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

Mayo Clinic11 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carpal Tunnel Syndrome Bilateral

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 and pinch

Use dynameters and pinch meters

Time frame: 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.

Time frame: Change from Baseline to 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes