Carpal Tunnel SyndromePhase 2NCT00701233
Botulinum Toxin for Carpal Tunnel Syndrome
A Phase 2 study testing Botulinum toxin and Corticosteroid injection into Carpal Tunnel in people with Carpal Tunnel Syndrome, run by University of Minnesota at 1 site in United States.
Trial summary
To compare local steroid injections to local Botulinum toxin A injection in a double-blinded study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Botulinum toxin and Corticosteroid injection into Carpal Tunnel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Oct 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota PM&R Department
Minneapolis, Minnesota, 55455
About this study
Official title: Evaluation of Intercarpal Botox Versus Steroid Injections for Carpal Tunnel Syndrome
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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Botulinum toxin, Corticosteroid injection into Carpal Tunnel
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxinDrug
45 units Botox injected into Carpal Tunnel once
Corticosteroid injection into Carpal TunnelDrug
40 mg Triamcinolone with one mL 1% lidocaine injected once into Carpal Tunnel
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Corticosteroid injection into Carpal Tunnel Receives: Drug: Corticosteroid injection into Carpal Tunnel |
| 1 | Active comparator | Botulinum toxin injection into Carpal Tunnel Receives: Drug: Botulinum toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Measured: one week, one month, three months, six month, nine months, and twelve months
Secondary outcomes (1)
Carpal Tunnel Syndrome Assessment Questionnaire
Measured: one week, one month, three months, six month, nine months, and twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startJun 2012
- Primary completionOct 2018
- Study completionOct 2018 (estimated)
Why it stopped: Unable to generate MD's and patients for this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis Dykstra, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701233
- Sponsor's protocol ID
- 0708M13705
- Status last verified
- Apr 2019
- First submitted
- 17 Jun 2008
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intercarpal Botox Versus Steroid Injections for Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT00701233
- Acronym / sponsor ID
- 0708M13705
- Conditions
- Carpal Tunnel Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to generate MD's and patients for this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (estimated)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: Corticosteroid injection into Carpal TunnelCorticosteroid injection into Carpal Tunnel |
| 1 | Active comparator | Drug: Botulinum toxinBotulinum toxin injection into Carpal Tunnel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin45 units Botox injected into Carpal Tunnel once | Drug | 1 |
| Corticosteroid injection into Carpal Tunnel40 mg Triamcinolone with one mL 1% lidocaine injected once into Carpal Tunnel | Drug | 2 |
Primary outcome
Visual Analog Scale
Time frame: one week, one month, three months, six month, nine months, and twelve months
1 secondary outcome
Carpal Tunnel Syndrome Assessment Questionnaire
Time frame: one week, one month, three months, six month, nine months, and twelve months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Dykstra, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum toxin and Corticosteroid injection into Carpal Tunnel in people with Carpal Tunnel Syndrome, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: one week, one month, three months, six month, nine months, and twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.