Acupuncture for chronic prostatitis/chronic pelvic pain syndrome: study protocol for a randomized controlled trial
Abstract Background 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 tri...
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doaj-0bdb69a13a83428d971e4d192c40bb5d2020-11-24T21:28:24ZengBMCTrials1745-62152017-12-011811810.1186/s13063-017-2383-8Acupuncture for chronic prostatitis/chronic pelvic pain syndrome: study protocol for a randomized controlled trialZongshi Qin0Yan Liu1Kehua Zhou2Jiani Wu3Ran Pang4Ning Li5Chang Xu6Joey S. W. Kwong7Zhishun Liu8Department of Acupuncture and Neurology, Guang’anmen Hospital, China Academy of Chinese Medical SciencesData Centre of Traditional Chinese Medicine, China Academy of Chinese Medical SciencesCatholic Health System Internal Medicine Training Program, Sisters of Charity Hospital, University at BuffaloDepartment of Acupuncture and Neurology, Guang’anmen Hospital, China Academy of Chinese Medical SciencesDepartment of Urology, Guang’anmen Hospital, China Academy of Chinese Medical SciencesWest China Hospital, Sichuan UniversityChinese Evidence-Based Medicine Center and Chinese Cochrane Center, West China Hospital, Sichuan UniversityJC School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong KongDepartment of Acupuncture and Neurology, Guang’anmen Hospital, China Academy of Chinese Medical SciencesAbstract Background 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. Methods 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. Discussion This study will provide robust evidence on whether acupuncture is effective for relieving symptoms of CP/CPPS. Trials registration ClinicalTrials.gov, NCT03213938. Registered on 5 July 2017.http://link.springer.com/article/10.1186/s13063-017-2383-8AcupunctureChronic prostatitisChronic pelvic pain syndromeRandomized controlled trialProtocol |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Zongshi Qin Yan Liu Kehua Zhou Jiani Wu Ran Pang Ning Li Chang Xu Joey S. W. Kwong Zhishun Liu |
spellingShingle |
Zongshi Qin Yan Liu Kehua Zhou Jiani Wu Ran Pang Ning Li Chang Xu Joey S. W. Kwong Zhishun Liu Acupuncture for chronic prostatitis/chronic pelvic pain syndrome: study protocol for a randomized controlled trial Trials Acupuncture Chronic prostatitis Chronic pelvic pain syndrome Randomized controlled trial Protocol |
author_facet |
Zongshi Qin Yan Liu Kehua Zhou Jiani Wu Ran Pang Ning Li Chang Xu Joey S. W. Kwong Zhishun Liu |
author_sort |
Zongshi Qin |
title |
Acupuncture for chronic prostatitis/chronic pelvic pain syndrome: study protocol for a randomized controlled trial |
title_short |
Acupuncture for chronic prostatitis/chronic pelvic pain syndrome: study protocol for a randomized controlled trial |
title_full |
Acupuncture for chronic prostatitis/chronic pelvic pain syndrome: study protocol for a randomized controlled trial |
title_fullStr |
Acupuncture for chronic prostatitis/chronic pelvic pain syndrome: study protocol for a randomized controlled trial |
title_full_unstemmed |
Acupuncture for chronic prostatitis/chronic pelvic pain syndrome: study protocol for a randomized controlled trial |
title_sort |
acupuncture for chronic prostatitis/chronic pelvic pain syndrome: study protocol for a randomized controlled trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2017-12-01 |
description |
Abstract Background 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. Methods 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. Discussion This study will provide robust evidence on whether acupuncture is effective for relieving symptoms of CP/CPPS. Trials registration ClinicalTrials.gov, NCT03213938. Registered on 5 July 2017. |
topic |
Acupuncture Chronic prostatitis Chronic pelvic pain syndrome Randomized controlled trial Protocol |
url |
http://link.springer.com/article/10.1186/s13063-017-2383-8 |
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