Conditions: Carpal Tunnel Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 10
Healthy volunteers: no

Brief summary:
This study will be a prospective double blind controlled randomized trial of ten patients diagnosed with Carpal Tunnel Syndrome (CTS). The study will be completed at offices of medical practices in Arizona. Patients who meet inclusion criteria will be randomly distributed into two groups: a BOTOX® (onabotulinumtoxin A) injection group and a Normal Saline Injection (NS) (Placebo group). Each group will consist of five randomly assigned individuals.

Detailed description:
This is a pilot study, to assist with determining appropriate BOTOX® (onabotulinumtoxin A) dosing and injection locations in patients suffering from CTS.

Outcome measures will be obtained at follow-up at 6, 12, and 18 weeks post BOTOX® (onabotulinumtoxin A) injection and post saline injection using the same scales and instruments at baseline, namely Levine scale, JAMAR pinch dynamometer, EDX/NCS and NMUS. These measurements will be used to identify the effectiveness of BOTOX® (onabotulinumtoxin A) in decreasing thenar muscle strength, appropriate BOTOX® (onabotulinumtoxin A) injection dosing, and ability to decrease the inflammation, median nerve dysfunction, edema, symptoms of pain, numbness, and tingling often with associated with CTS.

Arms:
arm 1: After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB) arm 2: .4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)

Interventions: intervention 1: Botulinum Toxin Type A intervention 2: Placebo
Intervention descriptions: intervention 1: 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each intervention 2: Placebo (Normal Saline) divided into 2 injections of .4cc each

Protocol document: