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Steroid Injections for De Quervain's Syndrome
Phase 4
Recruiting
Led By Christopher O Bayne, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinically diagnosed with De Quervain's
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will help determine if extra-sheath steroid injections are inferior to intra-sheath steroid injections in the treatment of DeQuervain's Tenosynovitis.
Who is the study for?
This trial is for individuals with De Quervain's Tenosynovitis, who have a pain level of at least 40mm on the visual analog scale and expect to live more than a year. They must not have allergies to lidocaine or dexamethasone, no past wrist surgeries for this condition, no serious medical risks, and cannot be prisoners or pregnant.Check my eligibility
What is being tested?
The study compares two methods of steroid injection treatment for De Quervain's Tenosynovitis: one directly into the tendon sheath (intra-sheath) and another outside it (extra-sheath). Patients will be randomly assigned to either group and their pain levels measured before and six weeks after treatment.See study design
What are the potential side effects?
Possible side effects from the injections may include reactions at the injection site like pain, swelling, infection risk increase; allergic reactions to medications used; temporary increase in blood sugar levels; tendon weakening or rupture.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with De Quervain's.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Visual analog scale (VAS) at 6 weeks post injection
Secondary outcome measures
Presence or absence of separate abductor pollicis longus and extensor pollicis brevis subsheaths
Shortened disabilities of the hand arm and shoulder (quickDASH) scores at 1 year post injection
Shortened disabilities of the hand arm and shoulder (quickDASH) scores at 6 months post injection
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Extra-sheath injectionExperimental Treatment2 Interventions
In patients randomized to the extra-sheath arm, corticosteroids will be injected surrounding the abductor pollicis longus/ extensor pollicis brevis sheath.
Group II: Intra-sheath injectionActive Control2 Interventions
In patients randomized to the intra-sheath, corticosteroids will be injected directly into the abductor pollicis longus/ extensor pollicis brevis sheath.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound
2013
Completed Phase 1
~1950
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,439 Total Patients Enrolled
Christopher O Bayne, MDPrincipal InvestigatorUniversity of California, Davis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have serious health issues that could make treatment risky.I have been diagnosed with De Quervain's.I have had a steroid injection for De Quervain's.I have had hypothyroidism or rheumatoid arthritis in the past.I had surgery for De Quervain's on my wrist.I tried steroid injections for my trigger finger, but they didn't work.You are expected to live for at least one more year.You are currently pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Intra-sheath injection
- Group 2: Extra-sheath injection
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Is the recruitment phase of this clinical trial still in progress?
"As of today, the study is still recruiting participants. The original posting occurred on January 24th 2022 and was last edited just over two weeks later (February 7th)."
Answered by AI
How many people are participating in this clinical research?
"Indeed, the information posted on clinicaltrials.gov reveals that this experiment is presently enrolling volunteers. The trial was first made public on January 24th 2022 and has been modified as recently as February 7th 2022. This research seeks to recruit 80 participants from 1 location."
Answered by AI
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