Overview

This trial is active, not recruiting.

Condition carpal tunnel syndrome
Treatments botulinum toxin, corticosteroid injection into carpal tunnel
Phase phase 2
Sponsor University of Minnesota - Clinical and Translational Science Institute
Start date June 2012
End date May 2017
Trial size 20 participants
Trial identifier NCT00701233, 0708M13705

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Corticosteroid injection into Carpal Tunnel
corticosteroid injection into carpal tunnel
40 mg Triamcinolone with one mL 1% lidocaine injected once into Carpal Tunnel
(Active Comparator)
Botulinum toxin injection into Carpal Tunnel
botulinum toxin
45 units Botox injected into Carpal Tunnel once

Primary Outcomes

Measure
Visual Analog Scale
time frame: one week, one month, three months, six month, nine months, and twelve months

Secondary Outcomes

Measure
Carpal Tunnel Syndrome Assessment Questionnaire
time frame: one week, one month, three months, six month, nine months, and twelve months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Evaluation of Intercarpal Botox Versus Steroid Injections for Carpal Tunnel Syndrome
Principal investigator Dennis Dykstra, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of Minnesota - Clinical and Translational Science Institute.