Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Condition: Chronic Prostatitis
MeSH terms: Prostatitis; Pelvic Pain; Chronic Disease
Study type: Interventional

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.
    

Intervention name(s): Acupuncture; placebo needle
Intervention type(s): Device; Device
Intervention description(s): 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.; Placebo needle is a type of control without skin penetration based on the application of placebo needles with blunt needle tips.
Other intervention name(s): needle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic prostatitis; chronic pelvic pain syndrome; acupuncture; placebo needle; randomized controlled trial