BOTOX® (Onabotulinumtoxin A) Injection(s) as a Treatment for Carpal Tunnel Syndrome
NCT ID: NCT02070302
Last Updated: 2017-09-27
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2014-10-31
2016-02-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Botulinum Toxin Type A
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)
Botulinum Toxin Type A
40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each
Placebo
.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)
Placebo
Placebo (Normal Saline) divided into 2 injections of .4cc each
Interventions
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Botulinum Toxin Type A
40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each
Placebo
Placebo (Normal Saline) divided into 2 injections of .4cc each
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Benjamin Sucher
OTHER
Responsible Party
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Benjamin Sucher
Principal Investigator
Principal Investigators
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Benjamin Sucher, DO
Role: PRINCIPAL_INVESTIGATOR
Arizona Arthritis & Rheumatology Research
Locations
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Arizona Arthritis & Rheumatology
Phoenix, Arizona, United States
Countries
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Other Identifiers
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85700
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
85700
Identifier Type: -
Identifier Source: org_study_id