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

NCT03906604 | Terminated DMC

• 1 other identifier: 18-010050
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel Syndrome Bilateral

Outcome Measures

Primary Outcomes (4)

• 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

  Change from Baseline to 12 months

• Visual analog pain scale

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

  Change from Baseline to 12 months

• Strength testing of grip and pinch

  Use dynameters and pinch meters

  Change from Baseline to 12 months

• Disability of the Arm Shoulder Hand DASH

  he 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.

  Change from Baseline to 12 months

Study Arms (2)

Dominant hand-open Carpal Tunnel Release

OTHER

Standard mini-open carpal tunnel release (standard of care) on the dominant hand.

Procedure: Carpal Tunnel Procedure (open)

Dominant hand-Incisionless thread carpal tunnel release

OTHER

Incisionless thread carpal tunnel release on the dominant hand.

Procedure: Carpal Tunnel Procedure (open)

Interventions

Carpal Tunnel Procedure (open) PROCEDURE

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.

Also known as: Carpal Tunnel Procedure (Incisionless)

Dominant hand-Incisionless thread carpal tunnel release; Dominant hand-open Carpal Tunnel Release

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 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

You may not qualify if:

• 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

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

• 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, 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

• 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

• 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

• Michelotti B, Romanowsky D, Hauck RM. Prospective, randomized evaluation of endoscopic versus open carpal tunnel release in bilateral carpal tunnel syndrome: an interim analysis. Ann Plast Surg. 2014 Dec;73 Suppl 2:S157-60. doi: 10.1097/SAP.0000000000000203.

  PMID: 25046667 BACKGROUND

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: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 8, 2019
• Study Start: February 5, 2019
• Primary Completion: July 27, 2020
• Study Completion: July 27, 2020
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)