Review written by: Dr. Brynne Stainsby (for RRS Education)
Study Title: Comprehensive non-surgical treatment versus self-directed care to improve walking ability in lumbar spinal stenosis: A randomized trial
Authors: Ammendolia C, Côté P, Southerst D, Schneider M et al.
Publication Information: Archives of Physical Medicine and Rehabilitation 2018; 99(12): 2408-2419.e2. doi: 10.1016/j.apmr.2018.05.014.
Lumbar spinal stenosis (LSS) is caused by age-related degenerative changes in older adults and is a leading cause of pain, disability and loss of independence.1,2 These degenerative changes lead to narrowing of the spinal canal, resulting in compression and diminished blood supply to spinal nerve roots.2 Clinically, this presentation is termed neurogenic claudication, presenting with symptoms of lower extremity pain, the sensation of heaviness, numbness, tingling or weakness with standing or walking.2 A defining characteristic of LSS is that symptoms are typically relieved by sitting and bending forward.2 Limited walking ability is the dominant functional impairment for patients with LSS and may lead to a progressive decline in health.3,4 It is also the most common reason patients seek care and is also associated with increased levels of depression, anxiety and hopelessness.4-6 It is also important to remember that the natural history of LSS suggests no significant improvement in walking ability over time.7
LSS is the most common reason for spinal surgery in older adults.8 However, most patients are managed non-surgically, despite the fact systematic reviews of non-surgical management suggest unproven benefit for improving walking outcomes.8-10
This randomized controlled trial was designed to compare the effectiveness of a structured, comprehensive, conservative treatment program with a focus on self-management and improved walking ability (including exercise, education and manual therapy, specifically lumbar spinal manipulation) to a self-directed program in improving walking ability in patients with neurogenic claudication due to LSS.
- From August 2014 to January 2016, 640 potential participants were screened for eligibility, yielding 106 who were eligible for this trial (two declined to participate).
- 104 participants were then randomized: 48 to the comprehensive group (originally 51, three dropped out) and 51 (originally 53, two dropped out). The two groups were similar at baseline. The follow-up rate at 12 months was 89%.
- At baseline, the combined average age of both groups was 70.6 years, 57% were female, 84% had leg symptoms for more than 12 months.
- The average maximum walking distance during the self-paced walk test (SPWT) was 328.7m.
At 8 weeks, and 3, 6 and 12-month follow-ups:
- Both groups demonstrated significant improvement in the SPWT.
- The comprehensive group (which included chiropractic care) demonstrated statistically significant and clinically important improvements in the SPWT compared to the self-directed group at each follow-up period.
- At each follow up, the proportion of participants who improved their walking distance by at least 30% (the minimal clinically important difference, or MCID) was significantly higher in the comprehensive group compared to the self-directed group (ex. 82% in comprehensive group versus 63% in self-directed group at 6-months – these percentages were approximately the same at 12 months, indicating a sustained effectiveness).
- Significant improvement in pain and function were observed in both groups at each follow-up.
- At 6 months, the comprehensive group showed statistically significant and clinically important improvement in the ODI walk score compared to the self-directed group. This was the only significant difference in secondary outcomes at this follow-up period.
- At 12 months, the comprehensive group showed statistically significant improvements and clinically important differences in the Zurich Claudication Questionnaire (ZCQ) scores compared to the self-directed group. There were also significant between-group adjusted mean differences favouring the comprehensive group in SF-36 (physical function and bodily pain scales).
- There were no between-group differences in reported compliance to exercise programs or co-interventions.
- At 6 months, 2 participants reported adverse events in the comprehensive group compared to 5 participants in the self-directed group.
- At 12 months, 0 participants reported adverse events in the comprehensive group compared to 2 participants in the self-directed group. The adverse events were related to a temporary increase in low back and/or leg symptoms.
- No participants reported cauda equina syndrome.
Clinical Application and Conclusions
This study suggests that a comprehensive, conservative training program including clinician instruction and supervision of exercises, manual therapy (including SMT) and a cognitive behavioral approach may be an effective and safe option for patients with neurogenic claudication due to LSS. Statistically significant and clinically important improvements in walking distance were found, with results favoring a structured, six-week comprehensive program (remember, the natural history of LSS is normally NO improvement in walking ability). This is therefore a highly meaningful outcome for patients with neurogenic claudication due to LSS.
