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

NCT03476486 | Completed Phase 2 DMC

• 1 other identifier: Pro00060817
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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 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

Outcome Measures

Primary Outcomes (7)

• Early recovery

  At weekly intervals for the 1st month ,each subject will also be contacted to report on their recovery (return to everyday activities including work) and any adverse effects/complications

  1st month following the thread carpal tunnel release surgery

• Boston Carpal Tunnel Questionnaire

  subjective measure of symptom and functional limitation severity. Symptom and function subscale scores were summed (score range 2-10 with 2=asymptomatic and 10=severely symptomatic).

  a month prior to and at 3 and 6 months post procedure

• Hand sensation

  monofilament hand sensibility testing

  a month prior to and at 3 and 6 months post procedure

• grip and pinch strength

  Grip strength measured using a hand grip dynamometer; pinch strength measured with a pinch dynamometer

  a month prior to and at 3 and 6 months post procedure

• Median nerve cross-sectional area

  median nerve cross-sectional area measurement at the carpal tunnel inlet using ultrasound

  a month prior to and at 3 and 6 months post procedure

• Median nerve electrophysiologic function

  electrophysiologic function of the median nerve across the carpal tunnel (motor and sensory conduction velocities and amplitudes).

  a month prior to and at 3 and 6 months post procedure

• Subject satisfaction

  Global satisfaction score

  3 and 6 months post thread carpal tunnel release

Study Arms (2)

Treatment

EXPERIMENTAL

The hand that was subject to thread carpal tunnel release surgery

Procedure: Thread carpal tunnel release

Control

NO INTERVENTION

The hand that was not treated

Interventions

Thread carpal tunnel release PROCEDURE

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Robert Burnham

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single blind masking (assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: controlled interventional clinical trial

Study Record Dates

• First Submitted: March 17, 2018
• First Posted: March 26, 2018
• Study Start: May 20, 2016
• Primary Completion: January 20, 2018
• Study Completion: January 20, 2018
• Last Updated: May 9, 2023

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share