Efficacy of acupuncture for chronic prostatitis/chronic pelvic pain syndromes on quality of life: study protocol for a randomized, sham acupuncture-controlled trial

BackgroundChronic prostatitis/chronic pelvic pain syndromes (CP/CPPS) is a common heterogeneous disease that seriously impacts patients quality of life (QoL). Acupuncture therapy has been widely used in China for various urinary diseases and symptoms, including chronic prostatitis. The results of several randomized controlled studies from different countries support that acupuncture can relieve the symptoms of CP/CPPS. Still, most randomized controlled trial (RCT) trials focus on symptom relief in patients, and the evidence on improving the QoL is insufficient. This study aims to assess the near-term and long-term efficacy of acupuncture in improving QoL in patients with CP/CPPS. Methods/DesignThis is a double-arm, parallel, participant-blinded RCT. 70 male CP/CPPS subjects aged 18-50 will be randomly allocated to either the acupuncture group or the sham acupuncture group. Participants will receive acupuncture or sham acupuncture treatment thrice a week over eight weeks for 24 sessions. The primary outcome will be the change in the total score of QoL compared with the baseline after eight weeks of treatment and 24 weeks of follow-up. The expectancy of acupuncture, blinding, and safety will also be assessed. A two-sided test will perform all statistical analyses, and a p-value of less than 0.05 will be considered statically significant. DiscussionThis study aims to provide quantitative clinical evidence of acupuncture effectiveness and safety in improving the QoL in patients with CP/CPPS. Clinical Trial RegistrationThis trial is registered at chictr.org.cn (Identifier: ChiCTR2100051115)