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.
METHODS
Prospective, randomized, controlled trial.


OBJECTIVE
To investigate the effectiveness of home-based exercise on pain, dysfunction, and quality of life (QOL) in Japanese individuals with chronic low back pain (CLBP).


BACKGROUND
Exercise 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.


METHODS
A 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.


RESULTS
In 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.


CONCLUSIONS
The home-based exercise prescribed and monitored by board-certified orthopedic surgeons was more effective than NSAIDs for Japanese patients with CLBP.
Shirado
Osamu
O
Department of Orthopaedic Surgery, Saitama Medical University, Saitama, Japan. oshirado@saitama-med.ac.jp
Doi
Tokuhide
T
Akai
Masami
M
Hoshino
Yuichi
Y
Fujino
Keiji
K
Hayashi
Kunihiko
K
Marui
Eiji
E
Iwaya
Tsutomu
T
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D002908:Chronic Disease / Q000628:therapy; D005081:Exercise Therapy; D005260:Female; D006801:Humans; D007564:Japan; D017116:Low Back Pain / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011446:Prospective Studies; D011788:Quality of Life; D012648:Self Care / Q000379:methods*; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal