Ultrasound Guided - Incisionless Threaded Carpal Tunnel Release

NCT ID: NCT04101955

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2025-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Incisionless Threaded Carpal Tunnel

Group Type OTHER

Incisionless Threaded Carpal Tunnel

Intervention Type PROCEDURE

ultra-minimally invasive thread carpal tunnel release

Standard Mini-Open Carpal Tunnel

Intervention Type PROCEDURE

open surgical carpal tunnel release

Standard Mini-Open Carpal Tunnel

Group Type OTHER

Incisionless Threaded Carpal Tunnel

Intervention Type PROCEDURE

ultra-minimally invasive thread carpal tunnel release

Standard Mini-Open Carpal Tunnel

Intervention Type PROCEDURE

open surgical carpal tunnel release

Interventions

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Incisionless Threaded Carpal Tunnel

ultra-minimally invasive thread carpal tunnel release

Intervention Type PROCEDURE

Standard Mini-Open Carpal Tunnel

open surgical carpal tunnel release

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Alexander Y. Shin, M.D.

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander Shin, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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Papanicolaou GD, McCabe SJ, Firrell J. The prevalence and characteristics of nerve compression symptoms in the general population. J Hand Surg Am. 2001 May;26(3):460-6. doi: 10.1053/jhsu.2001.24972.

Reference Type BACKGROUND
PMID: 11418908 (View on PubMed)

Harry S, Tanya R. Carpal tunnel claims rank second among major lost time diagnosis. NCCI Research Brief 2005 Apr; Vol.3

Reference Type BACKGROUND

Fajardo M, Kim SH, Szabo RM. Incidence of carpal tunnel release: trends and implications within the United States ambulatory care setting. J Hand Surg Am. 2012 Aug;37(8):1599-605. doi: 10.1016/j.jhsa.2012.04.035. Epub 2012 Jun 23.

Reference Type BACKGROUND
PMID: 22727925 (View on PubMed)

Huisstede BM, Hoogvliet P, Randsdorp MS, Glerum S, van Middelkoop M, Koes BW. Carpal tunnel syndrome. Part I: effectiveness of nonsurgical treatments--a systematic review. Arch Phys Med Rehabil. 2010 Jul;91(7):981-1004. doi: 10.1016/j.apmr.2010.03.022.

Reference Type BACKGROUND
PMID: 20599038 (View on PubMed)

Huisstede BM, Randsdorp MS, Coert JH, Glerum S, van Middelkoop M, Koes BW. Carpal tunnel syndrome. Part II: effectiveness of surgical treatments--a systematic review. Arch Phys Med Rehabil. 2010 Jul;91(7):1005-24. doi: 10.1016/j.apmr.2010.03.023.

Reference Type BACKGROUND
PMID: 20599039 (View on PubMed)

Guo D, Guo D, Guo J, Malone DG, Wei N, McCool LC. A Cadaveric Study for the Improvement of Thread Carpal Tunnel Release. J Hand Surg Am. 2016 Oct;41(10):e351-e357. doi: 10.1016/j.jhsa.2016.07.098. Epub 2016 Aug 20.

Reference Type BACKGROUND
PMID: 27554942 (View on PubMed)

Guo D, Guo D, Guo J, Schmidt SC, Lytie RM. A Clinical Study of the Modified Thread Carpal Tunnel Release. Hand (N Y). 2017 Sep;12(5):453-460. doi: 10.1177/1558944716668831. Epub 2016 Sep 12.

Reference Type BACKGROUND
PMID: 28832215 (View on PubMed)

Guo D, Tang Y, Ji Y, Sun T, Guo J, Guo D. A non-scalpel technique for minimally invasive surgery: percutaneously looped thread transection of the transverse carpal ligament. Hand (N Y). 2015 Mar;10(1):40-8. doi: 10.1007/s11552-014-9656-4.

Reference Type BACKGROUND
PMID: 25767420 (View on PubMed)

Kim PT, Lee HJ, Kim TG, Jeon IH. Current approaches for carpal tunnel syndrome. Clin Orthop Surg. 2014 Sep;6(3):253-7. doi: 10.4055/cios.2014.6.3.253. Epub 2014 Aug 5.

Reference Type BACKGROUND
PMID: 25177448 (View on PubMed)

Greenslade JR, Mehta RL, Belward P, Warwick DJ. Dash and Boston questionnaire assessment of carpal tunnel syndrome outcome: what is the responsiveness of an outcome questionnaire? J Hand Surg Br. 2004 Apr;29(2):159-64. doi: 10.1016/j.jhsb.2003.10.010.

Reference Type BACKGROUND
PMID: 15010164 (View on PubMed)

Related Links

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Other Identifiers

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18-010569

Identifier Type: -

Identifier Source: org_study_id

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