Lipografting Versus Steroid Injections for Treatment of Carpal Tunnel Syndrome

Columbia University

Status and phase: Suspended; Early Phase 1

Conditions: Carpal Tunnel Syndrome

Treatments: Other: Fat Injection; Drug: Steroid Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03722303

AAAK4700

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Steroid Injection

Active Comparator group

Description:

Subjects with CTS will receive steroid injection.

Treatment:

Drug: Steroid Injection

Fat Injection

Experimental group

Description:

Subjects with CTS will receive fat injection.

Treatment:

Other: Fat Injection