Clinical trial NCT03641807: Different Modes of Assessment on Acupuncture Effect on Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Prostatitis
Chronic Pelvic Pain Syndrome
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* meet the diagnostic criteria according to the NIH CP/CPPS consensus: discomfort or pain in the pelvic region for at least 3 months in the previous 6 months
* 18-50 years
* NIH-CPSI total score ≥15

Exclusion Criteria:

* Urologic disease
* Residual urine volume ≥100 milliliter (mL)
* Qmax ≤15mL/s
* Use 5-alpha reductase inhibitor, alpha-blockers, antibiotics or any other prostatitis-specific medication during previous 1 month
* Diseases that influence urologic symptoms are multiple sclerosis, multiple system atrophy, stroke, Alzheimer disease, Parkinson's disease, spinal cord injury, cauda equina injury, and sexually transmitted disease
* Any acute disease or severe disease requiring treatment

Primary outcomes:
measure: The change from baseline in total score of National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) measured by the assessment of mode 1
timeFrame: week 4
measure: The change from baseline in total score of National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) measured by the assessment of mode 2
timeFrame: week 4
measure: The change from baseline in total score of National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) measured by the assessment of mode 3
timeFrame: 1 to 3 days after the last acupuncture session
Secondary outcomes:
measure: Mode 1 of assessment of the changes from baseline of NIH-CPSI total score in the acupuncture group
timeFrame: week 4
measure: Mode 2 of assessment of the changes from baseline of NIH-CPSI total score in the acupuncture group
timeFrame: week 4
measure: Mode 3 of assessment of the changes from baseline of NIH-CPSI total score in the acupuncture group
timeFrame: 1 to 3 days after the last acupuncture session
measure: The change from baseline of subscales scores of NIH-CPSI
timeFrame: week 4
measure: The change from baseline of International Prostate Symptom Score (IPSS)
timeFrame: week 4
measure: The proportions of participants in each response category of the Global Response Assessment (GRA)
timeFrame: week 4
Other outcomes:
measure: Expectancy of acupuncture
timeFrame: Baseline
measure: Blinding assessment
timeFrame: week 4
measure: Incidence of adverse events (AEs) related with acupuncture
timeFrame: week 1 to week 4
Locations:
city: Changsha
country: China
facility: The First Hospital of Hunan University of Chinese Medicine
state: Hunan
city: Hengyang
country: China
facility: Hengyang Hospital Affiliated to Hunan University of Chinese Medicine
state: Hunan
city: Yantai
country: China
facility: Yantai Hospital of Traditional Chinese Medicine
state: Shandong
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References: