Botulinum Toxin for Carpal Tunnel Syndrome

Verified by: University of Minnesota - Clinical and Translational Science Institute, November 2010
First Received: June 17, 2008 | Last Updated: February 3, 2012 | Phase: Phase 2 | Start Date: June 2012
Overall Status: Not yet recruiting | Estimated Enrollment: 20
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To compare local steroid injections to local Botulinum toxin A injection in a double-blinded study...

Brief Summary

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

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

  • 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
  • Study Primary Completion Date: May 2013

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

  • Drug: Botulinum toxin
    • 45 units Botox injected into Carpal Tunnel once
  • Drug: Corticosteroid injection into Carpal Tunnel
    • 40 mg Triamcinolone with one mL 1% lidocaine injected once into Carpal Tunnel

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 2
    • Corticosteroid injection into Carpal Tunnel
  • Active Comparator: 1
    • Botulinum toxin injection into Carpal Tunnel

Outcome Measures for this Clinical Trial

Primary Measures

  • Visual Analog Scale
    • Time Frame: one week, one month, three months, six month, nine months, and twelve months
      Safety Issue?: No

Secondary Measures

  • Carpal Tunnel Syndrome Assessment Questionnaire
    • Time Frame: one week, one month, three months, six month, nine months, and twelve months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: University of Minnesota - Clinical and Translational Science Institute Other

Overall Clinical Trial Officials and Contacts

Dennis Dykstra, MD Principal Investigator University of Minnesota - Clinical and Translational Science Institute  

Overall Contact: Dennis Dykstra, MD  dykst001@umn.edu

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00701233

Study ID Number: 0708M13705

ClinicalTrials.gov Identifier: NCT00701233

Health Authority: United States: Food and Drug Administration

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