A Comparison of Incisionless Ultrasound Guided Thread Carpal Tunnel Release and Mini Open Carpal in Patients With Bilateral Carpal Tunnel Syndrome

Study Overview
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Brief Summary
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To compare the incisionless thread carpal tunnel release with the standard mini-open carpal tunnel release (standard of care) in patients with bilateral carpal tunnel syndrome. Patients with bilateral CTS will have one side released with incisionless thread carpal tunnel release and the contralateral side released with the mini-open carpal tunnel release. The investigators hypothesize that the incisionless thread carpal tunnel release (TCTR) will be no different than the standard mini-open release (MOR) with regard to symptom improvement and safety and will be less painful, result in quicker return to work and will be less costly.

Official Title
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A Prospective Comparison of Incisionless Ultrasound Guided Thread Carpal Tunnel Release and Mini Open Carpal in Patients With Bilateral Carpal Tunnel Syndrome: A Transform the Practice Study

Conditions
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Carpal Tunnel Syndrome Bilateral

Intervention / Treatment
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* Procedure: Carpal Tunnel Procedure (open)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of bilateral CTS with symptoms including pain, paresthesia's, and weakness of the hand in the median nerve distribution for minimum of 3 months Willingness to undergo bilateral carpal tunnel surgical treatment with one side having the TCTR and the other a mini open carpal tunnel release Age 18-65 years of age Clinical examination findings (compression test, Tinels, Phalens, etc) consistent with carpal tunnel syndrome. 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 Able and willing to complete all follow-up appointments Exclusion Criteria: Previous CTS surgical release on any of their hands Diabetes mellitus Hypothyroidism Significant Hand arthritis (rheumatologic or osteoarthritis) Pregnancy Electromyographic evidence of any condition other than CTS affecting the hand Workman's compensation

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: Dominant hand-open Carpal Tunnel Release<br>Standard mini-open carpal tunnel release (standard of care) on the dominant hand. | Procedure: Carpal Tunnel Procedure (open)<br>* Patients with bilateral CTS will have one side released with incisionless thread carpal tunnel release and the contralateral side released with the mini-open carpal tunnel release.<br>* Other names: Carpal Tunnel Procedure (Incisionless);|
| Other: Dominant hand-Incisionless thread carpal tunnel release<br>Incisionless thread carpal tunnel release on the dominant hand. | Procedure: Carpal Tunnel Procedure (open)<br>* Patients with bilateral CTS will have one side released with incisionless thread carpal tunnel release and the contralateral side released with the mini-open carpal tunnel release.<br>* Other names: Carpal Tunnel Procedure (Incisionless);|

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 | Change from Baseline to 12 months | 
| Visual analog pain scale | Pain that participant is currently experiencing the in the hand or risk(0-100) | Change from Baseline to 12 months | 
| Strength testing of grip and pinch | Use dynameters and pinch meters | Change from Baseline to 12 months | 
| Disability of the Arm Shoulder Hand DASH | he 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. | Change from Baseline to 12 months |