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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
10
40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each
Placebo (Normal Saline) divided into 2 injections of .4cc each
Arizona Arthritis & Rheumatology
Phoenix, Arizona, United States
Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18.
Patients with Levine score \< 4 were included in the study. The score for this assessment can range from 11-55.
Time frame: Baseline-Week 18
Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18.
Patients with Levine score of \< 4 were included in the study. The score for this assessment can range from 8-40
Time frame: Baseline-Week 18
Change From Baseline in Median Nerve Compression on Neuromuscular Ultrasound at Week 6, Week 12, and Week 18.
Neuromuscular ultrasound measures nerve compression (swelling) by cross sectional area of median nerve, in format % change from baseline.
Time frame: Baseline to Week 18
Change From Baseline Electrodiagnostics Distal Sensory Median Nerve Latency at Week 6, Week 12, and Week 18.
Latency is the interval between the stimulation of a muscle and the observed response, measuring conduction speed in milliseconds compared to baseline
Time frame: Baseline, week 6, week 12, and week 18.
Change From Baseline Electrodiagnostics Motor Median Nerve Latency at Week 6, Week 12, and Week 18.
Latency is the interval between the stimulation of a muscle and the observed response measuring nerve conduction speed in milliseconds.
Time frame: Baseline to Week 18
Change From Baseline Jamar Pinch (Unrelated Dominant Hand - Mean Value of All Repetitions/Positions) at Weeks 6, 12,18.
Mean value of one finger and two finger opposition pinch between 1st and 5th and 1st with 4th and 5th phalanges.
Time frame: Baseline-Week 18
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