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Botulinum Toxin for Carpal Tunnel Syndrome

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status and phase

Withdrawn
Phase 2

Conditions

Carpal Tunnel Syndrome

Treatments

Drug: Botulinum toxin
Drug: Corticosteroid injection into Carpal Tunnel

Study type

Interventional

Funder types

Other

Identifiers

NCT00701233
0708M13705

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

0 participants in 2 patient groups

2
Active Comparator group
Description:
Corticosteroid injection into Carpal Tunnel
Treatment:
Drug: Corticosteroid injection into Carpal Tunnel
1
Active Comparator group
Description:
Botulinum toxin injection into Carpal Tunnel
Treatment:
Drug: Botulinum toxin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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