Lipografting Versus Steroid Injections for Treatment of Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03722303
• Other study ID #: AAAK4700
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 19, 2016
• Est. completion date: December 2019

Study information

• Verified date: October 2018
• Source: Columbia University
• Contact: Christina Freibott
• Phone: (212) 305-3912
• Email: cef2141[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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.

Drug:
• Steroid Injection
Standard of care non-operative treatment for the treatment of Carpal Tunnel Syndrome

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Orthopaedic Scientific Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

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):272-80. doi: 10.1097/PRS.0b013e3181a09506. — View 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. — View Citation

LeBlanc KE, Cestia W. Carpal tunnel syndrome. Am Fam Physician. 2011 Apr 15;83(8):952-8. — View Citation

Marshall S, Tardif G, Ashworth N. Local corticosteroid injection for carpal tunnel syndrome. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD001554. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 1 year post-treatment
Secondary	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.	Up to 1 year post-treatment
Secondary	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).	Up to 1 year post-treatment