Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
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|ClinicalTrials.gov Identifier: NCT02588274|
Recruitment Status : Completed
First Posted : October 27, 2015
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Prostatitis||Device: Acupuncture Device: placebo needle||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: Study Protocol for a Randomized, Placebo-controlled Trial|
|Actual Study Start Date :||November 2015|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||November 2017|
Zhongliao (BL 33), Shenshu (BL 23), Huiyang (BL 35), and Sanyinjiao (SP 6) acupuncture points (Table 1). After patients are in prone position with relax, the investigators will use 75% alcohol pads to sterile the skin around the acupuncture points, and then insert steel needles (Huatuo, Suzhou, China 0.3mm*40mm/0.3mm*75mm) into the acupuncture points. For bilateral Zhongliao (BL 33), the needle will be inserted into about 50-60mm with 45 degree, for Huiyang (BL 35), the needle will be inserted into 50-60mm. for Shenshu (BL 23) and Sanyinjiao (SP 6), the needles will be inserted vertically to a depth of 25-30 mm. The treatment sessions are 24 after baseline, 3 times a week, and the each time the patients will accept a 30 minutes treatment.
Acupuncture is one of the oldest standardized neuromodulatory therapies. The method of acupuncture treatment involves the insertion of needles in acupuncture points according to a system of channels and meridians. The needles are stimulated by manual manipulation, electrical stimulation or heat. The general theory of acupuncture is based on the premise that there are patterns of energy flow through the body that are essential for health. Disruptions of this flow are believed to be responsible for disease. Acupuncture may correct imbalances of flow at identifiable points close to the skin.
Other Name: needle
Placebo Comparator: placebo needle
The participants in placebo needle group will receive placebo needle at the same acupuncture points to treatment group. Investigators will use a sort of blunt needle that cannot penetrate skin and stimulate deep tissues while the thrusting and twisting manipulation will be used by acupuncturists to mock the treatment procedure and blind the patients. The duration and frequency of sessions are same to the treatment group.
Device: placebo needle
Placebo needle is a type of control without skin penetration based on the application of placebo needles with blunt needle tips.
- NIH-CPSI total score and change from baseline [ Time Frame: baseline, week 1-8 ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588274
|Guang'anmen Hospital, China Academy of Chinese Medical Science|
|Beijing, Beijing, China, 100053|
|Principal Investigator:||Zhishun Liu, PhD||Guang'anmen Hospital|