Clinical Trial: Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndromes
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndromes: Study Protocol for a Randomized, Placebo-controlled Trial
Brief Summary: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) affects many adult men worldwide. So far, available therapies offer little or no proven benefit to CP/CPPS. The investigators design and implement this study is to assess efficacy of acupuncture therapy performed in the CP/CPPS .
Detailed Summary: This study is a multi-center, placebo-controlled, randomized trial comparing acupuncture and placebo needle among patients with CP/CPPS, which will be conducted in Guang'anmen Hospital of China Academy of Chinese Medical Sciences and Yantai Chinese Medicine Hospital from November 2015 to May 2017. 68 patients will be recruited in total through the advertisements spreading by newspaper, television and internet. After participants have completed a baseline evaluation and meet the selection criteria, one professional statistician uninvolved with treatment and data collection will assigns the participants by using a computer generated, blocked random allocation sequence randomly and acupuncturist will be blinded to the process of randomized assignment.Treatment group will use acupuncture and control group will use placebo needle, for treatment, Zhongliao (BL 33), Shenshu (BL 23), Guiyang (BL 35), Sanyinjiao (SP 6) acupuncture points will be used, the treatment sessions are 24 weeks after baseline, 3 times a week and each time the patients will accept a 30 minutes treatment, to control group, participants will receive placebo needle treatment at the same acupuncture points and the duration and frequency of sessions are same to the real acupuncture group. The primary outcome measure of this study is the decreasing in (National Institutes of Health Chronic Prostatitis Symptom Index) NIH-CPSI total score from baseline to week 8, and secondary outcomes include NIH-CPSI sub scales at week, (International Prostate Symptom Score) IPSS total score, Global response assessment, expectation degree and satisfaction degree. The first three secondary outcomes will be measured at 4,8,20 and 32 weeks, expectation degree will be measured at baseline, and the satisfaction degree will be measure at 8, 20, 32 weeks.
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Current Primary Outcome: NIH-CPSI total score and change from baseline [ Time Frame: baseline, week 1-8 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- NIH-CPSI subscales score [ Time Frame: Baseline, week 4,8,20,32 ]
- NIH-CPSI total score in follow-up [ Time Frame: week 20,32 ]
- IPSS total score and change from baseline [ Time Frame: baseline, week 4,8,20,32 ]
- Global response assessment improvement [ Time Frame: week 4,8,20,32 ]
- expectations degree [ Time Frame: baseline ]The expectations that acupuncture might help participants CP/CPPS at baseline. This scale includes two brief questions to investigate whether patients believe acupuncture treatment and if acupuncture may help CP/CPPS. The investigators designed this scale and the investigators want to explore the impact of variable that are potentially associated with placebo effects, namely will participants' expectations be treatment effect modifier?
- Degree of satisfaction [ Time Frame: week 8,20,32 ]The investigators designed this scale, which include 5 grades answer from 0 to 4, means "not at all" "a little" "Quite satisfied" "satisfaction" "very satisfaction"and the investigators want to use this to test blinding of participants.
Original Secondary Outcome: Same as current
Information By: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Dates:
Date Received: October 20, 2015
Date Started: March 2016
Date Completion: June 2017
Last Updated: December 4, 2016
Last Verified: August 2016
