Treatment Efficacy of OMT for Carpal Tunnel Syndrome

OMT治疗腕管综合症的疗效

• 批准号: 7406046
• 负责人: DES ANGES CRUSER
• 金额: $ 16.89万
• 依托单位: UNIVERSITY OF NORTH TEXAS HLTH SCI CTR
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7406046
• 关键词: Accounting; Address; Adult; Age; Area; Articular Range of Motion; Burn injury; Caring; Carpal Tunnel Syndrome; Characteristics; Cicatrix; Clinical; Clinical Trials; Condition; Controlled Clinical Trials; Data; Development; Diagnosis; Dimensions; Distal; Drainage procedure; Edema; Ensure; Esthesia; Female; Fingers; Goals; Hand; Human body; Impairment; Incidence; Injury; Investigation; Limb structure; Liquid substance; Magnetic Resonance Imaging; Manuals; Measures; Medical; Medicine; Methodology; Motor; Multi-Institutional Clinical Trial; Musculoskeletal; Neck; Nerve; Neural Conduction; Neurologic; Numbers; Operative Surgical Procedures; Osteopathic manipulation; Outcome; Outcome Measure; Pain; Paresthesia; Patients; Physicians; Physiological; Pilot Projects; Placebo Control; Placebos; Population; Prevalence; Process; Provider; Prunella vulgaris; Randomized; Range; Range of motion exercise; Rate; Recruitment Activity; Reporting; Research Personnel; Risk; Severities; Shoulder; Signal Transduction; Speed; Standards of Weights and Measures; Structure; Symptoms; Testing; Therapeutic; Treatment Efficacy; Treatment Protocols; Ultrasonography; Upper arm; Water; Week; Wrist; afferent nerve; base; cost; design; experience; functional status; grasp; improved; inclusion criteria; male; median nerve; programs; prospective; success

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.

腕管综合征（CTS）的发病率在美国成人中的范围从15-20%取决于年龄。 每年花费超过10亿美元用于医疗保健。CTS的手术占了大部分 这些患者中有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， 手动药物治疗作为CTS标准护理的连续治疗。这项试点研究利用了 前瞻性、随机化、安慰剂对照临床试验方法，以检查8周 与标准治疗配合使用时的整骨手法治疗（OMT）治疗方案 将对症状、功能限制和生理功能产生立即和持久的积极影响。 与CTS相关的损伤。年龄在20至65岁之间的男性和女性受试者， 电生理和症状/功能入选标准将被随机分配到三项研究之一 组，所有这些人都将继续与他们的治疗医生/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。正中和尺骨运动和感觉 神经传导幅度和远端桡动脉，2.症状和功能状态，3。力量，4。 感觉，5。腕管的内部尺寸，和6。水的定量（MRI信号强度） 正中神经和腕管水肿。将评价安慰剂效价和设盲成功率。一 初步调查表明我们有能力招募受试者并衡量这些结果。功率 基于平均正中运动神经远端潜伏期减少30%的分析确定了最小 每个治疗组42例受试者。预计， OMT连续治疗组较对照组能有效改变神经潜伏期 两个治疗组。还预期OMT连续治疗组将具有更大的 所有生理和临床结果指标均优于其他两组。预计 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，比较保守的非手术手动药物治疗与 CTS手术治疗的结果。