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Integrative TCM conservative therapy for low back pain due to lumbar disc herniation: a randomized controlled clinical trial |
Yuan WA, Huang SR, Guo K, Sun WQ, Xi XB, Zhang MC, Kong LJ, Lu H, Zhan HS, Cheng YW |
Evidence-Based Complementary and Alternative Medicine 2013;(309831):Epub |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; 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* |
Low back pain due to lumbar disc herniation (LDH) is very common in clinic. This randomized controlled trial was designed to investigate the effects of integrative TCM conservative therapy for low back pain due to LDH. A total of 408 patients with low back pain due to LDH were randomly assigned to an experimental group with integrative TCM therapy and a control group with normal conservative treatment by the ratio of 3:1. The primary outcome was the pain by the visual analogue scale (VAS). The secondary outcome was the low back functional activities by Chinese Short Form Oswestry Disability Index (C-SFODI). Immediately after treatment, patients in the experimental group experienced significant improvements in VAS and C-SFODI compared with the control group (between-group difference in mean change from baseline -16.62 points, p < 0.001 in VAS; -15.55 points, p < 0.001 in C-SFODI). The difference remained at one-month followup, but it is only significant in C-SFODI at six-month followup (-7.68 points, p < 0.001). No serious adverse events were observed. These findings suggest that integrative TCM therapy may be a beneficial complementary and alternative therapy for patients with low back pain due to LDH.
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