Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome
Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome
Interventional study to evaluate efficacy and safety of an active splint.
Inclusion Criteria:

 -  Male or female patients, above 40 years of age.

 -  Able to understand and sign informed consent

 -  Pain associated with mild to moderate carpal tunnel syndrome in a single wrist

 -  Numbness and tingling in the median nerve distribution

 -  Nocturnal Numbness

 -  Weakness and/or atrophy of the thenar musculature

 -  Demonstrate positive Phalen's Test of the affected extremity

 -  Demonstrate positive Tinel's Test of the affected extremity

 -  Sensory impairment defined as a loss of 2-point discrimination

 -  Have recent (within 3 months) electro-diagnostic evidence of Carpal Tunnel Syndrome

 Exclusion Criteria:• Currently receiving treatment for carpal tunnel syndrome

 -  History of surgical carpal tunnel release

 -  Pregnancy

 -  Diabetes not controlled by medication

 -  Radiculopathy i.e., cervical radiculopathy, diabetic radiculopathy

 -  Thoracic outlet syndrome

 -  Compromised skin integrity

 -  Past history of traumatic event, surgery, or congenital impairment of the forearm,
 wrist, or hand