Carpal Tunnel Syndrome
Conditions
Brief summary
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.
Interventions
PROCEDUREIncisionless Threaded Carpal Tunnel
ultra-minimally invasive thread carpal tunnel release
PROCEDUREStandard Mini-Open Carpal Tunnel
open surgical 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) functional score | Time Frame: 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 | Time Frame: Change from Baseline to 12 months | Pain that participant is currently experiencing the in the hand or risk(0-100) |
| Strength testing of grip | Time Frame: Change from Baseline to 12 months | Use dynameters |
| Disability of the Arm Shoulder Hand DASH | Time Frame: Change from Baseline to 12 months | 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. |
| Strength testing of pinch | Time Frame: Change from Baseline to 12 months | Use pinch meters |
Countries
United States
Outcome results
None listed