Investigation and Treatment of Central Nervous System Dysfunction in Chronic Pelvic Pain.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Pain Assessment
研究概览
简要总结
The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective in reducing pain in subjects with chronic pelvic pain. Our hypothesis is that tDCS will decrease pain significantly when compared to sham stimulation.
详细描述
The study encompasses two experiments: The first one involves patients with chronic pain, receiving 10 sessions of stimulation, active or sham (parallel design).
The second experiment involves involves healthy subjects, receiving active or sham tDCS over the primary motor cortex (crossover design).
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Providing informed consent to participate in the study
- •18 to 64 years old
- •Having symptoms of pelvic pain for more than 6 months with an average of 3 on a 0-10 VAS scale (for pelvic pain subjects only)
- •No history of or current genitourinary tuberculosis as self reported
- •No history of urethral cancer as self reported
- •No history or current bladder malignancy, high grade dysplasia or carcinoma in situ as self reported
- •No occurrence of ovarian, vaginal or cervical cancer in the previous 3 years as self reported
- •No current vaginal infection as self reported
- •No active herpes in previous 3 months as self reported
- •No antimicrobials for urinary tract infections in previous 3 months as self reported
- •Never treated with cyclophosphamide as self reported
- •No radiation cystitis as self reported
- •No neurogenic bladder dysfunction (due to a spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida or diabetic cystopathy) as self reported
- •Absence of bladder, ureteral or urethral calculi for previous 3 months as self reported
- •No urethritis for previous 3 months as self reported
- •No urethral dilatation, cystometrogram, bladder cystoscopy with full anesthesia or bladder biopsy in previous 3 months as self reported
- •Must not be pregnant
- •Eligible to MRI according to MRI screening checklist
- •No contraindications to tDCS:
- •No history of alcohol or drug abuse within the past 6 months as self reported
- •No use of carbamazepine as self reported
- •Does not have severe depression (with a score of >30 in the Beck Depression Inventory)
- •No history of neurological disorders as self reported
- •No history of unexplained fainting spells as self reported,
- •No history of head injury resulting in more than a momentary loss of consciousness as self reported
- •Have had no neurosurgery as self reported
- •No history of psychological disorders as self reported
- •Must have the ability to feel pain as self reported
排除标准
- 未提供
结局指标
主要结局
Pain Assessment
时间窗: baseline and at 2 weeks
We use the Visual analogue scale (VAS) to measure pain. The VAS is ranged from 0 to 10, with 0 reffering to no pain and 10 reffering the the worst possible pain. We used the difference between post treatment minus baseline to compare the two treatments (active versus sham tDCS).
Pressure Pain Threshold
时间窗: baseline and at 2 weeks
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. The change in pressure pain threshold (post minus pre intervention) is use for the analysis.
次要结局
- Quality of Life Scale (QOLS)(2 weeks)
- Clinical Global Impression - CGI(2 weeks)
- Mini Mental Scale - MMS(2 weeks)
- Diffuse Noxious Inhibitory Controls - DNIC.(baseline and at 2 weeks)
- Beck Depression Inventory - BDI.(2 weeks)
- Pain Pressure Threshold Test - PPT(baseline and at 2 weeks)
- Visual Analogue Scale - Anxiety.This Scale Measures Patients' Level of Anxiety on a Scale (0-no Anxiety to 10-worst Anxiety Ever). It Was Performed at the End of the Treatment and Compared Between the 2 Groups (Real and Sham) in Patients With Pelvic Pain(2 weeks)
- Patient Global Assessment - PGA(2 weeks)
- Von Frey(baseline and at 2 weeks)
研究者
Felipe Fregni
Principal Investigator
Spaulding Rehabilitation Hospital