• Spine · Aug 2010

    Randomized Controlled Trial Multicenter Study

    Multicenter randomized controlled trial to evaluate the effect of home-based exercise on patients with chronic low back pain: the Japan low back pain exercise therapy study.

    • Osamu Shirado, Tokuhide Doi, Masami Akai, Yuichi Hoshino, Keiji Fujino, Kunihiko Hayashi, Eiji Marui, Tsutomu Iwaya, Japan Low back-pain Exercise Therapy Study, Investigators Japanese Orthopaedic Association, Japanese Society for Musculoskeletal Rehabilitation, and Japanese Clinical Orthopaedic Association.
    • Department of Orthopaedic Surgery, Saitama Medical University, Saitama, Japan. oshirado@saitama-med.ac.jp
    • Spine. 2010 Aug 1;35(17):E811-9.

    Study DesignProspective, randomized, controlled trial.ObjectiveTo investigate the effectiveness of home-based exercise on pain, dysfunction, and quality of life (QOL) in Japanese individuals with chronic low back pain (CLBP).Summary Of Background DataExercise therapy is a widely used treatment for CLBP in many countries. The studies on its effectiveness have been performed only in Western industrialized countries. The existence of cross-cultural differences and heterogeneity of patients in each country may influence the outcome of interventions for CLBP. Data that would enable researchers to compare the effectiveness of interventions between widely different societies is lacking.MethodsA total of 201 patients with nonspecific CLBP were randomly assigned to either the control or exercise therapy group: 89 men and 112 women with a mean age of 42.2 years. The control group was treated with nonsteroidal anti-inflammatory drugs (NSAIDs), and the exercise group performed trunk muscle strengthening and stretching exercises. The primary outcome measures were pain intensity (visual analogue scale) and dysfunction level (Japan Low back pain Evaluation Questionnaire [JLEQ] and Roland-Morris Disability Questionnaire [RDQ]) over 12 months. The secondary outcome measure was FFD (Finger-floor distance). Statistical analysis was performed using Wilcoxon signed-ranks and Mann-Whitney U tests, and estimation of the median with 95% CI was calculated.ResultsIn both groups, significant improvement was found at all points of follow-up assessment. However, JLEQ and RDQ were significantly more improved in the exercise group compared to the control group (P = 0.021 in JLEQ, P = 0.023 in RDQ). The 95% CI for the difference of medians of the change ratio between exercise and NSAID groups, [Exercise] - [NSAID], was -0.25 to -0.02 in JLEQ, -0.33 to 0.00 in RDQ, and -0.20 to 0.06 in visual analogue scale.ConclusionThe home-based exercise prescribed and monitored by board-certified orthopedic surgeons was more effective than NSAIDs for Japanese patients with CLBP.

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