Effectiveness and safety of acupotomy for treating back and/or leg pain in patients with lumbar disc herniation: A study protocol for a multicenter, randomized, controlled, clinical trial

This study is planned as a multicenter, parallel design, randomized, controlled, clinical study. One hundred forty-six patients diagnosed with LDH will be randomly assigned to either the acupotomy group or the manual acupuncture group at a 1:1 ratio. Participants in both groups will receive a total of 4 interventions over 2 weeks. An effectiveness assessment based on the outcomes on the visual analog scale (VAS), Roland Morris Disability Questionnaire (RMDQ), Modified-Modified Schober Test (MMST), EuroQol Five Dimensions (EQ-5D), and Patient Global Impression of Change (PGIC) will be conducted at baseline and at 2, 4, and 6 weeks postrandomization. The primary outcome will be the mean change in the VAS for back and/or leg pain 4 weeks postrandomization. Adverse events will be recorded at every visit. Discussion: The results of this study will provide evidence for the effectiveness and safety of acupotomy treatment for patients with LDH. Trial registration: Clinical Research Information Service of South Korea (CRIS- KCT0002824), April 24, 2018.
Source: Medicine - Category: Internal Medicine Tags: Research Article: Study Protocol Clinical Trial Source Type: research