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Neurotoxin
Botox Injections for Thumb Arthritis
Phase 3
Recruiting
Research Sponsored by Rhode Island Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-weeks, 1-month, 6-months, and 1-year (primary study endpoint).
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of Botox as a treatment for thumb joint pain/arthritis.
Who is the study for?
This trial is for adults over 18 with thumb joint pain or arthritis who haven't improved after at least 3 months of oral pain meds and splinting. It's not for those with severe arthritis, other hand conditions, past significant hand trauma, pregnancy, or plans to conceive soon.Check my eligibility
What is being tested?
The study compares the safety and effectiveness of botulinum toxin (Botox) injections versus standard steroid injections in treating thumb joint pain/arthritis. Botox is investigational and not FDA-approved for this use.See study design
What are the potential side effects?
Potential side effects may include weakness in muscles near the injection site, pain at the injection site, flu-like symptoms, and allergic reactions. Long-term effects are unknown since Botox isn't yet approved for this condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-weeks, 1-month, 6-months, and 1-year (primary study endpoint).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-weeks, 1-month, 6-months, and 1-year (primary study endpoint).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Thumb Pain
Secondary outcome measures
Grip Strength
Thumb range of motion
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Botulinum ToxinExperimental Treatment1 Intervention
Patients in this group will receive a Botulinum Toxin injection.
Group II: ControlActive Control1 Intervention
Patients in this group will receive standard-of-care corticosteroid injections.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum toxin
2016
Completed Phase 4
~180
Find a Location
Who is running the clinical trial?
Rhode Island HospitalLead Sponsor
260 Previous Clinical Trials
66,957 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've tried pain medication and splinting for over 3 months without improvement.I have pain, stiffness, or changes in shape or movement in my thumb joint.I have inflammatory arthritis.My severe arthritis or bone spurs prevent joint injections.I have been diagnosed with fibromyalgia or CRPS.I experience pain or stiffness in my thumb or wrist.I am over 18 and have thumb arthritis.I have had hand surgery or treatment before.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Botulinum Toxin
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum patient capacity of this trial?
"That is accurate. Clinicaltrials.gov details that this experiment, which was posted on August 27th 2023, is currently recruiting people for participation. The trial site requires 50 participants to enrol at one location."
Answered by AI
Is there any evidence of adverse effects linked to Botulinum Toxin treatments?
"There is extant clinical evidence that suggests the safety of Botulinum Toxin, so it was awarded a score of 3."
Answered by AI
Are there any extant opportunities for patients to participate in this trial?
"Affirmative. According to clinicaltrials.gov, this trial is still seeking candidates; it was posted on August 27th 2023 and revised on the 10th of August in the same year. 50 participants are required at a single site for successful completion of the study."
Answered by AI
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