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Different Modes of Assessment on Acupuncture Effect on Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Chronic Pelvic Pain Syndrome Clinical Trial

Official title:
The Comparison of Three Different Modes of Assessment on Acupuncture Effect on Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Study Protocol for a Randomized Controlled Trial

Clinical Trial Summary

Background: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common disorder. Some studies have indicated that acupuncture may ameliorate the symptoms of CP/CPPS. However, results are varied and range widely, perhaps due to different modes of assessment including timepoints, places of assessment, and especially subjective scales. We propose to determine the efficacy of acupuncture relative to sham acupuncture for patients with CP/CPPS, and compare different modes of assessment regarding the therapeutic effects of acupuncture.

Methods: Sixty patients with CP/CPPS will be randomly assigned to receive either acupuncture or sham-acupuncture (30 patients, each). Treatment will be conducted 3 times/week, for 4 weeks. The primary outcomes will each be the change from baseline of the total NIH (National Institutes of Health) CPSI (Chronic Prostatitis Symptom Index) score associated with 3 modes of assessment: Mode 1, the scale recorded at the hospital within 10minutes after the last session of 4 weeks of acupuncture treatment, in the company of the outcome assessors; Mode 2, the scale recorded the same day, but not at the hospital; and Mode 3, the scale recorded at the hospital 1 to 3 days after the last acupuncture session. The 3 key secondary outcomes include will be the 3 modes assessment of the changes from baseline of the NIH-CPSI total scores in the acupuncture group at week 4 after treatment. Analysis was by intention-to-treat, and multiplicity was controlled for with a step-down closed-testing procedure.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03641807
Study type Interventional
Source Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Contact Jing Zhou, Master
Phone 86-010-15650729586
Email zjinbj@sina.com
Status Recruiting
Phase N/A
Start date November 1, 2018
Completion date October 30, 2021
View Details
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