Ultrasound Guided - Incisionless Threaded Carpal Tunnel Release
NCT ID: NCT04101955
Last Updated: 2025-08-22
Study Results
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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COMPLETED
NA
12 participants
INTERVENTIONAL
2020-07-01
2025-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Incisionless Threaded Carpal Tunnel
Incisionless Threaded Carpal Tunnel
ultra-minimally invasive thread carpal tunnel release
Standard Mini-Open Carpal Tunnel
open surgical carpal tunnel release
Standard Mini-Open Carpal Tunnel
Incisionless Threaded Carpal Tunnel
ultra-minimally invasive thread carpal tunnel release
Standard Mini-Open Carpal Tunnel
open surgical carpal tunnel release
Interventions
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Incisionless Threaded Carpal Tunnel
ultra-minimally invasive thread carpal tunnel release
Standard Mini-Open Carpal Tunnel
open surgical carpal tunnel release
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Alexander Y. Shin, M.D.
M.D.
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
Countries
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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.
Harry S, Tanya R. Carpal tunnel claims rank second among major lost time diagnosis. NCCI Research Brief 2005 Apr; Vol.3
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.
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.
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.
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.
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.
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.
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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18-010569
Identifier Type: -
Identifier Source: org_study_id
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