Considering both groups received the same educational materials, exercises and self-management strategies, the role of supervised and individualized education and instruction, interactions with clinicians, manual therapy and/or cognitive behavioral interventions may be related to the superior improvements in the comprehensive group. Given these are evidence-based treatments for chronic low back pain11, this study further supports their use for patients with neurogenic claudication due to LSS, specifically.
This was an assessor-blinded, pragmatic randomized controlled trial conducted in an outpatient hospital clinic. Eligible participants were 50 years of age or older with symptoms of neurogenic claudication for at least three months, had imaging-confirmed spinal canal narrowing, were able to walk without assistance for at least 20 minutes but less than 30 minutes, were able to perform mild-moderate exercise and were not likely surgical candidates in the next 12 months. Patients with previous back surgery, cardiovascular disease or osteoarthritis of the lower extremities affecting walking ability, or psychiatric disorders were excluded. All participants provided consent after being referred to the study by medical doctors and chiropractors from hospitals and community clinics. Eligible and consenting participants were then randomized using a computerized random numbers table, sequentially numbered and sealed opaque envelopes.
The structured comprehensive conservative training program consisted of two 15-20 minute treatment sessions per week over a six-week period, followed by a single session four weeks later. These participants were scheduled as regular patients at an outpatient hospital clinic with treatments provided by licensed chiropractors. The following interventions were provided:
- Education: One-on-one instruction regarding self-management strategies using a cognitive behavioural approach (including problem-solving, pacing, relaxation, reassurance, positive reinforcement, goal-setting etc.)12, and training on the pelvic tilt to reduce lumbar lordosis and maximize spinal canal diameter when standing and walking.13
- Exercises: A standardized set of 18 exercises (focused on improving overall back and lower extremity fitness and facilitating lumbar flexion) was provided over the six weeks.14,15 These exercises were also part of a home exercise program. Stationary cycling was also strongly encouraged.
- Manual Therapy: A standardized combination of side posture, high-velocity, low-amplitude (HVLA) spinal manipulation (SMT); joint, soft tissue, and neural mobilization; lumbar flexion-distraction and manual muscle stretching.
- All participants in this group received an instructional video and workbook with education information and instructions. The workbook was also used to record the exercise and self-management activities. Lastly, the participants received a pedometer for self-monitoring and personal feedback.
The self-directed group received only the instructional video, workbook and pedometer and a single 15-30 minute training session with an independent chiropractor (not involved in the treatment of the comprehensive group).
The primary outcome of this study was the walking distance measured at 6-months using the self-paced walk test (SPWT).16 This test measures the distance walked without stopping for a maximum of 30 minutes.16 Specifically, the primary outcome was the proportion of participants that achieved at least 30% improvement from baseline. Secondary measures included: the Zurich Claudication Questionnaire (ZCQ) (17), the Oswestry Disability Index (ODI)18, the walking section of the ODI (18), Numeric Pain Scale (NPS)19, Fall Efficacy Scale (FES)20, the Short Physical Performance Battery (SPPB)21, Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36)22 and the Centre for Epidemiological Studies-Depression Scale (CES-D).23 The proportion of participants that achieved at least 50% improvement in the SPWT from baseline was also assessed.
At baseline, participants provided demographic and clinical information. Outcomes were assessed at baseline, 8 weeks and 3, 6 and 12 months after randomization. A standardized questionnaire was used at each follow-up period to assess adverse events, co-interventions and compliance. Full statistical analysis was provided in the published protocol for this trial.15
Study Strengths / Weaknesses
- This study featured a high-quality, randomized controlled design, including assessor blinding.
- Multiple and long-term follow-up assessments.
- Valid and objective primary outcome measures that are clinically meaningful to patients with LSS.
- A pragmatic design to increase the external validity (generalizability)of the trial.
- The description of the interventions was included in the paper for the comprehensive (chiropractic) treatment group.
- The primary limitation of this study relates to the inability to blind participants and clinicians (assessors were blinded though, as mentioned above).
- Given the SPWT allows for a maximum of 30 minutes of walking, it may have significantly underestimated the improvement in walking tolerance (that is, if a patient was eventually able to walk for longer than 30 minutes).
