Abstract
BackgroundLumbar spinal stenosis (LSS) causing neurogenic claudication is a leading cause of pain, disability and loss of independence in older adults. The prevalence of lumbar spinal stenosis is growing rapidly due to an aging population. The dominant limitation in LSS is walking ability. Postural, physical and psychosocial factors can impact symptoms and functional ability. LSS is the most common reason for spine surgery in older adults yet the vast majority of people with LSS receive non-surgical treatment. What constitutes effective non-surgical treatment is unknown. The purpose of this study is to evaluate the effectiveness of a multi-modal and self-management training program, known as the Boot Camp Program for LSS aimed at improving walking ability and other relevant patient-centred outcomes.MethodsWe will use a pragmatic two-arm randomized controlled single blinded (assessor) study design. Eligible and consenting participants will be randomized to receive from licensed chiropractors either a 6-week (twice weekly) self-management training program (manual therapy, education, home exercises) with an instructional workbook and video and a pedometer or a single instructional session with an instructional workbook and video and pedometer. The main outcome measure will be the self-paced walking test measured at 6 months. We will also assess outcomes at 8 weeks and 3 and 12 months.DiscussionSymptoms and functional limitations in LSS are variable and influenced by changes in spinal alignment. Physical and psychological factors result in chronic disability for patients with LSS. The Boot Camp Program is a 6-week self-management training program aimed at the multi-faceted aspects of LSS and trains individuals to use self-management strategies. The goal is to provide life-long self-management strategies that maximize walking and overall functional abilities and quality of life.Trial registrationClinicalTrials.gov ID: NCT02592642.
Highlights
Lumbar spinal stenosis (LSS) causing neurogenic claudication is a leading cause of pain, disability and loss of independence in older adults
Participants randomized to Group 1 will receive the standard approach provided at the Spinal Stenosis Clinic at Mount Sinai Hospital; tailoring will be required with respect to the intensity and type of exercise and manual therapy techniques used, not unlike usual practice
We selected a randomized controlled trial (RCT) design because it is the study design of choice when comparing the effectiveness of interventions
Summary
Design We will conduct a pragmatic two arm single blinded (assessor) RCT (Fig. 1). Source population Eligible participants are individuals who consult with specialists (orthopedists, neurosurgeons, rheumatologists, neurologists or physiatrists), family physicians or chiropractors for symptoms suggestive of neurogenic claudication at one of seven hospitals and several community clinics in Toronto, Canada and the surrounding area. Eligible potential participants will be given a pamphlet outlining information concerning the study and providing contact information for the trial coordinator. Interested and potentially eligible participants will be asked to contact the trial coordinator directly. The trial coordinator will provide details about the study and answer questions by phone. The coordinator will confirm eligibility including age, duration of symptoms and self-report walking ability. Interested participants who respond “NO” and meet the other inclusion/exclusion criteria will be given an appointment for an intake assessment at the study site (Mount Sinai Hospital in Toronto Canada). The assessment will confirm eligibility (Table 1) and will include a history, physical examination and a review of imaging results provided by the referring specialist. Eligible and willing participants will be asked to provide informed written consent.
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