Botulinum Toxin for Carpal Tunnel Syndrome - Full Text View

Sponsor:	University of Minnesota
Information provided by:	University of Minnesota
ClinicalTrials.gov Identifier:	NCT00701233

Purpose

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.

Condition	Intervention
Carpal Tunnel Syndrome	Drug: Botulinum toxin Drug: Corticosteroid injection into Carpal Tunnel

Study Type:	Interventional
Study Design:	Treatment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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 hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Carpal Tunnel Syndrome

Drug Information available for: Clostridium botulinum toxin Corticosteroids

U.S. FDA Resources

Further study details as provided by University of Minnesota:

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 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator Corticosteroid injection into Carpal Tunnel	Drug: Corticosteroid injection into Carpal Tunnel 40 mg Triamcinolone with one mL 1% lidocaine injected once into Carpal Tunnel
1: Active Comparator Botulinum toxin injection into Carpal Tunnel	Drug: Botulinum toxin 45 units Botox injected into Carpal Tunnel once

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: Phillip J Smith, DO

(612) 625-2661

Locations

United States, Minnesota
University of Minnesota PM&R Department
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

More Information

No publications provided

Responsible Party:	University of Minnesota Physical Medicine and Rehabilitation ( Dennis Dykstra, MD, PhD )
Study ID Numbers:	0708M13705, CTSBotox
Study First Received:	June 17, 2008
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00701233 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Median Neuropathy
Carpal Tunnel Syndrome
Disease
Anti-Dyskinesia Agents
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin
Mononeuropathies
Pharmacologic Actions
Nerve Compression Syndromes

Botulinum Toxins
Pathologic Processes
Neuromuscular Diseases
Therapeutic Uses
Syndrome
Peripheral Nervous System Diseases
Central Nervous System Agents
Cumulative Trauma Disorders
Sprains and Strains

ClinicalTrials.gov processed this record on November 05, 2009