A Comparison of Incisionless Ultrasound Guided Thread Carpal Tunnel Release and Mini Open Carpal in Patients With Bilateral Carpal Tunnel Syndrome
- Conditions
- Carpal Tunnel Syndrome Bilateral
- Interventions
- Procedure: Carpal Tunnel Procedure (open)
- Registration Number
- NCT03906604
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dominant hand-Incisionless thread carpal tunnel release Carpal Tunnel Procedure (open) Incisionless thread carpal tunnel release on the dominant hand. Dominant hand-open Carpal Tunnel Release Carpal Tunnel Procedure (open) Standard mini-open carpal tunnel release (standard of care) on the dominant hand.
- Primary Outcome Measures
Name Time Method Visual analog pain scale Change from Baseline to 12 months Pain that participant is currently experiencing the in the hand or risk(0-100)
Disability of the Arm Shoulder Hand DASH Change from Baseline to 12 months 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 in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) functional score Change from Baseline to 12 months Measured on a symptom severity scale from 1 to 5, where 1 is normal and 5 is very serious/continued/difficult
Strength testing of grip and pinch Change from Baseline to 12 months Use dynameters and pinch meters
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States