Research Review By Dr. Joshua Plener©


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Date Posted:

May 2022

Study Title:

Non-operative treatment for lumbar spinal stenosis with neurogenic claudication: an updated systematic review


Ammendolia C, Hofkirchner C, Plener J, Bussières A, Schneider MJ et al.

Author's Affiliations:

Faculty of Medicine, University of Toronto, Canada; Rheumatology, Sinai Health System, Toronto, Canada; Graduate Education and Research, Canadian Memorial Chiropractic College, Toronto, Canada; School of Physical and Occupational Therapy, Faculty of Medicine and Health Sciences, McGill University; Physical Therapy, University of Pittsburgh, USA

Publication Information:

BMJ Open 2022; 12(1): e057724. doi:10.1136/bmjopen-2021-057724

Background Information:

Lumbar spinal stenosis (LSS) leading to neurogenic claudication is a significant health challenge among older adults, leading to a reduction in their walking ability, significantly impacting their functional abilities and overall quality of life. Neurogenic claudication is a clinical diagnosis and the main syndrome of LSS, consisting of bilateral or unilateral buttock pain and/or lower extremity discomfort, pain, weakness or heaviness precipitated by walking and prolonged standing and relieved by stooping forward and sitting (1, 2). LSS results from degenerative changes to the discs, facet joints and ligaments which lead to narrowing of the central and/or lateral spinal canals causing compression and/or ischemia of the spinal nerves (1, 3).

Patients with LSS typically receive non-operative care as a first-line treatment (1, 4). In 2013, this group of authors published a Cochrane review evaluating the effectiveness of non-operative management for lumbar spinal stenosis causing neurogenic claudication – this paper was reviewed on RRS at that time (5, 6). The review in 2013 identified 21 RCTs with the quality of evidence rated as low or very low. The purpose of this study is to update the 2013 review and determine the current state of the literature on non-operative treatment for neurogenic claudication.

Pertinent Results:

15 200 studies were identified from the data base searches, with 23 new RCTs meeting the inclusion criteria, adding to the initial 21 RCTs identified from the first review. 3792 participants were included in the studies and randomized to one of 60 comparison groups. 17 studies evaluated rehabilitation therapy or multimodal care, 11 assessed epidural injections, 7 evaluated oral medications, 6 assessed calcitonin, 2 evaluated acupuncture, and 1 assessed spinal manipulation.

Risk of bias:
9 studies were deemed to be low risk of bias, with the remaining studies being rated as high risk of bias with fatal flaws.

53 of the 60 comparisons were examined in a single trial, with most including small sample sizes. Only data from 2 trials were able to be combined in a meta-analysis, with the remaining studies being discussed qualitatively.

There were no new studies assessing calcitonin, with 6 studies from the previous review demonstrating very low-quality evidence that Calcitonin is no better than placebo or paracetamol (Tylenol).

Oral medication:
Four new studies were identified assessing five oral medications:
  • There is low quality evidence that pregabalin improves pain, distance walked, function and global health status. However, there was increased reporting of adverse events in the pregabalin group compared to placebo.
  • There is very low-quality evidence that gabapentin plus conservative care provides no significant improvement in back/leg pain, disability scores or global health.
  • There is very low-quality evidence that oxymorphone hydrochloride or propoxyphene and acetaminophen are no better than placebo.
  • There is very low-quality evidence that oral corticoids do not improve outcomes compared to placebo in the short term.
The original review identified three studies, concluding that there is low quality evidence that prostaglandins improve walking distance and leg pain compared with NSAIDs in the short term, very low-quality evidence that gabapentin improves walking distance and pain compared with placebo in the intermediate and long terms, and methylcobalamin plus conservative treatment improves walking distance in the intermediate and long term compared with conservative treatment alone.

