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
  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:


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 2015
Estimated Primary Completion Date: May 2015 (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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: December 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Syndrome
Carpal Tunnel Syndrome
Nerve Compression Syndromes
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
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 September 18, 2014