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Difficulty recruiting for open carpal tunnel study arm
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dominant hand-open Carpal Tunnel Release | Other | Standard mini-open carpal tunnel release (standard of care) on the dominant hand. |
|
| Dominant hand-Incisionless thread carpal tunnel release | Other | Incisionless thread carpal tunnel release on the dominant hand. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Shin, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11418908 | Background | 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. | |
| 22727925 | 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. |
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| 20599038 | 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. |
| 20599039 | 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. |
| 27554942 | 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. |
| 25767420 | 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. |
| 28832215 | 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. |
| 25177448 | 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. |
| 15010164 | 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. |
| 25046667 | 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. |