NCT04895956 Intra-sheath vs Extra-sheath Injection for De Quervain's Tenosynovitis
| NCT ID | NCT04895956 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, Davis |
| Condition | De Quervain Tenosynovitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-01-24 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2022-01-24 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the study is to determine whether or not extra-sheath steroid injections are inferior to intra-sheath steroid injections in the treatment of DeQuervain's Tenosynovitis. Patients will be randomized to either the intra-sheath group or the extra-sheath group and their pre-injection level of pain will be assessed using the visual analog scale. Appropriate injections will then be administered by 1 of 3 UC Davis hand surgeons. Six weeks post injection the patients will be reassessed using the visual analog scale and their score at 6 weeks will be compared to their pre-injection score.
Eligibility Criteria
Inclusion Criteria: * Signed informed consent from the patient exclusively and not a legal representative * Clinically diagnosed with De Quervain's * VAS score of at least 40mm pre-injection * Life expectancy greater than 1 year Exclusion Criteria: * Having previously undergone steroid injection in the treatment of De Quervain's * Having previously undergone surgery for De Quervain's in the affected wrist * Having previously undergone steroid injection and failed in the treatment of trigger finger * Allergies to lidocaine or dexamethasone * Underlying serious medical conditions that would place the patient at risk * Past history of hypothyroidism or rheumatoid arthritis * Pregnant women * Prisoners
Contact & Investigator
Christopher O Bayne, MD
PRINCIPAL INVESTIGATOR
University of California, Davis
Frequently Asked Questions
Who can join the NCT04895956 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying De Quervain Tenosynovitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04895956 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04895956 currently recruiting?
Yes, NCT04895956 is actively recruiting participants. Contact the research team at jyhmartin@ucdavis.edu for enrollment information.
Where is the NCT04895956 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT04895956 clinical trial?
NCT04895956 is sponsored by University of California, Davis. The principal investigator is Christopher O Bayne, MD at University of California, Davis. The trial plans to enroll 80 participants.