Study on Efficacy and Safety of Shi’s Manual Therapy Treatment for Lumbar Disc Herniation with Radiculopathy: Study Protocol for A Multicenter Randomized Controlled Trial
Abstract Background Lumbar disc herniation (LDH) is a common chronic musculoskeletal disorder that seriously affects quality of life. Percutaneous endoscopic lumbar diskectomy (PELD) technique was developed to address spine nerve root compression by direct visualization of pathological findings while minimizing tissue destruction upon exposure. It is an effective and safe treatment for LDH. However, recurrent LDH is a major concern after lumbar discectomy for primary LDH. A considerable number of clinical studies reported that patients will benefit from manual therapy practice for LDH with radiculopathy patients. Shi's manual therapy (SMT) is established based on the Traditional Chinese medicine (TCM) theory, which has been shown to have a superior effect in alleviating muscle tension and loosen joints to improve lumbar and leg pain, radiculopathy, stiffness, activity discomfort, and related disorders. But there is a lack of high-quality clinical evidences to support the conclusion. The purpose of this study will be to evaluate the efficacy and safety of the combination of Shi’ manual therapy (SMT) for reducing the recurrent rate of LDH with radiculopathy. Methods/design: A multicenter randomized controlled trial (RCT) with a 1years’ follow-up period will be performed. A total of 510 participants with LDH with radiculopathy will be recruited in four clinical centers. Sample size estimation was calculated and statistical analysis will be performed calculated and supervised by biostatisticians from the independent third-party research institution. Two hundred and fifty-five subjects will be randomly allocated to each group. The subject in the control group will undergo the PELD. Participants in the intervention group will be treated with SMT, and the straight leg raising angle will be evaluated. If the patients’ straight leg raising the angle of the affected side is close to the healthy side, and the treatment is finished, if not, the PELD procedure will proceed. The primary outcome will be the recurrence rate of LDH with radiculopathy and the ODI score. The secondary outcome measures will be the VAS score for the pain of lumbar and lower limbs, the straight leg raising angle, the stability of the operated lumbar segment, and SF-36 scores. Assessments will occur at baseline, post-operation, and at 1week, 4 weeks, 13 weeks, 26 weeks and 1year post-operation. In addition, adverse events related to clinical symptoms and signs and results of laboratory tests will be documented during the clinical trials. Discussion This study will provide reliable evidence of the effectiveness and safety of the combination of SMT and PELD for LDH with radiculopathy. If the results are favorable, it is expected that the patients with LDH with radiculopathy will benefit from this study, many patients may have a good alternative treatment for LDH with radiculopathy. Trial registration: ChiCTR, ChiCTR2000036515. Registered on 13 November 2020.
