Efficacy and safety of thread embedding acupuncture combined with conventional acupuncture for chronic low back pain: A study protocol for a randomized, controlled, assessor-blinded, multicenter clinical trial

We describe the protocol for a randomized controlled trial for investigation of the efficacy and safety of thread embedding acupuncture combined with conventional acupuncture for chronic low back pain. Methods: This randomized, controlled, assessor-blinded, 2-armed, parallel, multicenter clinical trial will include 38 outpatients with chronic low back pain recruited from 4 traditional Korean Medicine hospitals. The patients will be randomly allocated to a treatment group (conventional acupuncture + thread embedding acupuncture) and a control group (only conventional acupuncture) in a 1:1 ratio. The treatment group patients will receive thread embedding acupuncture treatment at 10 acupuncture points (multifidus muscle, 4 points; spinal erector muscles, four points; lumbar quadrate muscle, 2 points) once a week for 8 weeks (8 sessions). In addition, all patients will receive conventional acupuncture treatment at 14 acupuncture points (GV3, EX-B5, and bilateral BL23, BL24, BL25, BL26, BL40, and BL60) twice a week for 8 weeks (16 sessions). The primary outcome will be the change in the visual analog scale score from visit 1 to visit 16, analyzed by independent t tests, in both groups. The groups will also be compared with regard to the clinical relevance (minimal clinically important difference), quality of life (3-level version of Euroqol-5D), disability level (Roland and Morris Disability Questionnaire), global assessment (patient global impression of change), and safety. Co...
Source: Medicine - Category: Internal Medicine Tags: Research Article: Study Protocol Clinical Trial Source Type: research