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Botulinum Toxin for Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT00701233
Recruitment Status : Active, not recruiting
First Posted : June 19, 2008
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Drug: Botulinum toxin Drug: Corticosteroid injection into Carpal Tunnel Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Intercarpal Botox Versus Steroid Injections for Carpal Tunnel Syndrome
Study Start Date : June 2012
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: one week, one month, three months, six month, nine months, and twelve months ]

Secondary Outcome Measures :
  1. Carpal Tunnel Syndrome Assessment Questionnaire [ Time Frame: one week, one month, three months, six month, nine months, and twelve months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00701233     History of Changes
Other Study ID Numbers: 0708M13705
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017

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
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs