Ultrasound Guided - Incisionless Threaded Carpal Tunnel Release

Carpal Tunnel Syndrome Clinical Trial

Official title:

Ultrasound Guided - Incisionless Thread Carpal Tunnel Release Versus Standard Mini-Open Carpal Tunnel Release for the Treatment of Carpal Tunnel Syndrome: A Randomized Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04101955
• Other study ID #: 18-010569
• Status: Suspended
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2024

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 142
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Procedure:
• Incisionless Threaded Carpal Tunnel
ultra-minimally invasive thread carpal tunnel release
• Standard Mini-Open Carpal Tunnel
open surgical carpal tunnel release

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Strength testing of grip	Use dynameters	Time Frame: Change from Baseline to 12 months
Primary	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
Primary	Strength testing of pinch	Use pinch meters	Time Frame: Change from Baseline to 12 months

External Links

•   Mayo Clinic Clinical Trials