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Ultrasound Guided - Incisionless Threaded Carpal Tunnel Release

Primary Purpose

Carpal Tunnel Syndrome

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incisionless Threaded Carpal Tunnel
Standard Mini-Open Carpal Tunnel
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Incisionless Threaded Carpal Tunnel

Standard Mini-Open Carpal Tunnel

Arm Description

Outcomes

Primary Outcome Measures

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
Visual analog pain scale
Pain that participant is currently experiencing the in the hand or risk(0-100)
Strength testing of grip
Use dynameters
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.
Strength testing of pinch
Use pinch meters

Secondary Outcome Measures

Full Information

First Posted
September 18, 2019
Last Updated
October 20, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04101955
Brief Title
Ultrasound Guided - Incisionless Threaded Carpal Tunnel Release
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Suspended
Why Stopped
Study paused while working on logistics
Study Start Date
July 2024 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Incisionless Threaded Carpal Tunnel
Arm Type
Other
Arm Title
Standard Mini-Open Carpal Tunnel
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Incisionless Threaded Carpal Tunnel
Intervention Description
ultra-minimally invasive thread carpal tunnel release
Intervention Type
Procedure
Intervention Name(s)
Standard Mini-Open Carpal Tunnel
Intervention Description
open surgical carpal tunnel release
Primary Outcome Measure Information:
Title
Change in Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) functional score
Description
Measured on a symptom severity scale from 1 to 5, where 1 is normal and 5 is very serious/continued/difficult
Time Frame
Time Frame: Change from Baseline to 12 months
Title
Visual analog pain scale
Description
Pain that participant is currently experiencing the in the hand or risk(0-100)
Time Frame
Time Frame: Change from Baseline to 12 months
Title
Strength testing of grip
Description
Use dynameters
Time Frame
Time Frame: Change from Baseline to 12 months
Title
Disability of the Arm Shoulder Hand DASH
Description
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
Time Frame: Change from Baseline to 12 months
Title
Strength testing of pinch
Description
Use pinch meters
Time Frame
Time Frame: Change from Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Shin, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55901
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11418908
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.
Results Reference
background
Citation
Harry S, Tanya R. Carpal tunnel claims rank second among major lost time diagnosis. NCCI Research Brief 2005 Apr; Vol.3
Results Reference
background
PubMed Identifier
22727925
Citation
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.
Results Reference
background
PubMed Identifier
20599038
Citation
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.
Results Reference
background
PubMed Identifier
20599039
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.
Results Reference
background
PubMed Identifier
27554942
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.
Results Reference
background
PubMed Identifier
28832215
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.
Results Reference
background
PubMed Identifier
25767420
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.
Results Reference
background
PubMed Identifier
25177448
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.
Results Reference
background
PubMed Identifier
15010164
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.
Results Reference
background
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Ultrasound Guided - Incisionless Threaded Carpal Tunnel Release

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