Botulinum Toxin for Carpal Tunnel Syndrome

NCT00701233 | Withdrawn Phase 2 DMC

• 1 other identifier: 0708M13705
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  one week, one month, three months, six month, nine months, and twelve months

Secondary Outcomes (1)

• Carpal Tunnel Syndrome Assessment Questionnaire

  one week, one month, three months, six month, nine months, and twelve months

Study Arms (2)

2

ACTIVE COMPARATOR

Corticosteroid injection into Carpal Tunnel

Drug: Corticosteroid injection into Carpal Tunnel

1

ACTIVE COMPARATOR

Botulinum toxin injection into Carpal Tunnel

Drug: Botulinum toxin

Interventions

Botulinum toxin DRUG

45 units Botox injected into Carpal Tunnel once

1

Corticosteroid injection into Carpal Tunnel DRUG

40 mg Triamcinolone with one mL 1% lidocaine injected once into Carpal Tunnel

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota PM&R Department

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Dennis Dykstra, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 19, 2008
• Study Start: June 1, 2012
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

US (1)