TTP-50: A Comparison of Incisionless Ultrasound Guided Thread Carpal Tunnel Release and Mini Open Carpal in Patients With Bilateral Carpal Tunnel Syndrome

• Sponsor: Mayo Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03906604
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.7
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome Bilateral	Procedure: Carpal Tunnel Procedure (open)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Comparison of Incisionless Ultrasound Guided Thread Carpal Tunnel Release and Mini Open Carpal in Patients With Bilateral Carpal Tunnel Syndrome: A Transform the Practice Study
• Actual Study Start Date: Feb 5, 2019
• Actual Primary Completion Date: Jul 27, 2020
• Actual Study Completion Date: Jul 27, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Dominant hand-open Carpal Tunnel Release Standard mini-open carpal tunnel release (standard of care) on the dominant hand.	Procedure: Carpal Tunnel Procedure (open); 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.; Other Names: Carpal Tunnel Procedure (Incisionless)
Other: Dominant hand-Incisionless thread carpal tunnel release Incisionless thread carpal tunnel release on the dominant hand.	Procedure: Carpal Tunnel Procedure (open); 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.; Other Names: Carpal Tunnel Procedure (Incisionless)

Outcome Measures

Primary Outcome Measures

1. Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) functional score [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 [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 and pinch [Change from Baseline to 12 months]

   Use dynameters and pinch meters

4. Disability of the Arm Shoulder Hand DASH [Change from Baseline to 12 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55901

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Alexander Shin, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Review.
• 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. Review.
• 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. Review.
• 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.
• 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.

• Responsible Party: Alexander Y. Shin, M.D., Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03906604
• Other Study ID Numbers: 18-010050
• First Posted: Apr 8, 2019
• Last Update Posted: Apr 6, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carpal Tunnel Syndrome; Syndrome

Study Results

No Results Posted as of Apr 6, 2022