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01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Trials 1/2017

Acupuncture for chronic prostatitis/chronic pelvic pain syndrome: study protocol for a randomized controlled trial

Trials > Ausgabe 1/2017
Zongshi Qin, Yan Liu, Kehua Zhou, Jiani Wu, Ran Pang, Ning Li, Chang Xu, Joey S. W. Kwong, Zhishun Liu
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Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-2383-8) contains supplementary material, which is available to authorized users.



Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common condition affecting men of all ages. Acupuncture may be an effective treatment option for CP/CPPS, but evidence is limited. We propose to evaluate the effectiveness of acupuncture in a rigorously conducted trial.


Ten hospitals will recruit 440 participants with CP/CPPS in China from October 2017 to December 2019. Participants will be randomly allocated to acupuncture or sham acupuncture with a 1:1 ratio using computerized simple random sampling. The whole study consists of 2-week baseline, 8-week treatment, and 24-week follow up. Twenty 30-mintute sessions of acupuncture or sham acupuncture treatment will be provided between week 1 and 8. The two co-primary outcomes are the proportion of responders at week 8 and week 32. Secondary outcomes include proportion of responders in the two groups at different time points; change in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score; change in the NIH-CPSI subscales; change in the International Prostate Symptom Score; change in the Hospital Anxiety and Depression Scale; expectation assessments; proportions of participants in each response category of the Global Response Assessment; change in the International Index of Erectile Function 5; change in the five-level EuroQol five-dimensional questionnaire and a visual analogue scale; and changes in peak and average urinary flow rate.


This study will provide robust evidence on whether acupuncture is effective for relieving symptoms of CP/CPPS.

Trials registration, NCT03213938. Registered on 5 July 2017.
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