BOTOX® (Onabotulinumtoxin A) Injection(s) as a Treatment for Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Intervention: Botulinum Toxin Type A; Placebo
Intervention description: 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
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient history: evaluated using the Levine Scale for CTS, a self-administered
             questionnaire which assesses the function and severity of CTS.

          -  Physical Exam: including use of JAMAR pinch dynamometer to quantify initial baseline
             strength and confirm decreased pinch strength post injection to verify effective
             BOTOX® (onabotulinumtoxin A) injection.

          -  Electrodiagnostics (EDX): The following criteria would establish CTS through EDX
             namely baseline electromyogram (EMG) and nerve conduction studies (NCS): a) median
             nerve distal motor latency (DML) >4.3ms or >0.9ms above the ulnar nerve DML b) median
             distal sensory latency (DSL) to D-1 >2.9ms or >0.4ms above radial nerve D-1 DSL. c)
             median D-2 DSL >3.7ms or >0.4ms above ulnar nerve D-5 DSL (5). d) median mixed nerve
             palm-to-wrist latency (at 8cm) >2.2ms or >.3ms above ulnar mixed nerve palm-to-wrist
             latency (at 8cm).

          -  Imaging & Measurements (NMUS): Carpal tunnel images will be obtained in a transverse
             plane in both a neutral relaxed position at the level of the pisiform and
             longitudinally during neutral and Dynamic Stress Testing (DST) by a A Sonosite M-Turbo
             6-13 MHz ultrasound system or another similar system (+ 2% accuracy). Measurements:
             Transverse images of the CT will measure the median nerve cross sectional area (CSA)
             at the level of the pisiform bone. CSA measurements greater than 11 mm2 are indicative
             of CTS. Borderline CSA measurements would require wrist forearm ratio (WFR)
             measurements to be a WFR > 1.5. Patients will need to have a CSA >11mm2, (or WFR >1.5)
             and show median nerve compression during DST of at least 30% to be included.

        Exclusion Criteria:

          -  Patients with prior carpal tunnel surgery, prior history of BOTOX® (onabotulinumtoxin
             A) injection

          -  Steroid injection two months prior or three months after BOTOX® (onabotulinumtoxin A)
             CTS injection, median nerve denervation on needle EMG

          -  Major limb trauma or surgery, dysphagia

          -  Neuromuscular junction disorder (ie: Myasthenia gravis or Lambert-Eaton syndrome)

          -  Currently pregnant or breast feeding

          -  Patients with severe CTS identified by Levine scale >4, electrodiagnostics, and/or
             unable to meet the inclusion criteria as identified above would be excluded as
             participants in this study.