MedTrace Logo

A Pilot Study to Evaluate the Effectiveness of Ultrasound Guided Looped Thread Carpal Tunnel Release

NCT03476486 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-05-09

No results posted yet for this study

Summary

Carpal tunnel syndrome occurs when a nerve gets pinched as it passes through a confined tunnel within the wrist and hand. It is the most commonly pinched nerve and often results in disabling hand numbness, tingling, pain and weakness. For moderate and severe cases, an operation is often performed that cuts the ligament that presses on the nerve. This surgery is generally very successful but involves a 2-5 cm long incision at the base of the palm. Recovery from the surgery usually takes 3-8 weeks. Ultrasound provides a clear noninvasive way of looking at the contents of the carpal tunnel. A technique has been developed whereby a wire thread is looped around the ligament using a needle guided by ultrasound. The ligament is cut by the wire below the surface of the skin. This technique results in 2 needle puncture holes instead of the open incision of the traditional surgery. The investigators have completed research on this technique in cadavers. It was confirmed that complete or almost complete cutting of the ligament can be safely and predictably accomplished. This research will look at the effectiveness of this looped thread technique of carpal tunnel release on patients who have carpal tunnel syndrome. Specifically, participants will be required to: 1. rate the severity of their carpal tunnel syndrome symptoms and disability using a standard questionnaire, 2. measure hand sensation, 3. measure pinch and grip strength tests of their hands, 4. undergo ultrasound measurements of the size of the pinched nerve at the carpal tunnel, and 5. undergo electrical tests to measure the nerves ability to conduct impulses across the carpal tunnel. These will be measured before the looped wire procedure and at 3 and 6 months following the procedure. Recovery time will also be measured.

Conditions

  • Carpal Tunnel Syndrome

Interventions

PROCEDURE

Thread carpal tunnel release

Ultrasound-guided percutaneous minimally invasive thread carpal tunnel release using a looped thread technique

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Robert Burnham · University of Alberta

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-20
Primary Completion
2018-01-20
Completion
2018-01-20

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03476486 on ClinicalTrials.gov