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: September 18, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 17, 2008

Last Updated Date

September 18, 2012

Start Date ^ICMJE

June 2012

Estimated Primary Completion Date

May 2013 (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

Complete list of historical versions of study NCT00701233 on ClinicalTrials.gov Archive Site

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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.

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Carpal Tunnel Syndrome

Intervention ^ICMJE

Drug: Botulinum toxin
45 units Botox injected into Carpal Tunnel once
Drug: Corticosteroid injection into Carpal Tunnel
40 mg Triamcinolone with one mL 1% lidocaine injected once into Carpal Tunnel

Study Arm (s)

Active Comparator: 2
Corticosteroid injection into Carpal Tunnel

Intervention: Drug: Corticosteroid injection into Carpal Tunnel
Active Comparator: 1
Botulinum toxin injection into Carpal Tunnel

Intervention: Drug: Botulinum toxin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2014

Estimated Primary Completion Date

May 2013 (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 information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00701233

Other Study ID Numbers ^ICMJE

0708M13705

Has Data Monitoring Committee

Yes

Responsible Party

University of Minnesota - Clinical and Translational Science Institute

Study Sponsor ^ICMJE

University of Minnesota - Clinical and Translational Science Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Dennis Dykstra, MD

University of Minnesota - Clinical and Translational Science Institute

Information Provided By

University of Minnesota - Clinical and Translational Science Institute

Verification Date

September 2012

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

To Top