Clinical trial NCT03722303: 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
Overall status: SUSPENDED
Phase: EARLY_PHASE1
Conditions: Carpal Tunnel Syndrome
Keywords: carpal
tunnel
injection
steroid
lipografting
numbness
tingling
median nerve
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Orthopaedic Scientific Research Foundation
First posted: 2018-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Functional Outcome Score
timeFrame: Up to 1 year post-treatment
Secondary outcomes:
measure: Score on the Michigan Hand Questionnaire (MHQ)
timeFrame: Up to 1 year post-treatment
measure: Score on the Brigham Women's Carpal Tunnel Questionnaire
timeFrame: Up to 1 year post-treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Department of Orthopaedic Surgery at Columbia University Medical Center
name: Melvin P Rosenwasser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: LeBlanc KE, Cestia W. Carpal tunnel syndrome. Am Fam Physician. 2011 Apr 15;83(8):952-8.
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.
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.
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.