Lipografting Versus Steroid Injections for Treatment of Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fat Injection
Steroid Injection
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring carpal, tunnel, injection, steroid, lipografting, numbness, tingling, median nerve
Eligibility Criteria
Inclusion Criteria:
- primary mild to moderate carpal tunnel syndrome (CTS)
- report symptoms longer than 6 months
- night pain
- weakness
- sensory deficits
- fluent English-speaking adult (>18)
Exclusion Criteria:
- <18 years old
- Non-english speaking
- injection in past 6 months
- previous hand surgery
- previous hand trauma (fracture or dislocation)
Sites / Locations
- Columbia University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Steroid Injection
Fat Injection
Arm Description
Subjects with CTS will receive steroid injection.
Subjects with CTS will receive fat injection.
Outcomes
Primary Outcome Measures
Functional Outcome Score
This score will be determined by Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH), which is a validated tool/survey for measuring upper extremity disability. The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (4 items, scored 1-5). These raw scores are used to calculate a score out of 100, with a higher score indicating greater disability.
Secondary Outcome Measures
Score on the Michigan Hand Questionnaire (MHQ)
The MHQ is hand-specific outcomes instrument that measures outcomes of patients with conditions of, or injury to, the hand or wrist. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance.
Score on the Brigham Women's Carpal Tunnel Questionnaire
Brigham Women's Carpal Tunnel Questionnaire is a validated tool for measuring severity of symptoms for carpal tunnel syndrome. The questionnaire is self-administered, with each item scored from 1 to 5 (where 1 indicates no symptoms or no functional difficulty, and 5 indicates maximum symptoms or an inability to perform the functional task).
Full Information
NCT ID
NCT03722303
First Posted
October 25, 2018
Last Updated
October 26, 2018
Sponsor
Columbia University
Collaborators
Orthopaedic Scientific Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03722303
Brief Title
Lipografting Versus Steroid Injections for Treatment of Carpal Tunnel Syndrome
Official Title
Lipografting Versus Steroid Injections for Treatment of Primary Mild to Moderate Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 19, 2016 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Orthopaedic Scientific Research Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care, corticosteroid treatment. The investigators hypothesize the fat transfer would prevent scar formation and aid in nerve excursion along the canal (while the neoangiogenic and regenerative growth factors could stimulate nerve regeneration) better than the standard of care treatment.
Detailed Description
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy affecting up to 13% of Americans; CTS is caused by compression of the median nerve in the carpal tunnel leading to nerve ischemia and symptoms of numbness, pain, and tingling. Treatment options depend on the severity of symptoms and range from noninvasive options (most commonly, steroid injections) to definitive surgical release of the compressed median nerve. Both non-invasive techniques and surgical intervention have their shortcomings; thus a novel approach for CTS treatment may be indicated.
Lipografting is an established, validated, and widely used technique of plastic surgeons that injects autologous fat to correct contour deformities. From observing these reconstructions, plastic surgeons have witnessed the regenerative properties of fat transfer, specifically delaying the affects of chronic radio-dermatitis. These clinical manifestations have fostered numerous studies defining fat as a rich source of pluripotent stem cells with the potential for reducing scar formation, bringing neo-angiogenesis, and providing a barrier against scar adhesions This study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care, corticosteroid treatment. Ideally, the fat transfer would prevent scar formation and aid in nerve excursion along the canal, while the neoangiogenic and regenerative growth factors could stimulate nerve regeneration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
carpal, tunnel, injection, steroid, lipografting, numbness, tingling, median nerve
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Steroid Injection
Arm Type
Active Comparator
Arm Description
Subjects with CTS will receive steroid injection.
Arm Title
Fat Injection
Arm Type
Experimental
Arm Description
Subjects with CTS will receive fat injection.
Intervention Type
Other
Intervention Name(s)
Fat Injection
Other Intervention Name(s)
Fat Transfer
Intervention Description
Used by plastic surgeons, lipografting injects autologous fat to correct contour deformities. Plastic surgeons have witnessed the regenerative properties of fat transfer, and these clinical manifestations have fostered numerous studies defining fat as a rich source of pluripotent stem cells with the potential for reducing scar formation, bringing neo-angiogenesis, and providing a barrier against scar adhesions. This study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care, corticosteroid treatment. Ideally, fat transfer would prevent scar formation and aid in nerve excursion along the canal, while the neoangiogenic and regenerative growth factors stimulate nerve regeneration.
Intervention Type
Drug
Intervention Name(s)
Steroid Injection
Other Intervention Name(s)
Cortisone Injection
Intervention Description
Standard of care non-operative treatment for the treatment of Carpal Tunnel Syndrome
Primary Outcome Measure Information:
Title
Functional Outcome Score
Description
This score will be determined by Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH), which is a validated tool/survey for measuring upper extremity disability. The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (4 items, scored 1-5). These raw scores are used to calculate a score out of 100, with a higher score indicating greater disability.
Time Frame
Up to 1 year post-treatment
Secondary Outcome Measure Information:
Title
Score on the Michigan Hand Questionnaire (MHQ)
Description
The MHQ is hand-specific outcomes instrument that measures outcomes of patients with conditions of, or injury to, the hand or wrist. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance.
Time Frame
Up to 1 year post-treatment
Title
Score on the Brigham Women's Carpal Tunnel Questionnaire
Description
Brigham Women's Carpal Tunnel Questionnaire is a validated tool for measuring severity of symptoms for carpal tunnel syndrome. The questionnaire is self-administered, with each item scored from 1 to 5 (where 1 indicates no symptoms or no functional difficulty, and 5 indicates maximum symptoms or an inability to perform the functional task).
Time Frame
Up to 1 year post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
primary mild to moderate carpal tunnel syndrome (CTS)
report symptoms longer than 6 months
night pain
weakness
sensory deficits
fluent English-speaking adult (>18)
Exclusion Criteria:
<18 years old
Non-english speaking
injection in past 6 months
previous hand surgery
previous hand trauma (fracture or dislocation)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Freibott
Phone
(212) 305-3912
Email
cef2141@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melvin P Rosenwasser, MD
Organizational Affiliation
Department of Orthopaedic Surgery at Columbia University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Freibott
Phone
212-305-3912
Email
cef2141@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Melvin P Rosenwasser, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21524035
Citation
LeBlanc KE, Cestia W. Carpal tunnel syndrome. Am Fam Physician. 2011 Apr 15;83(8):952-8.
Results Reference
background
PubMed Identifier
17443508
Citation
Marshall S, Tardif G, Ashworth N. Local corticosteroid injection for carpal tunnel syndrome. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD001554. doi: 10.1002/14651858.CD001554.pub2.
Results Reference
background
PubMed Identifier
19346997
Citation
Gutowski KA; ASPS Fat Graft Task Force. Current applications and safety of autologous fat grafts: a report of the ASPS fat graft task force. Plast Reconstr Surg. 2009 Jul;124(1):272-280. doi: 10.1097/PRS.0b013e3181a09506.
Results Reference
background
PubMed Identifier
22470412
Citation
Ibrahim I, Khan WS, Goddard N, Smitham P. Carpal tunnel syndrome: a review of the recent literature. Open Orthop J. 2012;6:69-76. doi: 10.2174/1874325001206010069. Epub 2012 Feb 23.
Results Reference
background
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Lipografting Versus Steroid Injections for Treatment of Carpal Tunnel Syndrome
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