Botulinum Toxin for Carpal Tunnel Syndrome

April 15, 2019 updated by: University of Minnesota

Evaluation of Intercarpal Botox Versus Steroid Injections for Carpal Tunnel Syndrome

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Analog Scale
Time Frame: one week, one month, three months, six month, nine months, and twelve months
one week, one month, three months, six month, nine months, and twelve months

Secondary Outcome Measures

Outcome Measure
Time Frame
Carpal Tunnel Syndrome Assessment Questionnaire
Time Frame: one week, one month, three months, six month, nine months, and twelve months
one week, one month, three months, six month, nine months, and twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Dennis Dykstra, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

October 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

June 17, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0708M13705

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carpal Tunnel Syndrome

Clinical Trials on Corticosteroid injection into Carpal Tunnel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe