NCT02588274

Trial name or title	Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndromes.
Methods	Randomised controlled trial, parallel group assignment. Double blind (participants and outcome assessors).
Participants	Age 18‐50 years. Inclusion criteria: history of pain perceived in region of prostate and absence of other lower urinary tract pathology for ≥ 3 out of the past 6 months. In addition, associated lower urinary tract symptoms, sexual function and psychological factors should be addressed; age 18‐50 years; NIH‐CPSI total score ≥ 15 (scale 0‐43, and 0 means no symptom). Exclusion criteria: other urological disease (e.g. acute prostatitis, bacterial prostatitis, benign prostatic hyperplasia, prostate cancer, urinary tuberculosis, urinary tract infection); serious or acute diseases with heart, liver, kidney and blood system; participants who had received acupuncture or medication (including alpha‐blockers or pain killers) treatment in the week prior to the baseline assessment; participants without telephone number who cannot be connected during the follow‐up.
Interventions	'Experimental: Acupuncture 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.' 'Placebo Comparator: placebo needle The participants in placebo needle group will receive placebo needle at the same acupuncture points to treatment group.'
Outcomes	Primary outcome: NIH‐CPSI total score and change from baseline (baseline, and weeks 1 and 8). Secondary outcomes: NIH‐CPSI subscales score: baseline, and week 4, 8, 20 and 32; NIH‐CPSI total score in follow‐up: baseline, and weeks 4, 8, 20 and 32; IPSS total score and change from baseline: baseline, and weeks 4, 8, 20 and 32. Other outcomes (not relevant to this review): global response assessment improvement; degree of satisfaction.
Starting date	November 2015.
Contact information	Zhishun Liu: liuzhishun@aliyun.com.
Notes	Estimated study end: May 2017.