Treatment Efficacy of OMT for Carpal Tunnel Syndrome

描述（由申请人提供）：根据研究，美国成人腕管综合征（CTS）的发病率为15-20%，每年的医疗费用超过10亿美元。CTS的手术占这些费用的大部分，其中多达三分之一的患者在术后再次出现症状。这项拟议的探索性临床试验的总体目标是评价保守的手动药物治疗作为CTS标准治疗的替代疗法的疗效。本初步研究采用前瞻性、随机、安慰剂对照临床试验方法，以检查8周的整骨手法治疗（OMT）治疗方案在与标准治疗交替使用时是否对CTS相关的症状、功能限制和生理损害具有立即和持久的积极影响。将符合电生理和症状/功能入选标准的年龄在20岁至65岁之间的男性和女性受试者随机分配至三个研究组之一，所有研究组将继续由其治疗医生/提供者进行标准医疗护理;（i）OMT加标准医疗护理;（ii）安慰剂（亚治疗超声）加标准医疗护理;和（iii）仅标准医疗护理（不治疗）。结果措施是：1。正中和尺侧运动和感觉神经传导幅度和远端桡神经，2。症状和功能状态，3。力量，4。感觉，5。腕管的内部尺寸，和6。正中神经和腕管中水（水肿）的定量（MRI信号强度）。将评价安慰剂效价和设盲成功率。初步调查表明，我们有能力招募受试者并衡量这些结果。基于平均正中运动神经远端潜伏期降低30%的把握度分析确定每个治疗组至少有42例受试者。预计与其他两个治疗组相比，OMT连续治疗组中显著更多数量的受试者将实现神经潜伏期的有效变化。还预期OMT连续治疗组将比其他两组在所有生理和临床结果测量方面具有更大的改善。预计该初步临床试验的结果将为开展多中心临床试验提供基础，以比较CTS保守非手术手动药物治疗与手术治疗的结局。

DESCRIPTION (provided by applicant): The incidence of Carpal Tunnel Syndrome (CTS) in adults in the U.S. ranges from 15-20% depending on the study, and costs over one billion dollars annually in medical care. Surgery for CTS accounts for much of these costs with up to one third of these patients experiencing re-occurrence of symptoms post-operatively. The overall goal for this proposed exploratory clinical trial is to evaluate the efficacy of a conservative, manual medicine treatment as an adjunctive therapy to standard care for CTS. This pilot study utilizes a prospective, randomized, placebo-controlled clinical trial methodology to examine whether an eight week treatment regimen of osteopathic manipulative treatment (OMT) when used adjunctively to standard therapy will have immediate and lasting positive effects on the symptoms, functional limitations, and physiologic impairment associated with CTS. Male and female subjects between the ages of 20 and 65 who meet electro-physiologic and symptom/functional inclusion criteria will be randomly assigned to one of three study groups, all of which will continue standard medical care with their treating physician/provider; (i) OMT plus standard medical care; (ii) placebo (sub-therapeutic ultrasound) plus standard medical care; and (iii) standard medical care only (no-treat). Outcome measures are: 1. Median and Ulnar motor and sensory nerve conduction amplitudes and distal latencies, 2. Symptoms and Functional status, 3. Strength, 4. Sensation, 5. Interior dimensions of the carpal tunnel, and 6. Quantification (signal intensity by MRI) of water (edema) in the Median nerve and carpal tunnel. Placebo potency and blinding success will be evaluated. A preliminary investigation demonstrates our ability to recruit subjects and measure these outcomes. Power analysis based upon a decrease in the mean median motor nerve distal latency of 30% identified a minimum number of 42 subjects per treatment group. It is expected that a significantly greater number of subjects in the OMT adjunctive treatment group will achieve the effective change in nerve latency compared to the other two treatment groups. It is also expected that the OMT adjunctive treatment group will have greater improvement of all physiological and clinical outcome measures than the other two groups. It is anticipated that the findings of this preliminary clinical trial will provide a basis for the development of a multi-center clinical trial to compare the outcomes of conservative non-surgical manual medicine treatments with the outcomes of surgical treatments of CTS.