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WithdrawnNCT00701233Updated Apr 17, 2019

Botulinum Toxin for Carpal Tunnel Syndrome

A Phase 2 interventional study of Botulinum toxin and Corticosteroid injection into Carpal Tunnel in Carpal Tunnel Syndrome, sponsored by University of Minnesota. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-17.

Sponsored by University of Minnesota · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Unable to generate MD's and patients for this study
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Carpal Tunnel Syndrome
03

In context

Carpal Tunnel Syndrome

605 studies on the registry are indexed under Carpal Tunnel Syndrome; 138 are open to participants now.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,210 studies on the registry; 195 are open to participants now.

Of its 133 completed or terminated interventional studies of FDA-regulated products, 92 (69%) have results posted.

Browse University of Minnesota studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    2

    Corticosteroid injection into Carpal Tunnel

    Drug: Corticosteroid injection into Carpal Tunnel

  • Active comparator
    1

    Botulinum toxin injection into Carpal Tunnel

    Drug: Botulinum toxin

Interventions

  • DrugBotulinum toxin

    45 units Botox injected into Carpal Tunnel once

  • DrugCorticosteroid injection into Carpal Tunnel

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

06

What researchers measure

Primary outcomes

  1. Visual Analog Scale

    Time frame: one week, one month, three months, six month, nine months, and twelve months

Secondary outcomes

  1. Carpal Tunnel Syndrome Assessment Questionnaire

    Time frame: one week, one month, three months, six month, nine months, and twelve months

07

Study locations

1 site
  • University of Minnesota PM&R Department
    Minneapolis, Minnesota 55455, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2012, a primary completion of Oct 2018 and a completion of Oct 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 17, 2008
First posted
Jun 19, 2008
Start
Jun 2012
Primary completionActual
Oct 2018
CompletionEst.
Oct 2018
Last update
Apr 17, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00701233
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Jun 19, 2008
Start date
Jun 2012
Primary completion
Oct 2018
Completion
Oct 2018 (estimated)
Last update
Apr 17, 2019

Study contacts

Dennis Dykstra, MD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Botulinum Toxins

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