Botulinum Toxin for Carpal Tunnel Syndrome - Tabular View

Tracking Information

First Received Date ^ICMJE

June 17, 2008

Last Updated Date

June 17, 2008

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Visual Analog Scale [ Time Frame: one week, one month, three months, six month, nine months, and twelve months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Botulinum Toxin for Carpal Tunnel Syndrome

Official Title ^ICMJE

Evaluation of Intercarpal Botox Versus Steroid Injections for Carpal Tunnel Syndrome

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Carpal Tunnel Syndrome

Intervention ^ICMJE

Drug: Botulinum toxin
Drug: Corticosteroid injection into Carpal Tunnel

Study Arms / Comparison Groups

Active Comparator: Corticosteroid injection into Carpal Tunnel
Active Comparator: Botulinum toxin injection into Carpal Tunnel

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Phillip J Smith, DO

(612) 625-2661

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00701233

Responsible Party

Dennis Dykstra, MD, PhD, University of Minnesota Physical Medicine and Rehabilitation

Study ID Numbers ^ICMJE

0708M13705, CTSBotox

Study Sponsor ^ICMJE

University of Minnesota

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

University of Minnesota

Verification Date

June 2008

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