Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

NCT02588274 | Completed DMC

• 1 other identifier: 2015S102
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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 .

Conditions

Chronic Prostatitis

Keywords

Chronic prostatitis; chronic pelvic pain syndrome; acupuncture; placebo needle; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• NIH-CPSI total score and change from baseline

  baseline, week 1-8

Secondary Outcomes (6)

• NIH-CPSI subscales score

  Baseline, week 4,8,20,32

• NIH-CPSI total score in follow-up

  week 20,32

• IPSS total score and change from baseline

  baseline, week 4,8,20,32

• Global response assessment improvement

  week 4,8,20,32

• expectations degree

  baseline

Study Arms (2)

Acupuncture

EXPERIMENTAL

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.

Device: Acupuncture

placebo needle

PLACEBO COMPARATOR

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

Interventions

Acupuncture DEVICE

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.

Also known as: needle

Acupuncture

placebo needle DEVICE

Placebo needle is a type of control without skin penetration based on the application of placebo needles with blunt needle tips.

placebo needle

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Age 18 to 50 years
• NIH Chronic Prostatitis Symptom Index (NIH-CPSI) total score≥ 15 (scale 0-43, and 0 means no symptom).

You may not qualify if:

• Other urologic disease (for example, 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.
• Patients who had received acupuncture or medication (including alpha-blockers or pain killers) treatment in the week prior to the baseline assessment
• Patients without telephone number who cannot be connected during the follow-up

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Science

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (1)

• 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.

  PMID: 27821109 DERIVED

MeSH Terms

Interventions

Acupuncture Therapy; Needles

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Equipment and Supplies

Study Officials

• Zhishun Liu, PhD

  Guang'anmen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Department of Acupuncture

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 27, 2015
• Study Start: November 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: November 1, 2017
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

CN (1)