Ultrasound Guided - Incisionless Threaded Carpal Tunnel Release

N/ACompletedNCT04101955

Mayo Clinic12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carpal Tunnel Syndrome

Interventions

Incisionless Threaded Carpal TunnelPROCEDURE

ultra-minimally invasive thread carpal tunnel release

Standard Mini-Open Carpal TunnelPROCEDURE

open surgical carpal tunnel release

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

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