Botulinum Toxin for Carpal Tunnel Syndrome

Study Overview
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Brief Summary
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To compare local steroid injections to local Botulinum toxin A injection in a double-blinded study.

Detailed Description
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To compare local steroid injections to local Botulinum toxin A injection in a double-blinded study. The goal is to investigate if Botulinum toxin A injections are effective for Carpal Tunnel Syndrome compared to steroid injections in terms of pain relief and length of symptom alleviation.

Official Title
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Evaluation of Intercarpal Botox Versus Steroid Injections for Carpal Tunnel Syndrome

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Drug: Botulinum toxin
* Drug: Corticosteroid injection into Carpal Tunnel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any individual with symptoms of carpal tunnel syndrome and a diagnosis of CTS either clinically or via EMG will be included into this study. There will be a total of 20 subjects displaying symptoms of CTS. The gender of the subjects will not determine enrollment. There is no requirement of male to female ratio for this study. There is no age cut-off or minimal age requirement to enroll in the study. No specific Racial or ethnic restrictions will be present for this study. Female subjects of childbearing potential (not surgically sterile or postmenopausal for at least 2 years) must have a negative pregnancy test at screening. Exclusion Criteria: Any individual who has a diagnosis of CTS (by EMG or other means) but no symptoms of CTS will be excluded from this study. Vulnerable subjects as defined as children, pregnant women, those with limited autonomy, decisional incapacity and prisoners will not be enrolled in this study. Individuals with any history of carpal tunnel release surgery and recurrent or persistent symptoms will be excluded form this study. Subject is pregnant or lactating.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Corticosteroid injection into Carpal Tunnel | Drug: Corticosteroid injection into Carpal Tunnel<br>* 40 mg Triamcinolone with one mL 1% lidocaine injected once into Carpal Tunnel<br>|
| Active Comparator: 1<br>Botulinum toxin injection into Carpal Tunnel | Drug: Botulinum toxin<br>* 45 units Botox injected into Carpal Tunnel once<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale |  | one week, one month, three months, six month, nine months, and twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carpal Tunnel Syndrome Assessment Questionnaire |  | one week, one month, three months, six month, nine months, and twelve months |