Analyzing the Brain Alterations of Acupuncture on Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome Evaluated by fMRI: Study Protocol for a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The change in the NIH-CPSI total score at the end of week 12 and week 36
研究概览
简要总结
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is one of the most common diseases in urology, but its pathogenesis remains unclear and the effective therapy lacks. As a kind of chronic pain which the patients suffered for more than 3 months, CP/CPPS could be alleviated by acupuncture. Functional magnetic resonance imaging (fMRI) and higher magnetic field strengths could enable scientists to investigate the brain accurately and non-invasively during every stage of chronic pain.To avoid placebo effect, sham acupuncture would be also enrolled.Herein, by the utilization of fMRI in resting-state, we investigated the influence on patients' brain alterations after the patients accepted the treatment of acupuncture.
详细描述
A two (participant and assessor) blind, two-arm parallel, randomized controlled trial will be conducted. Sixty patients with CP/CPPS will be recruited from Huashan Hospital, Shanghai, and thirty healthy volunteers will be recruited as the healthy control group by advertisement. Patients will be randomly assigned into one of two intervention groups: acupuncture group and sham acupuncture group. The ratio of healthy control (n = 30), acupuncture group (n = 30) and sham acupuncture group (n = 30) will be 1:1:1. Sanyinjiao (SP6), Zhibian (BL54), Shenshu (BL23), and Huiyang (BL35) are chosen as acupoints for both acupuncture group and sham acupuncture group (Park sham device). The course of treatment is 2 times a week in three months (totally 24 times). The group of healthy control will get only once fMRI scan while the group of patients will get fMRI scan week 0 (before treatment), week 12 (after treatment) and week 36 (following up). Every time the participants receive the fMRI scan, they will be asked to finish the clinical scales. The primary outcome will be the change in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score from baseline to week 12 and week 36. Secondary outcomes will include the changes of Hospital Anxiety and Depression Scale, International Prostate Symptom Score, International Index of Erectile Function, Self-Esteem Scale, Social Support Rating Scale and Numeric Rating Scale and brain functional activated or inactivated regions.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Owing to differentiating the acupuncture effect from placebo effect, the participants and outcomes assessors are needed to be masked.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •(1)The clinical diagnosis of CP/CPPS is exclusionary diagnosis.The main steps of diagnosing CP/CPPS are follwing: T
- •he chief complaint is long-term recurrent pain or discomfort of lumbosacral and perianal distension in the lower abdomen of the external perineum genital area and the superior pubic area (more than 3 months).
- •Bacterial prostatitis will be eliminated by routine culture of prostatic fluid and urine culture before and after prostatic massage.
- •Urinary tract infection will be ruled out by routine urinalysis and sediment examination.
- •(2)Total score of NIH-CPSI ≥ 15.
排除标准
- •The participants would be excluded if they got any acute or chronic infectious disease, other chronic pain diseases, internal organic diseases, history of malignant tumors, and chronic diseases that might contribute to peripheral nerve injury like diabetes mellitus and hypertension.
- •Prostate changes will be observed by prostate ultrasound and other urogenital and pelvic space-occupying lesions will be excluded.
- •Contraindications of fMRI scan like claustrophobia and denture implantation status are also considered.
结局指标
主要结局
The change in the NIH-CPSI total score at the end of week 12 and week 36
时间窗: week 0, week 12 and week 36
The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) , compared with the baseline in week 0.It is because a decline of at least 6 points in NIH-CPSI is acknowledged as the minimal clinically important difference. The NIH-CPSI is a self-assessment form with nine items, which the main components encompass pain with 4 items focused on location, severity and frequency, urinary function embracing one irritative item and one obstructive item, and quality of life impact with 3 items about the effect of symptoms on daily activities. The NIH-CPSI provides a systematized and unanimously accepted outcome measuring tool, and it is widely used in clinical trials, along with in the evidence-based evaluation of treatment effects.
次要结局
- The alterations in brain of patients with CP/CPPS measured by fMRI when finishing the whole treatment(week 12)
- The alterations in brain of patients with CP/CPPS measured by fMRI in the following-up (24weeks after treatment)(week 36)
- the change from baseline in the Social Support Rating Scale (SSRS)(week 0, week 12, week 36)
- the change from baseline in NIH-CPSI(week 0, week 12, week 36)
- the change from baseline in the International Prostate Symptom Score (IPSS)(week 0, week 12, week 36)
- the change from baseline in the Visual Analogue Scale (VAS)(week 0, week 12, week 36)
- the change from baseline in NIH-CPSI subscales(week 0, week 12, week 36)
- the change from baseline in the Self-Esteem Scale (SES).(week 0, week 12, week 36)
- the change from baseline in the Quality of Life（QoL)(week 0, week 12, week 36)