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
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.
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