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Cost-effectiveness of combined manipulation, stabilizing exercises, and physician consultation compared to physician consultation alone for chronic low back pain: a prospective randomized trial with 2-year follow-up [with consumer summary]
Niemisto L, Rissanen P, Sarna S, Lahtinen-Suopanki T, Lindgren KA, Hurri H
Spine 2005 May 15;30(10):1109-1115
clinical trial
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

STUDY DESIGN: A prospective, randomized controlled trial. OBJECTIVE: To examine long-term effects and costs of combined manipulative treatment, stabilizing exercises, and physician consultation compared with physician consultation alone for chronic low back pain (cLBP). SUMMARY OF BACKGROUND DATA: An obvious gap exists in knowledge concerning long-term efficacy and cost-effectiveness of manipulative treatment methods. METHODS: Of 204 patients with cLBP whose Oswestry Disability Index (ODI) was at least 16%, 102 were randomized into a combined manipulative treatment, exercise, and physician consultation group (ie, a combination group), and 102 to a consultation alone group. All patients were clinically examined, informed about their back pain, and encouraged to stay active and exercise according to specific instructions based on clinical evaluation. Treatment included 4 sessions of manual therapy and stabilizing exercises aimed at correcting the lumbopelvic rhythm. Questionnaires inquired about pain (visual analog scale (VAS)), disability (ODI), health-related quality of life (15D Quality of Life Instrument), satisfaction with care, and costs. RESULTS: Significant improvement occurred in both groups on every self-rated outcome measurement. Within 2 years, the combination group showed only a slightly more significant reduction in VAS (p = 0.01, analysis of variance) but clearly higher patient satisfaction (p = 0.001, Pearson Chi2) as compared to the consultation group. Incremental analysis showed that for combined group compared to consultation group, a one-point change in VAS scale cost $512. CONCLUSIONS: Physician consultation alone was more cost-effective for both health care use and work absenteeism, and led to equal improvement in disability and health-related quality of life. It seems obvious that encouraging information and advice are major elements for the treatment of patients with cLBP.
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