Efficacy of electroacupuncture therapy in patients with functional anorectal pain: study protocol for a multicenter randomized controlled trial.

BACKGROUND

Some Chinese scholars have initially explored the efficacy of electroacupuncture at Baliao acupoint in patients with functional anorectal pain (FAP). However, their studies are performed in a single center, or the sample size is small. Therefore, we aim to further explore the efficacy of electroacupuncture at Baliao acupoint on the treatment of FAP.

METHODS

In this multicenter randomized controlled trial, 136 eligible FAP patients will be randomly allocated into an electroacupuncture group or sham electroacupuncture group at a 1:1 ratio. This trial will last for 34 weeks, with 2 weeks of baseline, 4 weeks and 8 weeks of treatment, and 1, 3, and 6 months of follow-up. Outcome assessors and statisticians will be blind. The primary outcome will be clinical treatment efficacy, and secondary outcomes will be pain days per month, quality of life, psychological state assessment, anorectal manometry, pelvic floor electromyography, and patient satisfaction.

DISCUSSION

Results of this trial will be contributed to further clarify the value of electroacupuncture at Baliao acupoint as a treatment for FAP in the clinic.

TRIAL REGISTRATION

This trial has been registered in Chinese Clinical Trial Registry  https://www.chictr.org.cn/  (ChiCTR2300069757) on March 24, 2023.