Carpal Tunnel Syndrome
Conditions
Brief summary
To compare local steroid injections to local Botulinum toxin A injection in a double-blinded study.
Detailed 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.
Interventions
DRUGBotulinum toxin
45 units Botox injected into Carpal Tunnel once
DRUGCorticosteroid injection into Carpal Tunnel
40 mg Triamcinolone with one mL 1% lidocaine injected once into Carpal Tunnel
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analog Scale | one week, one month, three months, six month, nine months, and twelve months |
Secondary
| Measure | Time frame |
|---|---|
| Carpal Tunnel Syndrome Assessment Questionnaire | one week, one month, three months, six month, nine months, and twelve months |
Countries
United States
Outcome results
None listed