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
| NCT number | NCT04101955 |
| Other study ID # | 18-010569 |
| Secondary ID | |
| Status | Suspended |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 2024 |
| Est. completion date | July 2024 |
| Verified date | October 2023 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic |
United States,
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
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05067205 -
Minimal Invasive Carpal Tunnel Release With the Novel Device
|
N/A | |
| Completed |
NCT03184688 -
Platelet Rich Plasma for Carpal Tunnel Syndrome
|
N/A | |
| Completed |
NCT03582735 -
Preoperative Neuromobilization Exercises for Individuals With Carpal Tunnel Syndrome
|
N/A | |
| Completed |
NCT05490420 -
Effects of Upper Extremity Manual Lymphatic Drainage on Symptom Severity, Hand Functions, Electrophysiological and Ultrasonographic Measurements in Carpal Tunnel Syndrome
|
N/A | |
| Recruiting |
NCT05970692 -
Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale
|
||
| Completed |
NCT04043780 -
Clinical Validation of a Decompression Prototype Splint for Patients With Carpal Tunel Syndrome
|
N/A | |
| Completed |
NCT03880812 -
Cost Information on Carpal Tunnel Syndrome Treatment Decisions
|
N/A | |
| Recruiting |
NCT05328180 -
aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE)
|
N/A | |
| Recruiting |
NCT05503719 -
An Absorbable Suture Versus a Non-absorbable Suture in Carpal Tunnel Release, a Randomized Controlled Trial
|
N/A | |
| Recruiting |
NCT05372393 -
Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block
|
N/A | |
| Recruiting |
NCT05466162 -
Soft Tissue Massage Along With Mobilization Technique on Symptoms and Functional Status of Carpal Tunnel Syndrome
|
N/A | |
| Completed |
NCT04060875 -
Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
|
||
| Not yet recruiting |
NCT06294821 -
4AP to Delay Carpal Tunnel Release (CTR)
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT04328805 -
Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome.
|
Phase 4 | |
| Terminated |
NCT02791529 -
Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release
|
Phase 1 | |
| Completed |
NCT02141035 -
Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome
|
Phase 2/Phase 3 | |
| Completed |
NCT01887145 -
Comparison of Long-term Outcomes Following Endoscopic or Open Surgery for Carpal Tunnel Syndrome
|
N/A | |
| Recruiting |
NCT01897272 -
Post-Operative Splinting After Short-Incision Carpal Tunnel Release: a Prospective Study
|
N/A | |
| Completed |
NCT01394822 -
Neuromuscular Ultrasound for Focal Neuropathies
|
N/A | |
| Enrolling by invitation |
NCT01017471 -
Carpal Tunnel Syndrome Release Using PSU Retractor
|
Phase 3 |