A Pilot Feasibility Study of Physical Therapy for the Treatment of Urologic Pelvic Pain Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 10
- 主要终点
- Number consenting to join study out of eligible patients approached
研究概览
简要总结
The purpose of this study is to determine if a randomized trial of physical therapy for pelvic pain is feasible.
详细描述
This is a pilot study wherein eligible participants will be randomly assigned to receive either myofascial tissue manipulation or global therapeutic massage. Those receiving myofascial tissue manipulation will have targeted internal and external connective tissue manipulation focusing on the muscles and connective tissues of the pelvic floor, hip girdle, and abdomen. Those receiving global therapeutic massage will have non-specific somatic treatment with full-body Western massage.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •female and male patients who have failed to respond to previous therapies for interstitial cystitis/painful bladder syndrome
- •male patients who have failed to respond to previous therapies for chronic prostatitis/chronic pelvic pain syndrome
排除标准
- •neurologic disorder affecting bladder
- •bladder cancer, prostate cancer, or urethral cancer
结局指标
主要结局
Number consenting to join study out of eligible patients approached
时间窗: 6 months
This study will recruit both female and male patients who have failed to respond to previous therapies for either Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) or male patients who have failed to respond to previous therapies for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS).
Number of times therapists adhered to prescribed therapeutic protocol
时间窗: 12 weeks
For each therapy session therapy records are reviewed to determine whether the therapist followed the therapeutic protocol. Each therapy session is scored as adherent or non-adherent and the number of adherent sessions are recorded per participant
次要结局
- Global response assessment (GRA) Global response assessment(12 weeks)
- Tolerability of treatment measured by number of treatment sessions participants completed(12 weeks)
- Number of adverse events reported by the participants(12 weeks)