Botulinum Toxin for Carpal Tunnel Syndrome
This study is ongoing, but not recruiting participants.
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00701233
First received: June 17, 2008
Last updated: September 18, 2012
Last verified: September 2012
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Purpose
To compare local steroid injections to local Botulinum toxin A injection in a double-blinded study.
| Condition | Intervention | Phase |
|---|---|---|
|
Carpal Tunnel Syndrome |
Drug: Botulinum toxin Drug: Corticosteroid injection into Carpal Tunnel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Evaluation of Intercarpal Botox Versus Steroid Injections for Carpal Tunnel Syndrome |
Resource links provided by NLM:
Genetics Home Reference related topics:
Charcot-Marie-Tooth disease
hereditary neuropathy with liability to pressure palsies
U.S. FDA Resources
Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:
Primary Outcome Measures:
- Visual Analog Scale [ Time Frame: one week, one month, three months, six month, nine months, and twelve months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Carpal Tunnel Syndrome Assessment Questionnaire [ Time Frame: one week, one month, three months, six month, nine months, and twelve months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 2
Corticosteroid injection into Carpal Tunnel
|
Drug: Corticosteroid injection into Carpal Tunnel
40 mg Triamcinolone with one mL 1% lidocaine injected once into Carpal Tunnel
|
|
Active Comparator: 1
Botulinum toxin injection into Carpal Tunnel
|
Drug: Botulinum toxin
45 units Botox injected into Carpal Tunnel once
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701233
Locations
| United States, Minnesota | |
| University of Minnesota PM&R Department | |
| Minneapolis, Minnesota, United States, 55455 | |
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
| Principal Investigator: | Dennis Dykstra, MD | University of Minnesota - Clinical and Translational Science Institute |
More Information
No publications provided
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT00701233 History of Changes |
| Other Study ID Numbers: | 0708M13705 |
| Study First Received: | June 17, 2008 |
| Last Updated: | September 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carpal Tunnel Syndrome Median Neuropathy Mononeuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Nerve Compression Syndromes Cumulative Trauma Disorders |
Sprains and Strains Wounds and Injuries Botulinum Toxins Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013