Lipografting Versus Steroid Injections for Treatment of Carpal Tunnel Syndrome

October 26, 2018 updated by: Melvin Rosenwasser, Columbia University

Lipografting Versus Steroid Injections for Treatment of Primary Mild to Moderate Carpal Tunnel Syndrome

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Contact:
        • Principal Investigator:
          • Melvin P Rosenwasser, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Steroid Injection
Subjects with CTS will receive steroid injection.
Drug: Steroid Injection
Standard of care non-operative treatment for the treatment of Carpal Tunnel Syndrome
Other Names:
  • Cortisone Injection
Experimental: Fat Injection
Subjects with CTS will receive fat injection.
Other: Fat Injection
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.
Other Names:
  • Fat Transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Outcome Score
Time Frame: Up to 1 year post-treatment
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.
Up to 1 year post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score on the Michigan Hand Questionnaire (MHQ)
Time Frame: Up to 1 year post-treatment
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.
Up to 1 year post-treatment
Score on the Brigham Women's Carpal Tunnel Questionnaire
Time Frame: Up to 1 year post-treatment
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).
Up to 1 year post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Orthopaedic Scientific Research Foundation

Investigators

  • Principal Investigator: Melvin P Rosenwasser, MD, Department of Orthopaedic Surgery at Columbia University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

October 25, 2018

First Submitted That Met QC Criteria

October 25, 2018

First Posted (Actual)

October 26, 2018

Study Record Updates

Last Update Posted (Actual)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAK4700

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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