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

Background Chronic 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/Design This 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. Discussion This study aims to provide quantitative clinical evidence of acupuncture effectiveness and safety in improving the QoL in patients with CP/CPPS. Clinical Trial Registration This trial is registered at [chictr.org.cn][1] (Identifier: ChiCTR2100051115) ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ChiCTR2100051115 ### Clinical Protocols ### Funding Statement This work was supported by Fengtai District Health System Research Project (No. 2019-90). Yu-Long Ding received this award. Webside: http://www.bjft.gov.cn/ftq/zfgg/201911/c8dba26474854711b3cfb4f0cfcef8c1.shtml ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Ethics Committee of the Beijing Fengtai District Integrated Chinese and Western medicine hospital reviewed and approved these studies involving human participants. Patients/participants provided their written informed consent to participate in the study. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Deidentified research data will be made publicly available when the study is completed and published. * CP/CPPS : chronic prostatitis/chronic pelvic pain syndromes QoL : quality of life RCT : randomized controlled trial NIH : National Institutes of Health AF : atrial fibrillation NSCLC : non-small cell lung cancer Acu Group : acupuncture treatment group Sham Group : sham needle control group BUCM : Beijing University of Chinese Medicine NIH-CPSI : National Institutes of Health Chronic Prostatitis Symptom Index CRF : case report form WHO : World Health Organization BL : Bladder Meridian SP : Spleen Meridian SF-36 : the MOS item short-form health survey IPSS : international prostate symptom score LUTS : lower urinary tract symptoms MCID : minimal clinically important difference VAS : visual analog scale AEs : adverse events DSMB : the data and safety monitor board ANOVA : analysis of variance [1]: http://chictr.org.cn