- The generalizability of the results is somewhat limited by the strict inclusion/exclusion criteria in this trial.
- A “natural history” (no treatment) group was not included and thus comparisons to natural history cannot be made (remember once again, the natural history for LSS is generally NOT good).
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- Fanuele JC, Birkmeyer NJ, Abdu WA et al. The impact of spinal problems on the health status of patients: have we underestimated the effect? Spine 2000; 25(12): 1509-14.
- Kobayashi S. Pathophysiology, diagnosis and treatment of intermittent claudication in patients with lumbar canal stenosis. World J Orthop 2014; 5(2): 134-45.
- Jansson KA, Nemeth G, Granath F et al . Health-related quality of life (EQ-5D) before and one year after surgery for lumbar spinal stenosis. J Bone Joint Surg (Br) 2009; 91(2): 210-6.
- Ammendolia C, Schneider M, Williams K et al. The physical and psychological impact of neurogenic claudication: the patients’ perspectives. JCCA 2017; 61(1): 18-31.
- Fritz JM, Delitto A, Welch WC, Erhard RE. Lumbar spinal stenosis: a review of current concepts in evaluation, management, and outcome measurements. Arch Phys Med Rehabil 1998; 79(6): 700-8.
- Sinikallio S, Aalto T, Airaksinen O et al. Depression and associated factors in patients with lumbar spinal stenosis. Disabil Rehabil 2006; 28(7): 415-22.
- Wessberg P, Frennered K. Central lumbar spinal stenosis: natural history of non-surgical patients. Eur Spine J 2017; 26(10): 2536-2542.
- Chen E, Tong KB, Laouri M. Surgical treatment patterns among Medicare beneficiaries newly diagnosed with lumbar spinal stenosis. Spine J 2010; 10(7): 588-94.
- Ammendolia C, Stuber KJ, Rok E et al. Nonoperative treatment for lumbar spinal stenosis with neurogenic claudication. Cochrane Database Syst Rev 2013; 8: CD010712. doi:10.1002/14651858.CD010712.
- Ammendolia C, Stuber K, Tomkins-Lane C et al. What interventions improve walking ability in neurogenic claudication with lumbar spinal stenosis? A systematic review. Eur Spine J 2014; 23(6): 1282-301.
- Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med 2017; 166(7): 514-530.
- Linton SJ, Andersson T. Can chronic disability be prevented? A randomized trial of a cognitive behavior intervention and two forms of information for patients with spinal pain. Spine 2000; 25(21): 2825-31; discussion 4.
- Chung SS, Lee CS, Kim SH et al. Effect of low back posture on the morphology of the spinal canal. Skeletal Radiol 2000; 29(4): 217-23.
- Ammendolia C, Chow N. Clinical outcomes for neurogenic claudication 1 using a multimodal program for lumbar spinal stenosis: a retrospective study. J Manipulative Physiol Ther 2015; 38(3): 188-94.
- Ammendolia C, Côté P, Rampersaud YR et al. The boot camp program for lumbar spinal stenosis: a protocol for a randomized controlled trial. Chiro Man Ther 2016; 24: 25.
- Tomkins CC, Battie MC, Rogers T et al. A criterion measure of walking capacity in lumbar spinal stenosis and its comparison with a treadmill protocol. Spine 2009; 34(22): 2444-2449.
- Stucki G, Daltroy L, Liang MH et al. Measurement properties of a self-administered outcome measure in lumbar spinal stenosis. Spine 1996; 21(7): 796-803.
- Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine 2000; 25(22): 2940-2952; discussion 2952.
- Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health 1990; 13(4): 227-36.
- Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol 1990; 45(6): P239-43.
- Guralnik JM, Ferrucci L, Pieper CF et al. Lower extremity function and subsequent disability: Consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci 2000; 55(4): M221-31.
- Haley SM, McHorney CA, Ware JE, Jr. Evaluation of the MOS SF-36 physical functioning scale (PF-10): I. Unidimensionality and reproducibility of the Rasch item scale. J Clin Epidemiol 1994; 47(6): 671-84.
- Radloff LS. The CES-D scale: A self-report depression scale for research in the general population. Appl Psychol Meas 1977; 1(3): 385-401.