Pilot Study Evaluating the Elasticity and Shear Wave Modulus (Stiffness) of the Median Nerve in Patients With Mild to Moderate Idiopathic Carpal Tunnel Syndrome Receiving OMT and Conservative Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Cross-sectional area of median nerve in 3 locations
研究概览
简要总结
To evaluate and quantify changes in the elasticity and shear wave modulus (stiffness) of the median nerve in patients diagnosed with mild to moderate carpal tunnel syndrome following osteopathic manipulative therapy.
详细描述
This small pilot study aimed to investigate whether the imaging modality known as shear wave elastography (SWE) could be used to objectively quantify post treatment changes in the soft tissues of the carpal tunnel as a result of Osteopathic Manipulative Therapy (OMT) in patients with mild to moderate-severe carpal tunnel syndrome (CTS). Patients were randomly assigned into three treatment groups for six weeks: OMT only, traditional conservative care (ie. splits and steroid injections), or a combination of both OMT and conservative therapy.
The primary outcome was to evaluate the stiffness of the median nerve, the transverse carpal ligament and the intra-carpal tunnel contents. Our team also used traditional grayscale ultrasound to measure the cross-sectional diameter of the nerve as well as the standard, often uncomfortable, electromyography (EMG) test to assess pre- and post-treatment nerve function. Patient outcomes were tracked using both patient surveys which captured a participant's symptoms and level of function as well as clinician assessment tools. Osteopathic Manipulative Treatment (OMT) was a treatment technique used involving a hands-on exam to diagnose, prevent, and treat various musculoskeletal conditions by addressing structural imbalance in the body's bones and soft tissues. Those subjects in the conservative therapy only group were treated with splint and steroid injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of unilateral or bilateral mild to moderate carpal tunnel syndrome, based on recent EMG findings
排除标准
- •History of undergoing recent physical therapy for treatment of carpal tunnel syndrome
- •History of wrist trauma or surgery
- •Hypothyroidism
- •Severe CTS that has progressed to muscle atrophy
- •Systemic disease or condition including but not limited to diabetes mellitus, thyroid disorders, rheumatoid disorders, Paget's bone disease, gout, myxedema, multiple myeloma, acromegaly, hepatic disease, dialysis patients, or other diseases or conditions in which peripheral neuropathies are common.
- •Secondary cause of CTS such as a ganglion cyst, mass, or an accessory muscle shown by US or MRI of the affected wrist.
- •Bifid median nerve as shown by US or MRI of the affected wrist
- •pregnant or recently postpartum
研究组 & 干预措施
Group 1 - OMT Only
Osteopathic manipulative treatment will include the interosseous membrane technique, the flexor retinaculum soft tissue technique, and the radiocarpal somatic dysfunction technique. The cervical spine will also be treated, with particular attention to the C5-7 levels, all the way to the wrist and hand as the physician sees fit based on the findings of the osteopathic structural exam.
干预措施: Osteopathic manipulative treatment (OMT) (Other)
Group 2 - OMT + Conservative Treatment
Will receive Osteopathic manipulative treatment in addition to conservative treatment. Conservative therapy will be defined as including the use of splints, NSAIDs, opioids, and therapeutic injection of the carpal tunnel with steroids. Physical and Occupational therapy will be excluded from the conservative therapy regimen. Osteopathic manipulative treatment will include the interosseous membrane technique, the flexor retinaculum soft tissue technique, and the radiocarpal somatic dysfunction technique. The cervical spine will also be treated, with particular attention to the C5-7 levels, all the way to the wrist and hand as the physician sees fit based on the findings of the osteopathic structural exam.
干预措施: Osteopathic manipulative treatment (OMT) (Other)
Group 2 - OMT + Conservative Treatment
Will receive Osteopathic manipulative treatment in addition to conservative treatment. Conservative therapy will be defined as including the use of splints, NSAIDs, opioids, and therapeutic injection of the carpal tunnel with steroids. Physical and Occupational therapy will be excluded from the conservative therapy regimen. Osteopathic manipulative treatment will include the interosseous membrane technique, the flexor retinaculum soft tissue technique, and the radiocarpal somatic dysfunction technique. The cervical spine will also be treated, with particular attention to the C5-7 levels, all the way to the wrist and hand as the physician sees fit based on the findings of the osteopathic structural exam.
干预措施: Conservative treatment (Other)
Group 3 - Conservative Treatment Only
Conservative therapy will be defined as including the use of splints, NSAIDs, opioids, and therapeutic injection of the carpal tunnel with steroids. Physical and Occupational therapy will be excluded from the conservative therapy regimen.
干预措施: Conservative treatment (Other)
结局指标
主要结局
Cross-sectional area of median nerve in 3 locations
时间窗: baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment
Measured by real-time grayscale ultrasound
Elasticity of median nerve at the carpal tunnel inlet
时间窗: baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment
Measured by shear wave elastography.
Elasticity of the transverse carpal ligament
时间窗: baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment
Measured by shear wave elastography.
Elasticity of the subsynovial connective tissue in the carpal tunnel
时间窗: baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment
Measured by shear wave elastography.
Quick DASH Patient Survey Score
时间窗: Completed at treatment visits (initial, 2 weeks, 4 weeks, and 6 weeks)
This questionnaire asks the patient about their symptoms as well as their ability to perform certain activities. The QuickDASH, published in 2005 in the Journal of Bone and Joint Surgery, is a subset of 11 items from the 30-item DASH and is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
CTS-6 Evaluation Tool Score
时间窗: Completed at treatment visits (initial, 2 weeks, 4 weeks, and 6 weeks)
The Value Added by Electrodiagnostic Testing in the Diagnosis of Carpal Tunnel Syndrome completed by the clinician. A score \>12 = 0.80 probability of Carpal Tunnel Syndrome and a score \>5 = 0.25 probability of Carpal Tunnel Syndrome.
次要结局
- Sensory Distal Latency(Baseline and at 8 weeks (end of study))
- Motor Distal Latency(Baseline and at 8 weeks (end of study))