NEUROMUSCULAR CONDITION THERAPY-DYSSYNERGIC DEFECATION

神经肌肉状况治疗-不协同排便

• 批准号: 6517713
• 负责人: Satish SC Rao
• 金额: $ 25.28万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-01 至 2005-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6517713
• 关键词: alternative medicine; behavior therapy; behavioral /social science research tag; behavioral medicine; biofeedback; clinical research; clinical trials; constipation; dietary control; gastrointestinal disorder chemotherapy; gastrointestinal motility /pressure; habits; health behavior; health care cost /financing; home health care; human subject; human therapy evaluation; laxative; nutrition related tag; personal log /diary; quality of life; alternative medicine; behavior therapy; behavioral /social science research tag; behavioral medicine; biofeedback; clinical research; clinical trials; constipation; dietary control; gastrointestinal disorder chemotherapy; gastrointestinal motility /pressure; habits; health behavior; health care cost /financing; home health care; human subject; human therapy evaluation; laxative; nutrition related tag; personal log /diary; quality of life

Constipation affects 4 million Americans, predominantly women and the elderly. Its pathophysiology is incompletely understood and its treatment is unsatisfactory. Laxative-dependent, and unable to accomplish natures' call, many resort to desperate treatments. About 50 percent of patients with constipation exhibit uncoordinated or dyssynergic defecation. Uncontrolled studies suggest that biofeedback therapy may improve symptoms in these patients. But, whether the improvement is due to the behavioral intervention or a consequence of excess attention is not known. Biofeedback therapy is labor-intensive, expensive and only available in a few centers. In order to treat the many patients in the community, a home-based, self-training program is essential. Our proposal addresses three objectives; 1) to determine the efficacy of biofeedback therapy by performing a randomized controlled study in patients with dyssynergic defecation. After diagnostic evaluation with colon transit study, anorectal manometry and stool diaries, 90 patients will be randomized to receive standard treatment consisting of diet, habit-training and laxatives or biofeedback therapy consisting of neuromuscular conditioning or sham feedback therapy. Short-term (3 month) and long-term (12 month) assessments of anorectal physiology-defecation index, anal relaxation, fecom expulsion time and colon transit time and symptomatology-bowel satisfaction score, straining effort, laxative consumption score and stool form and consistency will be performed. 2) To investigate the efficacy of home-training versus office-based biofeedback therapy and if it is cost-effective, 100 patients will be randomized to receive either home-training using a hand-held portable device and a silicon probe or biofeedback therapy for 3 months. Anorectal physiology and symptoms will be assessed and actuarial costs of each treatment will be compared. 3) For a condition that is entwined with psyche there is no information on quality of life or psychosocial function. We wish to investigate these parameters with validated instruments, SF-36 and SCL-90-R in 90 patients, before and after treatment and compare this with two controlled groups. This may provide impetus for new treatments such as psychotherapy. This first controlled study will determine the efficacy and scientific basis for a safe and alternative therapy for difficult defecation, provide new information that could facilitate home self-training and assess the impact of treatment on anorectal physiology, symptoms, quality of life and psychosocial aspects.

便秘影响400万美国人，主要是妇女和老年人。 它的病理生理学尚不完全理解，治疗不令人满意。 许多依赖于泻药，无法完成自然的呼吁，许多人求助于绝望的治疗。便秘患者中约有50％表现出不协调或同性恋的排便。 不受控制的研究表明，生物反馈疗法可以改善这些患者的症状。 但是，不知道改善是由于行为干预造成的还是过度关注的结果。生物反馈疗法是劳动密集型，昂贵的，仅在几个中心可用。 为了治疗社区中的许多患者，基于家庭的自我训练计划至关重要。 我们的提案针对三个目标； 1）通过对患有患有障碍的患者进行随机对照研究来确定生物反馈疗法的疗效。 通过结肠运输研究，厌食直肠体测量和粪便日记进行诊断评估后，将随机分配90名患者，以接受包括饮食，习惯训练和泻药或生物反馈治疗的标准治疗，包括神经肌肉调理或假反馈治疗。 短期（3个月）和长期（12个月）评估厌食生理学 - 缺失指数，肛门放松，粪便驱动时间以及结肠传输时间和症状 - 孔孔的满意度，紧张的努力，宽松的消耗量和粪便形式和粪便形式和一致性。 2）研究家庭培训与基于办公室的生物反馈疗法的疗效，如果具有成本效益，将有100名患者随机分配使用手持式便携式设备，硅探测器或生物反馈治疗3个月。将评估肛门直肠生理和症状，并将每种治疗的精算成本进行比较。 3）对于与心理纠缠的条件，没有有关生活质量或社会心理功能的信息。 我们希望在90名患者中使用经过验证的仪器，SF-36和SCL-90-R研究这些参数，并在治疗前后，并将其与两个受控组进行比较。 这可能为新疗法（例如心理疗法）提供动力。 这项第一次对照研究将确定用于难以排便的安全和替代疗法的疗效和科学基础，提供可以促进家庭自我训练的新信息，并评估治疗对厌食生理学，症状，生活质量和心理社会方面的影响。