Ultrasound Guided - Incisionless Threaded Carpal Tunnel Release

NCT04101955 | Completed DMC

• 1 other identifier: 18-010569
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (5)

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

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

  Time Frame: Change from Baseline to 12 months

• Visual analog pain scale

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

  Time Frame: Change from Baseline to 12 months

• Strength testing of grip

  Use dynameters

  Time Frame: Change from Baseline to 12 months

• Disability of the Arm Shoulder Hand DASH

  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.

  Time Frame: Change from Baseline to 12 months

• Strength testing of pinch

  Use pinch meters

  Time Frame: Change from Baseline to 12 months

Study Arms (2)

Incisionless Threaded Carpal Tunnel

OTHER

Procedure: Incisionless Threaded Carpal Tunnel; Procedure: Standard Mini-Open Carpal Tunnel

Standard Mini-Open Carpal Tunnel

OTHER

Procedure: Incisionless Threaded Carpal Tunnel; Procedure: Standard Mini-Open Carpal Tunnel

Interventions

Incisionless Threaded Carpal Tunnel PROCEDURE

ultra-minimally invasive thread carpal tunnel release

Incisionless Threaded Carpal Tunnel; Standard Mini-Open Carpal Tunnel

Standard Mini-Open Carpal Tunnel PROCEDURE

open surgical carpal tunnel release

Incisionless Threaded Carpal Tunnel; Standard Mini-Open Carpal Tunnel

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

Related Publications (10)

• 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.

  PMID: 11418908 BACKGROUND

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

  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.

  PMID: 22727925 BACKGROUND

• 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.

  PMID: 20599038 BACKGROUND

• 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.

  PMID: 20599039 BACKGROUND

• 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.

  PMID: 27554942 BACKGROUND

• 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.

  PMID: 28832215 BACKGROUND

• 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.

  PMID: 25767420 BACKGROUND

• 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.

  PMID: 25177448 BACKGROUND

• 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.

  PMID: 15010164 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

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

• Alexander Shin, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 24, 2019
• Study Start: July 1, 2020
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)