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A Comparison of Incisionless Ultrasound Guided Thread Carpal Tunnel Release and Mini Open Carpal in Patients With Bilateral Carpal Tunnel Syndrome (TTP-50)

Primary Purpose

Carpal Tunnel Syndrome Bilateral

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carpal Tunnel Procedure (open)
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome Bilateral

Eligibility Criteria

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

Inclusion Criteria:

  • A diagnosis of bilateral CTS with symptoms including pain, paresthesia's, and weakness of the hand in the median nerve distribution for minimum of 3 months
  • Willingness to undergo bilateral carpal tunnel surgical treatment with one side having the TCTR and the other a mini open carpal tunnel release
  • Age 18-65 years of age
  • Clinical examination findings (compression test, Tinels, Phalens, etc) consistent with carpal tunnel syndrome.
  • 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
  • Able and willing to complete all follow-up appointments

Exclusion Criteria:

  • Previous CTS surgical release on any of their hands
  • Diabetes mellitus
  • Hypothyroidism
  • Significant Hand arthritis (rheumatologic or osteoarthritis)
  • Pregnancy
  • Electromyographic evidence of any condition other than CTS affecting the hand
  • Workman's compensation

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Dominant hand-open Carpal Tunnel Release

Dominant hand-Incisionless thread carpal tunnel release

Arm Description

Standard mini-open carpal tunnel release (standard of care) on the dominant hand.

Incisionless thread carpal tunnel release on the dominant hand.

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 and pinch
Use dynameters and pinch meters
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.

Secondary Outcome Measures

Full Information

First Posted
April 1, 2019
Last Updated
April 4, 2022
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03906604
Brief Title
A Comparison of Incisionless Ultrasound Guided Thread Carpal Tunnel Release and Mini Open Carpal in Patients With Bilateral Carpal Tunnel Syndrome
Acronym
TTP-50
Official Title
A Prospective Comparison of Incisionless Ultrasound Guided Thread Carpal Tunnel Release and Mini Open Carpal in Patients With Bilateral Carpal Tunnel Syndrome: A Transform the Practice Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Difficulty recruiting for open carpal tunnel study arm
Study Start Date
February 5, 2019 (Actual)
Primary Completion Date
July 27, 2020 (Actual)
Study Completion Date
July 27, 2020 (Actual)

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
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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Dominant hand-open Carpal Tunnel Release
Arm Type
Other
Arm Description
Standard mini-open carpal tunnel release (standard of care) on the dominant hand.
Arm Title
Dominant hand-Incisionless thread carpal tunnel release
Arm Type
Other
Arm Description
Incisionless thread carpal tunnel release on the dominant hand.
Intervention Type
Procedure
Intervention Name(s)
Carpal Tunnel Procedure (open)
Other Intervention Name(s)
Carpal Tunnel Procedure (Incisionless)
Intervention Description
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.
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
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
Change from Baseline to 12 months
Title
Strength testing of grip and pinch
Description
Use dynameters and pinch meters
Time Frame
Change from Baseline to 12 months
Title
Disability of the Arm Shoulder Hand DASH
Description
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.
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 bilateral CTS with symptoms including pain, paresthesia's, and weakness of the hand in the median nerve distribution for minimum of 3 months Willingness to undergo bilateral carpal tunnel surgical treatment with one side having the TCTR and the other a mini open carpal tunnel release Age 18-65 years of age Clinical examination findings (compression test, Tinels, Phalens, etc) consistent with carpal tunnel syndrome. 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 Able and willing to complete all follow-up appointments Exclusion Criteria: Previous CTS surgical release on any of their hands Diabetes mellitus Hypothyroidism Significant Hand arthritis (rheumatologic or osteoarthritis) Pregnancy Electromyographic evidence of any condition other than CTS affecting the hand Workman's compensation
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
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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
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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
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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
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Citation
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Results Reference
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PubMed Identifier
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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
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PubMed Identifier
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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
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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.
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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.
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Results Reference
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A Comparison of Incisionless Ultrasound Guided Thread Carpal Tunnel Release and Mini Open Carpal in Patients With Bilateral Carpal Tunnel Syndrome

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