TerminatedNot Applicable

A Comparison of Incisionless Ultrasound Guided Thread Carpal Tunnel Release and Mini Open Carpal in Patients With Bilateral Carpal Tunnel Syndrome

Stopped: Difficulty recruiting for open carpal tunnel study arm

United States11 participantsStarted 2019-02-05

Plain-language summary

To compare the incisionless thread carpal tunnel release with the standard mini-open carpal tunnel release (standard of care) in patients with bilateral carpal tunnel syndrome. Patients with bilateral CTS will have one side released with incisionless thread carpal tunnel release and the contralateral side released with the mini-open carpal tunnel release. The investigators hypothesize that the incisionless thread carpal tunnel release (TCTR) will be no different than the standard mini-open release (MOR) with regard to symptom improvement and safety and will be less painful, result in quicker return to work and will be less costly.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * A diagnosis of bilateral CTS with symptoms including pain, paresthesia's, and weakness of the hand in the median nerve distribution for minimum of 3 months * Willingness to undergo bilateral carpal tunnel surgical treatment with one side having the TCTR and the other a mini open carpal tunnel release * Age 18-65 years of age * Clinical examination findings (compression test, Tinels, Phalens, etc) consistent with carpal tunnel syndrome. * 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 * Able and willing to complete all follow-up appointments Exclusion Criteria: * Previous CTS surgical release on any of their hands * Diabetes mellitus * Hypothyroidism * Significant Hand arthritis (rheumatologic or osteoarthritis) * Pregnancy * Electromyographic evidence of any condition other than CTS affecting the hand * Workman's compensation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Change from Baseline to 12 months

Visual analog pain scale

Timeframe: Change from Baseline to 12 months

Strength testing of grip and pinch

Timeframe: Change from Baseline to 12 months

Disability of the Arm Shoulder Hand DASH

Timeframe: Change from Baseline to 12 months

Trial details

NCT IDNCT03906604

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-27

View on ClinicalTrials.gov More Carpal Tunnel Syndrome Bilateral trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Change from Baseline to 12 months

Visual analog pain scale

Timeframe: Change from Baseline to 12 months

Strength testing of grip and pinch

Timeframe: Change from Baseline to 12 months

Disability of the Arm Shoulder Hand DASH

Timeframe: Change from Baseline to 12 months