Recruiting

Intra-sheath vs. Extra-sheath

Sponsor:

UCLA

Code:

NCT04895956

Conditions

De Quervain Tenosynovitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intra-sheath injection

Extra-sheath injection

Ultrasound

Study Details

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.

Conditions

De Quervain Tenosynovitis

Study ID

NCT04895956

Start date

Jan 24, 2022

Status verified date

Jul, 2026

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intra-sheath injection

In patients randomized to the intra-sheath, corticosteroids will be injected directly into the abductor pollicis longus/ extensor pollicis brevis sheath.

experimental: Extra-sheath injection

In patients randomized to the extra-sheath arm, corticosteroids will be injected surrounding the abductor pollicis longus/ extensor pollicis brevis sheath.

Interventions

Intra-sheath injection

Ultrasound 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

Ultrasound 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

To 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

Primary outcome measure

  • Visual analog scale (VAS) at 6 weeks post injection [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Julia Martin, MS

916-7348175jyhmartin@ucdavis.edu

Christopher O Bayne, MD

(916) 734-2700cbayne@ucdavis.edu

Locations

UC Davis Health, Department of Orthopaedics

Recruiting

Sacramento, California, United States, 95817

Contacts

Julia Martin, MS

916-734-8175jyhmartin@ucdavis.edu

Christopher O Bayne, MD

(916) 734-2700cbayne@ucdavis.edu

More Information

Sponsor

University of California, Davis

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Steroid injection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-07-06.