Clinical trial NCT02588274: Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Official title: Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: Study Protocol for a Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Prostatitis
Keywords: Chronic prostatitis
chronic pelvic pain syndrome
acupuncture
placebo needle
randomized controlled trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 68
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: Inclusion Criteria:

1. History of pain perceived in the region of the prostate and absence of other lower urinary tract pathology for a minimum of 3 out of the past 6 months. In addition, associated lower urinary tract symptoms, sexual function, psychological factors should be addressed.
2. Age 18 to 50 years
3. NIH Chronic Prostatitis Symptom Index (NIH-CPSI) total score≥ 15 (scale 0-43, and 0 means no symptom).

Exclusion Criteria:

1. Other urologic disease (for example, acute prostatitis, bacterial prostatitis, benign prostatic hyperplasia, prostate cancer, urinary tuberculosis, urinary tract infection)
2. Serious or acute diseases with heart, liver, kidney and blood system.
3. Patients who had received acupuncture or medication (including alpha-blockers or pain killers) treatment in the week prior to the baseline assessment
4. Patients without telephone number who cannot be connected during the follow-up

Primary outcomes:
measure: NIH-CPSI total score and change from baseline
timeFrame: baseline, week 1-8
Secondary outcomes:
measure: NIH-CPSI subscales score
timeFrame: Baseline, week 4,8,20,32
measure: NIH-CPSI total score in follow-up
timeFrame: week 20,32
measure: IPSS total score and change from baseline
timeFrame: baseline, week 4,8,20,32
measure: Global response assessment improvement
timeFrame: week 4,8,20,32
measure: expectations degree
timeFrame: baseline
measure: Degree of satisfaction
timeFrame: week 8,20,32
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Science
state: Beijing
Study officials:
affiliation: Guang'anmen Hospital
name: Zhishun Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qin Z, Zang Z, Wu J, Zhou J, Liu Z. Efficacy of acupuncture for chronic prostatitis/chronic pelvic pain syndromes: study protocol for a randomized, sham acupuncture-controlled trial. BMC Complement Altern Med. 2016 Nov 7;16(1):440. doi: 10.1186/s12906-016-1428-y.