Botulinum Toxin for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Evaluation of Intercarpal Botox Versus Steroid Injections for Carpal Tunnel Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00701233
• Other study ID #: 0708M13705
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 2012
• Est. completion date: October 2018

Study information

• Verified date: April 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	University of Minnesota PM&R Department	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale		one week, one month, three months, six month, nine months, and twelve months
Secondary	Carpal Tunnel Syndrome Assessment Questionnaire		one week, one month, three months, six month, nine months, and twelve months