Botulinum Toxin for Carpal Tunnel Syndrome

Phase 2

Withdrawn

• Conditions: Carpal Tunnel Syndrome
• Interventions: Drug: Corticosteroid injection into Carpal Tunnel; Drug: Botulinum toxin

• Registration Number: NCT00701233
• Lead Sponsor: University of Minnesota

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 Timeline

• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-19
• Study Start: 2012-06
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Corticosteroid injection into Carpal Tunnel	Corticosteroid injection into Carpal Tunnel
1	Botulinum toxin	Botulinum toxin injection into Carpal Tunnel

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale	one week, one month, three months, six month, nine months, and twelve months

Secondary Outcome Measures

Name	Time	Method
Carpal Tunnel Syndrome Assessment Questionnaire	one week, one month, three months, six month, nine months, and twelve months

Trial Locations

Locations (1)

University of Minnesota PM&R Department; 🇺🇸 Minneapolis, Minnesota, United States