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Completed

NCT Number: NCT04101955

Ultrasound Guided - Incisionless Threaded Carpal Tunnel Release

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55901, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Incisionless Threaded Carpal Tunnel

Procedure

ultra-minimally invasive thread carpal tunnel release

Standard Mini-Open Carpal Tunnel

Procedure

open surgical carpal tunnel release

Primary outcomes

  1. Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) functional score

    Time frame: Time Frame: Change from Baseline to 12 months

    Measured on a symptom severity scale from 1 to 5, where 1 is normal and 5 is very serious/continued/difficult

  2. Visual analog pain scale

    Time frame: Time Frame: Change from Baseline to 12 months

    Pain that participant is currently experiencing the in the hand or risk(0-100)

  3. Strength testing of grip

    Time frame: Time Frame: Change from Baseline to 12 months

    Use dynameters

  4. Disability of the Arm Shoulder Hand DASH

    Time frame: Time Frame: Change from Baseline to 12 months

    The 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.

  5. Strength testing of pinch

    Time frame: Time Frame: Change from Baseline to 12 months

    Use pinch meters

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Ultrasound Guided - Incisionless Thread Carpal Tunnel Release Versus Standard Mini-Open Carpal Tunnel Release for the Treatment of Carpal Tunnel Syndrome: A Randomized Trial

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Sep 24, 2019
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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