Treatment Efficacy of OMT for Carpal Tunnel Syndrome

在美国，成人腕管综合征(CTS)的发病率从15%到20%不等，具体取决于 研究，每年在医疗保健上花费超过10亿美元。CTS的手术占了很大一部分 这些成本高达三分之一的患者术后再次出现症状。 这项拟议的探索性临床试验的总体目标是评估一种保守的、 作为CTS标准护理的辅助治疗的手法治疗。这项初步研究利用了一种 前瞻性、随机、安慰剂对照临床试验方法学检查8周 骨科手法治疗(OMT)与标准治疗相结合的治疗方案 将对症状、功能限制和生理方面产生直接和持久的积极影响 与CTS相关的损害。年龄在20岁到65岁之间的男性和女性 电生理和症状/功能纳入标准将随机分配到以下三项研究之一 团体，所有这些团体都将继续与其治疗医生/提供者进行标准医疗护理；(I)OMT PLUS 标准医疗；(2)安慰剂(亚治疗性超声波)加标准医疗；和(3) 仅限标准医疗护理(不治疗)。观察指标为：1.正中和尺骨运动及感觉 神经传导波幅和远端潜伏期，2。症状和功能状态，3。力量，4。 感觉，5.腕管的内部尺寸，以及6.水的量化(MRI信号强度) (水肿)正中神经和腕管。安慰剂的效力和盲目的成功将被评估。一个 初步调查表明，我们有能力招募受试者并衡量这些结果。电源 基于平均正中运动神经末端潜伏期减少30%的分析确定了最小的 每组42名受试者。预计将有更多的主题在 OMT辅助治疗组神经潜伏期较其他治疗组有明显改善 两个治疗组。预计OMT辅助治疗组也将有更大的 各项生理及临床转归指标改善情况均优于其他两组。这是意料之中的 这项初步临床试验的结果将为多中心的发展提供基础 临床试验比较保守非手术手法治疗与非手术治疗的结果 CTS的外科治疗结果。

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.