Botulinum Toxin for Carpal Tunnel Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00701233
First received: June 17, 2008
Last updated: December 16, 2013
Last verified: December 2013

June 17, 2008
December 16, 2013
June 2012
May 2015   (final data collection date for primary outcome measure)
Visual Analog Scale [ Time Frame: one week, one month, three months, six month, nine months, and twelve months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00701233 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Botulinum Toxin for Carpal Tunnel Syndrome
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Carpal Tunnel Syndrome
  • 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
  • Active Comparator: 2
    Corticosteroid injection into Carpal Tunnel
    Intervention: Drug: Corticosteroid injection into Carpal Tunnel
  • Active Comparator: 1
    Botulinum toxin injection into Carpal Tunnel
    Intervention: Drug: Botulinum toxin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
June 2015
May 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00701233
0708M13705
Yes
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Not Provided
Principal Investigator: Dennis Dykstra, MD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP