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Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02588274
Recruitment Status : Completed
First Posted : October 27, 2015
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Qin Zongshi, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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 .

Condition or disease Intervention/treatment Phase
Chronic Prostatitis Device: Acupuncture Device: placebo needle Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: Acupuncture
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.




Primary Outcome Measures :
  1. NIH-CPSI total score and change from baseline [ Time Frame: baseline, week 1-8 ]

Secondary Outcome Measures :
  1. NIH-CPSI subscales score [ Time Frame: Baseline, week 4,8,20,32 ]
  2. NIH-CPSI total score in follow-up [ Time Frame: week 20,32 ]
  3. IPSS total score and change from baseline [ Time Frame: baseline, week 4,8,20,32 ]
  4. Global response assessment improvement [ Time Frame: week 4,8,20,32 ]
  5. 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?

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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China, Beijing
Guang'anmen Hospital, China Academy of Chinese Medical Science
Beijing, Beijing, China, 100053
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Investigators
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Principal Investigator: Zhishun Liu, PhD Guang'anmen Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Qin Zongshi, Doctor of Department of Acupuncture, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT02588274    
Other Study ID Numbers: 2015S102
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Keywords provided by Qin Zongshi, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Chronic prostatitis
chronic pelvic pain syndrome
acupuncture
placebo needle
randomized controlled trial
Additional relevant MeSH terms:
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Prostatitis
Pelvic Pain
Chronic Disease
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Disease Attributes