Intra-sheath vs Extra-sheath Injection for De Quervain's Tenosynovitis
Part of paid clinical trials in Sacramento, California.
- Sponsor
- University of California, Davis
- Study ID
- NCT04895956
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- De Quervain Tenosynovitis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Intra-sheath injection — PROCEDUREUltrasound guided corticosteroid injection composed of 1ml of 1% lidocaine and 1ml (20mg) of dexamethasone. Injection will be administered directly into the abductor pollicis longus/ extensor pollicis brevis sheath.
- Extra-sheath injection — PROCEDUREUltrasound guided corticosteroid injection composed of 1ml of 1% lidocaine and 1ml (20mg) of dexamethasone. Injection will be administered surrounding the abductor pollicis longus/ extensor pollicis brevis sheath.
- Ultrasound — DEVICETo ensure accuracy of fluid deposition into the tendon sheath in the intra-sheath injection arm and outside of the tendon sheath in the extra-sheath injection arm, all injections will be performed under ultrasound guidance. The ultrasound machine used will be a portable ultrasound machine located at the UC Davis orthopaedic clinic in Sacramento
Study Details
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.
Key Dates
- Start date
- Jan 24, 2022
- Status verified
- Feb 2026
- Primary completion
- Jun 1, 2026
- Completion
- Jun 1, 2026
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Intra-sheath injectionIn patients randomized to the intra-sheath, corticosteroids will be injected directly into the abductor pollicis longus/ extensor pollicis brevis sheath.
- Experimental: Extra-sheath injectionIn patients randomized to the extra-sheath arm, corticosteroids will be injected surrounding the abductor pollicis longus/ extensor pollicis brevis sheath.
Primary Outcome Measure
Visual analog scale (VAS) at 6 weeks post injection [ Time Frame: 6 weeks ]
Central Contacts
- Julia Martin, MS916-7348175
- Christopher O Bayne, MD(916) 734-2700
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UC Davis Health, Department of Orthopaedics | Sacramento | California | 95817 |
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