Clinical trial NCT04260984: Effect of Ultrasound-guided Corticosteroid Injection Versus Palpation-guided Injection for de Quervain's Disease
Official title: Effect of Ultrasound-guided Corticosteroid Injection Versus Palpation-guided Injection for de Quervain's Disease: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: De Quervain Disease
Keywords: De Quervain Disease
ultrasound-guided injection
intra-articular injection
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of this study are to compare the effectiveness and side effects of US-guided and palpation-guided corticosteroid injections for de Quervain's disease.

Detailed description: De Quervain's disease is a common clinical disorder, characterized by pain at radial side of the wrist. It often interferes wrist and thumb movement, and may affect activity of daily life. It is caused by overuse and impaired gliding of the abductor pollicis longus (APL) and extensor policis brevis (EPB) tendons at the styloid process of the radius. It is associated with postpartum baby care, or jobs or hobbies that involve repetitive hand and wrist motions. The most effective treatment is corticosteroid injection into the tendon sheath of the conjoined tendons of APL and EPB. Over the past few years because of advancement of sonography in the musculoskeletal system, ultrasound (US)-guided intra-sheath injection has become popular, and it has been proved to improve the accuracy of placement of needle tip in the tendon sheath, however, studies comparing the effect and side effects of US-guided corticosteroid injection with palpation-guided injection for de Quervain's disease have never been reported before. The purposes of this study are to compare the effectiveness and side effects of US-guided and palpation-guided corticosteroid injections for de Quervain's disease.

The investigators plan to recruit 70 patients with de Quervain's disease, half of them will be randomly assigned into US-guided injection group, and the other half into the palpation-guided injection group. Each subject will receive one shot of injection and each subject will expect to fill in the evaluation form at baseline, and at 1 week, 3 months, and 6 months after the injection. Statistics will be performed after completing the patients' treatment and evaluations.

Eligibility criteria: Inclusion Criteria:

1. Pain and tenderness at the radial side of the wrist.
2. Positive Finkelstein sign, or pain on resistive maximal isometric contraction of extension and/or abduction of the affected thumb.
3. pain intensity on a 10-point visual analog scale (VAS) for pain to ≧ 3 on active thumb abduction or extension.
4. Patient agrees to receive either palpation-guided or US-guided local corticosteroid injection.
5. Age ≧ 20 years old.

Exclusion Criteria:

1. Presence of an absolute contraindication for corticosteroids or local anesthetics injection.
2. During pregnancy.
3. Severe systemic diseases with poor control.
4. Prior treatment with corticosteroid injection and/or surgery at the same anatomical location in the last 6 months.
5. Being unable to fill-in the follow-up forms.

Primary outcomes:
measure: QuickDASH
timeFrame: 1 week after injection
Secondary outcomes:
measure: VAS pain
timeFrame: beginning of the treatment and at 1 week ,3 months and 6 months after the beginning of the treatment.
measure: Direct treatment response
timeFrame: beginning of the treatment and at 1 week ,3 months and 6 months after the beginning of the treatment.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Lin-Fen Hsieh, M.D
role: PRINCIPAL_INVESTIGATOR
References: