Treatment Efficacy of OMT for Carpal Tunnel Syndrome

描述（由申请人提供）：美国成人腕管综合征（CTS）的发病率在15-20%之间，具体取决于研究，每年的医疗费用超过10亿美元。CTS的手术费用占这些费用的大部分，其中多达三分之一的患者在手术后再次出现症状。这项探索性临床试验的总体目标是评估保守的手工药物治疗作为CTS标准治疗的辅助治疗的疗效。本初步研究采用前瞻性、随机、安慰剂对照的临床试验方法，研究8周的骨疗法手法治疗（OMT）作为标准治疗的辅助疗法，是否会对CTS相关的症状、功能限制和生理损伤产生即时和持久的积极影响。年龄在20至65岁之间、符合电生理和症状/功能纳入标准的男性和女性受试者将被随机分配到三个研究小组之一，所有这些研究小组都将继续接受其主治医生/提供者的标准医疗护理；(i) OMT加标准医疗；㈡安慰剂（亚治疗性超声）加标准医疗护理；（三）仅提供标准医疗服务（不提供治疗）。结果衡量标准为：1。2.正中和尺侧运动和感觉神经传导振幅和远端潜伏期。3.症状与功能状态。力量,4。感觉,5。腕管的内部尺寸，6。正中神经和腕管积水（水肿）定量（MRI信号强度）。将评估安慰剂效力和致盲效果。初步调查表明我们有能力招募研究对象并衡量这些结果。基于平均运动神经远端潜伏期减少30%的功率分析确定了每个治疗组最少42名受试者。预计与其他两个治疗组相比，OMT辅助治疗组实现神经潜伏期有效改变的受试者数量明显更多。预计OMT辅助治疗组比其他两组在所有生理和临床结果指标上有更大的改善。预计本初步临床试验结果将为开展多中心临床试验，比较CTS保守性非手术手工药物治疗与手术治疗的疗效提供基础。

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.