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
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Acupuncture
干预措施: Acupuncture (Other)
Sham acupuncture
干预措施: Sham acupuncture (Other)
结局指标
主要结局
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
时间窗: week 4
The National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) has a total score range from 0 to 43 and higher scores indicate more severe symptoms. The 9 items of this scale are stratified into 3 domains which are pain/discomfort (location/type, frequency and severity, 0-21 points), urinary symptoms (10 points) and quality of life (0-12 points). Mode 2, the scale is recorded the same day, but not at the hospital.
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
时间窗: week 4
The National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) has a total score range from 0 to 43 and higher scores indicate more severe symptoms. The 9 items of this scale are stratified into 3 domains which are pain/discomfort (location/type, frequency and severity, 0-21 points), urinary symptoms (10 points) and quality of life (0-12 points). Mode 1, the scale is recorded at the hospital within 10minutes after the twelfth (last) treatment of the 4-week treatment period, in the company of the outcome assessors.
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
时间窗: 1 to 3 days after the last acupuncture session
The National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) has a total score range from 0 to 43 and higher scores indicate more severe symptoms. The 9 items of this scale are stratified into 3 domains which are pain/discomfort (location/type, frequency and severity, 0-21 points), urinary symptoms (10 points) and quality of life (0-12 points). Mode 3, the scale is recorded at the hospital 1 to 3 days after the last acupuncture session.
次要结局
- Mode 2 of assessment of the changes from baseline of NIH-CPSI total score in the acupuncture group(week 4)
- Mode 1 of assessment of the changes from baseline of NIH-CPSI total score in the acupuncture group(week 4)
- The change from baseline of subscales scores of NIH-CPSI(week 4)
- The proportions of participants in each response category of the Global Response Assessment (GRA)(week 4)
- Mode 3 of assessment of the changes from baseline of NIH-CPSI total score in the acupuncture group(1 to 3 days after the last acupuncture session)
- The change from baseline of International Prostate Symptom Score (IPSS)(week 4)
研究者
Zhou Jing
Principal Investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences