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

BACKGROUND: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) affects many adult men worldwide. The currently available therapies offer little or no proven benefit for CP/CPPS. We designed this study to assess the efficacy of acupuncture therapy for the treatment of CP/CPPS. METHODS: This study is designed as a randomized, sham acupuncture-controlled trial. We will compare patients with CP/CPPS in an acupuncture group and a sham acupuncture group. Sixty-eight patients will be randomly allocated to receive acupuncture or sham acupuncture. The treatments will consist of 30-min sessions, three times weekly, for 8 weeks. The primary outcome measure is change in the weekly mean National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score from baseline through the 8-week treatment period. Secondary measures include the NIH-CPSI subscale scores, the total International Prostate Symptom Score (IPSS), patients’ response rate, and patient satisfaction after treatment. We will also assess changes in the NIH-CPSI total score from baseline at the 20(th) and 32(nd) week of follow-up. DISCUSSION: This is a randomized, sham-controlled trial of acupuncture treatment for CP/CPPS. The results of this trial will provide more evidence on whether acupuncture is efficacious for treating CP/CPPS. TRIAL REGISTRATION: Clinical Trials.gov NCT02588274