Botulinum Toxin for Carpal Tunnel Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2018-10-31

Brief Summary

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

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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.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2

Corticosteroid injection into Carpal Tunnel

Group Type ACTIVE_COMPARATOR

Corticosteroid injection into Carpal Tunnel

Intervention Type DRUG

40 mg Triamcinolone with one mL 1% lidocaine injected once into Carpal Tunnel

1

Botulinum toxin injection into Carpal Tunnel

Group Type ACTIVE_COMPARATOR

Botulinum toxin

Intervention Type DRUG

45 units Botox injected into Carpal Tunnel once

Interventions

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Botulinum toxin

45 units Botox injected into Carpal Tunnel once

Intervention Type DRUG

Corticosteroid injection into Carpal Tunnel

40 mg Triamcinolone with one mL 1% lidocaine injected once into Carpal Tunnel

Intervention Type DRUG

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

1. Any individual who has a diagnosis of CTS (by EMG or other means) but no symptoms of CTS will be excluded from this study.
2. Vulnerable subjects as defined as children, pregnant women, those with limited autonomy, decisional incapacity and prisoners will not be enrolled in this study.
3. Individuals with any history of carpal tunnel release surgery and recurrent or persistent symptoms will be excluded form this study.
4. Subject is pregnant or lactating.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No