabilitation therapies were not provided to all patients not receiving surgery. We also included trial data not available when the Cochrane reviews were performed. [23] Despite these differences, the results of the pooled analyses were consistent across all 4 reviews.

As with other common musculoskeletal conditions, relatively few trials have compared the effects of surgery with conservative interventions for LSS. [42] Trials comparing surgical with nonsurgical interventions face a number of challenges that may explain the lack of comparative effectiveness evidence. These challenges include treatment nonadherence and crossover between treatment arms: patients with severe symptoms often cross over to the surgery group, whereas patients with a preference for surgery or conservative treatments tend to pursue their preferred treatment option, irrespective of treatment assignment. [41] Furthermore, the stark differences between surgical and conservative therapies may increase the difficulty of patient blinding. Therefore, understanding the comparative effectiveness of surgical versus conservative interventions for patients with LSS will be an important future research priority, and these trials should account for the unique challenges inherent to these treatment comparisons.

Although LSS has potential to adversely affect health-related physical activity behavior, we identified only 2 trials with a physical activity outcome. A low-risk-of-bias trial found group exercise, but not manual therapy and directed exercise, superior to medical care for increasing time in light to vigorous intensity physical activity in the short-term. [11] A high-risk-of-bias trial reported greater steps (pedometer measured) among people receiving a supervised versus self-directed exercise program. [19] Neither trial included behavior-change techniques [38] in the treatment protocols. Rehabilitation programs that include specific evidencedbased behavior change techniques might have the potential to improve physical activity behaviors and cardiovascular health in spinal stenosis patients, as has been shown in coronary heart disease patients. [43] Trials to date have focused on measures of pain, disability, and physical capacity. Although these outcomes are relevant to clinicians and patients, the systematic development of evidence-based behavior change interventions to improve physical activity behavior for patients with LSS will be an important focus for future research.

      Study limitations

The strengths of this systematic review include the a priori study protocol registration, sensitive search strategy of multiple databases with supplemental searching, the use of the Cochrane tool to assess risk of bias, and the GRADE system to appraise the overall quality of the evidence. The review results should be interpreted in the context of the limitations of the review and the included trials. The outcomes reported in our a priori protocol were pain intensity, disability, physical capacity, and physical activity. We made a post protocol decision to also include trials reporting outcomes measured with the Zurich Claudication Questionnaire (also known as the Swiss Spinal Stenosis Scale). We believed that this protocol deviation was warranted, as the constructs measured by this tool (symptom severity and function) are sufficiently similar to our predefined outcomes. We were unable to pool data for most intervention contrasts owing to important differences in study interventions, comparators, outcomes, or populations. In particular, few trials tested similar interventions and the processes of intervention development were unclear.

We rated more than 2 out of 3 (68%) of the included trials as high risk of bias, and this resulted in additional downgrading of evidence quality for the rehabilitation versus surgery contrasts. The sample sizes of included trials were generally small (median group size, 26; range, 7-86); consequently, the quality rating of all pooled estimates was downgraded for imprecision. Detailed descriptions of the treatments were often lacking, a common limitation of exercise-based intervention reporting. [44] Moreover, some intervention contrasts comprised treatments or approaches that do not reflect usual clinical practice (eg, exclusive use of passive modalities), thus limiting the utility of some trial results. Harms associated with treatment were often not reported or inconsistently reported. For example, some trials reported the number of patients who experienced an adverse event, [14] or the number of event occurrences,11 whereas others reported events within only 1 treatment arm [24] or not at all. [19]

These findings imply that larger, low-risk-of-bias trials with detailed reporting of interventions and adverse events are warranted. Specifically, future trials should focus on a limited number of interventions, therapeutic protocols that can be easily applied by clinicians, and standard outcomes to facilitate future meta-analyses. Trials with a surgical treatment arm should address the challenges that make such comparisons particularly challenging, including treatment nonadherence and crossover, as well as difficulty with blinding.



Conclusions

For people living with LSS, there is low-to-moderate quality evidence that supervised exercise with manual therapy improves short-term walking capacity and results in small improvements in pain and symptom severity compared with self-directed or group exercise. The choice between rehabilitation and surgery for LSS is very uncertain owing to the very low quality of available evidence. Larger, high quality trials with complete reporting of interventions and adverse events are urgently needed.


Corresponding author

Jeffrey J. Hebert, DC, PhD, University of New Brunswick, 90 Mackay Drive, Fredericton, New Brunswick, Canada E3B 5A3.



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