Status:

COMPLETED

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

Lead Sponsor:

University of Alberta

Conditions:

Carpal Tunnel Syndrome

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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 numb...

Detailed Description

Objectives: to evaluate the effectiveness and safety of a minimally invasive ultrasound-guided looped thread technique of carpal tunnel release Background: Carpal tunnel syndrome (CTS) is the most co...

Eligibility Criteria

Inclusion

  • \>18 years of age
  • symptoms (hand numbness, tingling, weakness or pain; symptom aggravation with repetitive or sustained gripping; nocturnal symptom exacerbation) and signs (hand sensory disturbance or weakness; positive median nerve Tinel's sign or Phalen's test) compatible with carpal tunnel syndrome
  • symptom duration \>3 months refractory to conservative treatment (i.e. wrist splints, activity modification, NSAID, +/- intracarpal tunnel corticosteroid injection)
  • nerve conduction study abnormalities compatible with moderate to severe median neuropathy at the carpal tunnel (motor and sensory conduction slowing across the carpal tunnel +/- evidence of axonal loss)
  • signed informed consent

Exclusion

  • ultrasound identifies a bifid median nerve or persistent median artery at the carpal tunnel inlet
  • Clinical or electrophysiologic evidence of a neurologic disorder of the upper extremity besides carpal tunnel syndrome (i.e. proximal median neuropathy; ulnar or radial neuropathy, brachial plexopathy, cervical radiculopathy or generalized polyneuropathy)
  • Inability to understand the informed consent or the Boston Carpal Tunnel Questionnaire
  • Coagulopathy or anticoagulation that cannot be stopped for the carpal tunnel release procedure
  • Local anesthetic allergy
  • systemic infection or a local infection at the procedure site

Key Trial Info

Start Date :

May 20 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 20 2018

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT03476486

Start Date

May 20 2016

End Date

January 20 2018

Last Update

May 9 2023

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