RecruitingPhase 4NCT04895956

Intra-sheath vs Extra-sheath Injection for De Quervain's Tenosynovitis


Sponsor

University of California, Davis

Enrollment

80 participants

Start Date

Jan 24, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two methods of delivering a steroid injection for De Quervain's tenosynovitis — a painful condition causing inflammation in the tendons on the thumb side of the wrist. Researchers want to know whether injecting within the tendon sheath (intra-sheath) or just outside it (extra-sheath) gives better pain relief. **You may be eligible if...** - You have been clinically diagnosed with De Quervain's tenosynovitis - Your pain level is at least 40 out of 100 mm on a visual analog pain scale before the injection - You have a life expectancy of more than 1 year - You have not previously had a steroid injection for this condition **You may NOT be eligible if...** - You have already had a steroid injection or surgery for De Quervain's in the same wrist - You have had a failed steroid injection for trigger finger in the past - You are allergic to lidocaine or dexamethasone - You have hypothyroidism or rheumatoid arthritis - You are pregnant Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIntra-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.

PROCEDUREExtra-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.

DEVICEUltrasound

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


Locations(1)

UC Davis Health, Department of Orthopaedics

Sacramento, California, United States

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NCT04895956