Back to resultsBotulinum Toxin for Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Botulinum toxin
Corticosteroid injection into Carpal Tunnel
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
Eligibility 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.
Sites / Locations
- University of Minnesota PM&R Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
2
1
Arm Description
Corticosteroid injection into Carpal Tunnel
Botulinum toxin injection into Carpal Tunnel
Outcomes
Primary Outcome Measures
Visual Analog Scale
Secondary Outcome Measures
Carpal Tunnel Syndrome Assessment Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00701233
Brief Title
Botulinum Toxin for Carpal Tunnel Syndrome
Official Title
Evaluation of Intercarpal Botox Versus Steroid Injections for Carpal Tunnel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to generate MD's and patients for this study
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Description
Corticosteroid injection into Carpal Tunnel
Arm Title
1
Arm Type
Active Comparator
Arm Description
Botulinum toxin injection into Carpal Tunnel
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin
Intervention Description
45 units Botox injected into Carpal Tunnel once
Intervention Type
Drug
Intervention Name(s)
Corticosteroid injection into Carpal Tunnel
Intervention Description
40 mg Triamcinolone with one mL 1% lidocaine injected once into Carpal Tunnel
Primary Outcome Measure Information:
Title
Visual Analog Scale
Time Frame
one week, one month, three months, six month, nine months, and twelve months
Secondary Outcome Measure Information:
Title
Carpal Tunnel Syndrome Assessment Questionnaire
Time Frame
one week, one month, three months, six month, nine months, and twelve months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Dykstra, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota PM&R Department
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
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Botulinum Toxin for Carpal Tunnel Syndrome
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