Rehabilitation therapy and multimodal treatment:
Eight new studies evaluating 13 rehabilitation treatment approaches were identified:
  • There is moderate quality evidence that manual therapy and exercise provides superior and clinically important short-term improvements in symptoms and function compared with medical care or community-based group exercise, and community-based group exercise improves physical activity in the short term compared with medical care.
  • There is moderate quality evidence that comprehensive care demonstrates superior and clinically important improvements for walking distance at all time points compared to self-directed home exercise.
  • There is low quality evidence from one trial that manual therapy, acupuncture and physician care with or without an herbal remedy improves low back pain in the intermediate term.
  • There is low quality evidence that supervised physical therapy improves symptoms, function and walking distance in the short term compared with home exercise.
  • There is very low-quality evidence that heat, TENS, and home exercises are no better than isokinetic exercise for all outcomes and time points.
  • There is very low-quality evidence that aquatic exercise is more effective than physical therapy for pain and walking distance in the immediate term.
  • There is very low-quality evidence that a pre-surgical exercise program improves post-surgical outcomes in the immediate term follow up.
  • There is low quality evidence that a structured physical therapy program provides similar outcomes to decompression surgery in the long-term.
The original review identified nine rehabilitation therapy/multimodal trials, of which five compared rehabilitation to surgical interventions. Two of the original surgical trials have published eight-year follow-up results, which demonstrated no difference in the outcomes assessed. In the original review, the meta-analysis completed on two of the trials demonstrated that laminectomy improves outcomes only at the two-year follow up compared with conservative care.

Epidural injection:
6 new studies were identified that assessed epidural injections:
  • There is moderate quality evidence from one study that glucocorticoid plus lidocaine is better than lidocaine alone in improving pain and function in the short term. These findings were statistically significant but not clinically significant.
  • There is very low-quality evidence that a lidocaine injection is no better than saline injection in the short term.
  • There is very low-quality evidence that steroid injections at the level of maximal stenosis improves pain and function in the short term.
  • There is very low-quality evidence that steroid injections are no better than steroid injection combined with physical therapy in improving pain and function.
  • There is low quality evidence that tumour necrosis factor alpha inhibitor injections improve pain and function compared with steroids or lidocaine injections.
  • There is very low-quality evidence that minimally invasive lumbar decompression surgery is no better than epidural steroid injections in the short term.
The original review identified four trials evaluating seven epidural injection approaches, all demonstrating very low-quality evidence for all outcomes.

2 new studies were identified assessing acupuncture:
  • There is low quality evidence that acupuncture improves back and leg pain compared with sham acupuncture.
  • There is very low-quality evidence that acupuncture plus usual care is no better than usual care alone in the short term for all outcomes.
Spinal manipulation:
1 study was identified which found very low-quality evidence that spinal manipulation alone is no better than a wait list control in the immediate term for all outcomes.

Clinical Application & Conclusions:

60 treatment comparisons were evaluated in this systematic review, and of them, five comparisons from three trials provided moderate quality evidence. The remaining comparisons provided low or very low-quality evidence.

Overall, there is now moderate quality evidence that a multimodal, structured, six-week program of care consisting of manual therapy and exercise with or without education is an effective treatment approach for neurogenic claudication and should represent first-line care for this condition. As well, there is moderate quality evidence that epidural steroid injections do not provide clinically important improvements in the short term or long term compared with epidural lidocaine injections. Future studies are needed, as even though the evidence from these three trials are (collectively) moderate quality, there is a lack of consistency as the findings come from single studies. However, a recent clinical practice guideline concurs with the findings of this systematic review.

This review can be used to inform future clinical practice guidelines and assist clinicians and patients to make reasonable clinical decisions regarding treatment options. In clinical practice, patients often decide between a non-surgical and surgical treatment approach for their condition. Based on this review, high-quality evidence for the effectiveness of surgery is lacking but ongoing clinical trials comparing disc decompression surgery with sham surgery should help provide further insight into the effectiveness of surgery for lumbar spinal stenosis.

Study Methods:

The following databases were searched from January 2011 to July 2020: CENTRAL, MEDLINE, EMBASE, CINAHL, and Index to Chiropractic Literature.

The population of interest was individuals with imaging confirmed lumbar spinal stenosis and neurogenic claudication. Lumbar spinal stenosis was identified as central or foraminal, with or without spondylolisthesis. Neurogenic claudication is a clinical diagnosis defined as buttock or leg pain and/or aching, numbness, tingling, weakness or fatigue with or without back pain, precipitated by standing or walking.

There were no age restrictions for the studies, and interventions of interest included all non-operative treatments, with comparisons being any treatment, including surgery. Outcomes of interest included at least one of the following: walking ability, pain intensity, physical function, quality of life or global improvement.

Inclusion criteria:
  • RCTs published in peer-reviewed English journals
  • At least one arm of the trial provided data on effectiveness of non-operative treatment
  • At least 80% of subjects had neurogenic claudication with imaging confirmed lumbar spinal stenosis
Exclusion criteria:
  • Studies did not meet the inclusion criteria outlined above
  • Studies evaluating subjects with radiculopathy caused by disc herniations without neurogenic claudication
Article screening and data extraction:
Two pairs of independent reviewers screened all titles and abstracts, with a third reviewer consulted if consensus was not reached. Two reviewers independently assessed methodological risk of bias using the Cochrane Risk of Bias Tool 1. This tool includes 12 criteria and low risk of bias was defined as fulfilling 6 or more of the 12, including clearly described and appropriate randomization and allocation concealment, with no severe flaws. A severe flaw was defined a priori as a serious methodological deficiency that was not captured by the ROB-1 tool, including very high dropout or cross-over rates, and a sample size of less than 30 subjects per treatment arm.

Outcomes were evaluated at the following time points: immediate term which is up to 1-week post-intervention, short term which is between 1 week and 3 months, intermediate term which is 3 months and 1 year, and long term which is 1 year or longer. Meta-analyses were completed if trials were sufficiently homogenous. Results were assessed based on statistical and clinically significant findings.

Rehabilitation therapy consisted of treatment using any combination of education, exercise, instruction, manual therapy, heat and cold applications, electrotherapy, other physical therapy modalities, orthosis, and other assistive devices. Multimodal treatment included a combination of rehabilitation therapy treatments, oral and other medications, and spinal injections, but not surgery.

Quality of evidence:
GRADE was used to assess the overall quality of evidence through assessing five domains: risk of bias, consistency of findings, directness of comparisons, precision of estimates, and other considerations such as selective reporting.

Study Strengths / Weaknesses:

  • This review assesses a wide range of non-operative interventions and used consistent inclusion and exclusion criteria for neurogenic claudication.
  • This review only included lumbar spinal stenosis diagnosed via imaging, to ensure that all included participants indeed had narrowing of the central canal or lateral foraminae.
  • This review utilized rigorous Cochrane methods as well as the GRADE method to synthesize the quality of the evidence.
  • We should celebrate the mainly chiropractic author group on this paper and also the fact that it was published in a major, open access medical journal (BMJ Open)!
  • This review only included English articles.
  • Studies with small sample sizes were included – such studies are more prone to a high risk of bias. Over half the included studies had a sample size of less than 30 subjects per treatment arm.
  • Risk of bias assessments had a cut-off point of six or more to differentiate between low and high risk of bias. This value was arbitrary and therefore different definitions and cut off points could have impacted the findings and conclusions of this review.
  • Minimal clinically important differences (MCIDs) were used to assess clinical significance. The validity of the MCIDs used is unknown as there are no agreed upon MCIDs in the lumbar spinal stenosis literature.

Additional References:

  1. Katz JN, Harris MB, et al. Lumbar spinal stenosis. N Engl J Med 2008; 358: 818–25.
  2. Comer CM, Redmond AC, Bird HA, et al. Assessment and management of neurogenic claudication associated with lumbar spinal stenosis in a UK primary care musculoskeletal service: a survey of current practice among physiotherapists. BMC Musculoskelet Disord 2009; 10: 121.
  3. Kobayashi S, Pathophysiology KS. Pathophysiology, diagnosis and treatment of intermittent claudication in patients with lumbar canal stenosis. World J Orthop 2014; 5: 134–45.
  4. Fritz JM, Delitto A, Welch WC, et al. Lumbar spinal stenosis: a review of current concepts in evaluation, management, and outcome measurements. Arch Phys Med Rehabil 1998; 79: 700–8.
  5. Ammendolia C, Stuber K, de Bruin LK, et al. Nonoperative treatment of lumbar spinal stenosis with neurogenic claudication: a systematic review. Spine 2012; 37: E609–16.
  6. Ammendolia C, Stuber KJ, Rok E, et al. Nonoperative treatment for lumbar spinal stenosis with neurogenic claudication. Cochrane Database Syst Rev 2013; 8: CD010712.

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