Ultrasound Guided - Incisionless Threaded Carpal Tunnel Release

Study Overview
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Brief Summary
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The overarching long-term goal is to develop a CTS Treatment Center within the Hand Clinic that offers a variety of established and emerging treatment options in a multidisciplinary program. The ultra-minimally invasive carpal tunnel release would be one component of the program. Furthering the knowledge with regard to ultra-minimally invasive carpal tunnel release outcomes would facilitate the Hand Clinics ability to offer this procedure as a component of individualized care in the CTS Treatment Center to facilitate delivery of the appropriate level of care to the right patient.

Official Title
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Ultrasound Guided - Incisionless Thread Carpal Tunnel Release Versus Standard Mini-Open Carpal Tunnel Release for the Treatment of Carpal Tunnel Syndrome: A Randomized Trial

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Procedure: Incisionless Threaded Carpal Tunnel
* Procedure: Standard Mini-Open Carpal Tunnel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of CTS with symptoms including pain, paresthesia's, and weakness of the hand in the median nerve distribution for minimum of 3 months Age 18-65 years old Persistence of symptoms after 6 weeks of conservative treatment such as splinting, activity modification, and/or injection therapy. Electromyographic evidence of mild, moderate, moderately severe, or severe median nerve neuropathy at the wrist Ability to complete all follow up appointments Exclusion Criteria: Previous CTS surgical release on affected side Diabetes mellitus Hypothyroidism Hand arthritis (rheumatologic or osteoarthritis) Pregnancy Electromyographic evidence of any condition other than CTS affecting the hand Workman's compensation Participants not willing to make follow-up visits

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 |
| --- | --- |
| Other: Incisionless Threaded Carpal Tunnel<br> | Procedure: Incisionless Threaded Carpal Tunnel<br>* ultra-minimally invasive thread carpal tunnel release<br>Procedure: Standard Mini-Open Carpal Tunnel<br>* open surgical carpal tunnel release<br>|
| Other: Standard Mini-Open Carpal Tunnel<br> | Procedure: Incisionless Threaded Carpal Tunnel<br>* ultra-minimally invasive thread carpal tunnel release<br>Procedure: Standard Mini-Open Carpal Tunnel<br>* open surgical carpal tunnel release<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) functional score | Measured on a symptom severity scale from 1 to 5, where 1 is normal and 5 is very serious/continued/difficult | Time Frame: Change from Baseline to 12 months | 
| Visual analog pain scale | Pain that participant is currently experiencing the in the hand or risk(0-100) | Time Frame: Change from Baseline to 12 months | 
| Strength testing of grip | Use dynameters | Time Frame: Change from Baseline to 12 months | 
| Disability of the Arm Shoulder Hand DASH | The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. The main purpose of this study was to assess the longitudinal construct validity of the DASH among patients undergoing surgery. The second purpose was to quantify self-rated treatment effectiveness after surgery. | Time Frame: Change from Baseline to 12 months | 
| Strength testing of pinch | Use pinch meters | Time Frame: Change from Baseline to 12 months |