Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome

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