The role of acupotomy in treatment of patients with lumbar spinal stenosis: A protocol for a randomized study

BACKGROUND: Currently, there is some clinical evidence supporting the use of acupuncture in alleviating pain and dysfunction in patients with lumbar spinal stenosis (LSS). However, the question of whether acupuncture could be efficacious for ageing patients remains unanswered. We designed a randomized controlled study to evaluate the safety and feasibility of acupuncture for participants with symptomatic LSS. METHODS: This study is a randomized, single-blind, noninferiority trial. This clinical trial was approved by the Linyi Cancer Hospital. We received informed consent from all patients before surgery. In preparing this report, we adhered to the Consolidated Standards of Reporting Trials guidelines. We randomized consented study participants on a 1:1 ratio to one of two study groups (acupuncture and control groups) using a computer-generated list of random numbers in varying block sizes. Three outcome measures were selected to evaluate the effectiveness and safety of the treatment: visual analogue score and Oswestry disability index, and complicatins. A P < .05 was regarded as statistically significant. RESULTS: The hypothesis was that the acupuncture group would achieve acceptable clinical outcomes as compared to the control group in LSS. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5744).