Botulinum Toxin for Carpal Tunnel Syndrome

This study is not yet open for participant recruitment.

Verified November 2010 by University of Minnesota - Clinical and Translational Science Institute

First Received on June 17, 2008. Last Updated on February 3, 2012 History of Changes

Sponsor:	University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):	Dennis D. Dykstra, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT00701233

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

MedlinePlus related topics: Botox Carpal Tunnel Syndrome

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

Contacts

Contact: Dennis Dykstra, MD

dykst001@umn.edu

Locations

United States, Minnesota
University of Minnesota PM&R Department	Recruiting
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:	Dennis D. Dykstra, MD, 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:	February 3, 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 23, 2012