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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Other: Osteopathic manipulative treatment (OMT)
* Other: Conservative treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of unilateral or bilateral mild to moderate carpal tunnel syndrome, based on recent EMG findings Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - OMT Only<br>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. | Other: Osteopathic manipulative treatment (OMT)<br>* Two osteopathic primary care physicians will performing osteopathic manipulative techniques with a minimum of three direct techniques focused on carpal tunnel. These techniques will include the interosseous membrane technique, the flexor retinaculum soft tissue technique, and the radiocarpal somatic dysfunction technique. They will also evaluate and treat the cervical spine, with particular attention to the C5-7 levels, all the way to the wrist and hand as they see fit based on the findings of their osteopathic structural exam.<br>|
| Active Comparator: Group 2 - OMT + Conservative Treatment<br>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. | Other: Osteopathic manipulative treatment (OMT)<br>* Two osteopathic primary care physicians will performing osteopathic manipulative techniques with a minimum of three direct techniques focused on carpal tunnel. These techniques will include the interosseous membrane technique, the flexor retinaculum soft tissue technique, and the radiocarpal somatic dysfunction technique. They will also evaluate and treat the cervical spine, with particular attention to the C5-7 levels, all the way to the wrist and hand as they see fit based on the findings of their osteopathic structural exam.<br>Other: Conservative treatment<br>* Conservative therapy will be defined as including the use of splints, NSAIDs, opioids, and therapeutic injection of the carpal tunnel with steroids. Physical therapy will be excluded from the conservative therapy regimen.<br>|
| Active Comparator: Group 3 - Conservative Treatment Only<br>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. | Other: Conservative treatment<br>* Conservative therapy will be defined as including the use of splints, NSAIDs, opioids, and therapeutic injection of the carpal tunnel with steroids. Physical therapy will be excluded from the conservative therapy regimen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elasticity of median nerve at the carpal tunnel inlet | Measured by shear wave elastography. | baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment | 
| Cross-sectional area of median nerve in 3 locations | Measured by real-time grayscale ultrasound | baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment | 
| Quick DASH Patient Survey Score | 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. | Completed at treatment visits (initial, 2 weeks, 4 weeks, and 6 weeks) | 
| CTS-6 Evaluation Tool Score | 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. | Completed at treatment visits (initial, 2 weeks, 4 weeks, and 6 weeks) | 
| Elasticity of the transverse carpal ligament | Measured by shear wave elastography. | baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment | 
| Elasticity of the subsynovial connective tissue in the carpal tunnel | Measured by shear wave elastography. | baseline, post 2-week treatment, post 4-week treatment, post 6-week treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Distal Latency | Time it takes for an impulse to traverse the segment nearest the muscle. | Baseline and at 8 weeks (end of study) | 
| Sensory Distal Latency | Time it takes for an impulse to traverse the segment nearest the muscle. | Baseline and at 8 weeks (end of study) |