Abstract
BackgroundLow back pain is among the most common and costly chronic health care conditions. Recent research has highlighted the common occurrence of non-specific low back pain in adolescents, with prevalence estimates similar to adults. While multiple clinical trials have examined the effectiveness of commonly used therapies for the management of low back pain in adults, few trials have addressed the condition in adolescents. The purpose of this paper is to describe the methodology of a randomized clinical trial examining the effectiveness of exercise with and without spinal manipulative therapy for chronic or recurrent low back pain in adolescents.Methods/designThis study is a randomized controlled trial comparing twelve weeks of exercise therapy combined with spinal manipulation to exercise therapy alone. Beginning in March 2010, a total of 184 participants, ages 12 to 18, with chronic or recurrent low back pain are enrolled across two sites. The primary outcome is self-reported low back pain intensity. Other outcomes include disability, quality of life, improvement, satisfaction, activity level, low back strength, endurance, and motion. Qualitative interviews are conducted to evaluate participants’ perceptions of treatment.DiscussionThis is the first randomized clinical trial assessing the effectiveness of combining spinal manipulative therapy with exercise for adolescents with low back pain. The results of this study will provide important evidence on the role of these conservative treatments for the management of low back pain in adolescents.Trial registration(ClinicalTrials.gov NCT01096628).
Highlights
Low back pain is among the most common and costly chronic health care conditions
This is the first randomized clinical trial assessing the effectiveness of combining spinal manipulative therapy with exercise for adolescents with low back pain
Low back pain prevalence and burden in adolescents Low back pain (LBP) in adolescents has become increasingly recognized as a public health concern, with an estimated one year prevalence of 34% [1]
Summary
LBP is a significant health problem for adults, and for children and adolescents. While SMT and exercise have been shown to be effective in adult populations, high quality research is needed to investigate their effectiveness in adolescent LBP patients. Explanatory design aspects of the trial aimed at ensuring high validity and low risk of bias include: the use of multiple baseline assessments to ensure participant compliance; eligibility criteria to exclude individuals unlikely to demonstrate treatment effects (e.g., pain intensity ≥ 3/10); restricted utilization of cointerventions during the intervention phase; structured protocols for the application of the intervention (number of visits, exercise, or SMT techniques used); application of the intervention at university-associated research clinics by clinicians with investigator supervision; and monitoring of participant and provider compliance including strategies to maximize adherence to study protocols. All authors provided critical evaluation and revision of the manuscript and have given final approval of the manuscript accepting responsibility for all aspects
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