Carpal Tunnel Syndrome Bilateral
Conditions
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.
Interventions
PROCEDURECarpal Tunnel Procedure (open)
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Visual analog pain scale | Change from Baseline to 12 months | Pain that participant is currently experiencing the in the hand or risk(0-100) |
| Strength testing of grip and pinch | Change from Baseline to 12 months | Use dynameters and pinch meters |
| 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. |
Countries
United States
Outcome results
None listed