Lipografting Versus Steroid Injections for Treatment of Carpal Tunnel Syndrome
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|ClinicalTrials.gov Identifier: NCT03722303|
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : October 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Carpal Tunnel Syndrome||Other: Fat Injection Drug: Steroid Injection||Early Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Lipografting Versus Steroid Injections for Treatment of Primary Mild to Moderate Carpal Tunnel Syndrome|
|Actual Study Start Date :||December 19, 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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 Name: 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 Name: Fat Transfer
- 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.
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722303
|Contact: Christina Freibott||(212) firstname.lastname@example.org|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Christina Freibott 212-305-3912 email@example.com|
|Principal Investigator: Melvin P Rosenwasser, MD|
|Principal Investigator:||Melvin P Rosenwasser, MD||Department of Orthopaedic Surgery at Columbia University Medical Center|