Effect of Ultrasound-guided Corticosteroid Injection Versus Palpation-guided Injection for de Quervain's Disease

NCT04260984 | Completed DMC

• 2 other identifiers: 20190705R2020SKHADR036
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

De Quervain Disease

Keywords

De Quervain Disease; ultrasound-guided injection; intra-articular injection

Outcome Measures

Primary Outcomes (1)

• QuickDASH

  QuickDASH is a self-report questionnaire comprising 11 items that focuses on symptoms and the ability to perform certain upper extremity activities on a five-point Likert-type scale. The scores range from 0 (the best) to 100 (the worst). The reliability of QuickDASH was 0.93, and the validity based on response of full-length DASH was 0.96.18

  1 week after injection

Secondary Outcomes (2)

• VAS pain

  beginning of the treatment and at 1 week ,3 months and 6 months after the beginning of the treatment.

• Direct treatment response

  beginning of the treatment and at 1 week ,3 months and 6 months after the beginning of the treatment.

Study Arms (2)

palpation-guided injection

ACTIVE COMPARATOR

Injectate: a mixture of 10mg triamcinolone acetonide (10mg/1ml) and 0.3ml 1% lidocaine. For palpation-guided injection, a 2.5cm 25-gauge needle will be inserted almost horizontally between APL and EPB tendons, just distal to the radial styloid, at the site of maximum tenderness. Then the mixture of triamcinolone and lidocaine will be pushed into the common tendon sheath.

Procedure: palpation-guided injection

US-guided injection

ACTIVE COMPARATOR

For US-guided injection, a 22 MHZ linear array probe (Esaote MyLab™ClassC, Italy) will be used for guidance of injection via a transverse scan, in-plane approach. After sterilization, the probe will be placed at the radial styloid with maximal swelling or tenderness. Then a 2.5 cm 25-gauge needle will be placed into the tendon sheath via transverse scan, in-the-plane approach, and the injectate will be pushed into the tendon sheath. Care will be taken avoiding injury of vessels and the superficial branch of radial nerve during the injection.

Procedure: US-guided injection

Interventions

US-guided injection PROCEDURE

For US-guided injection, a 22 MHZ linear array probe (Esaote MyLab™ClassC, Italy) will be used for guidance of injection via a transverse scan, in-plane approach. After sterilization, the probe will be placed at the radial styloid with maximal swelling or tenderness. Then a 2.5 cm 25-gauge needle will be placed into the tendon sheath via transverse scan, in-the-plane approach, and the injectate will be pushed into the tendon sheath. Care will be taken avoiding injury of vessels and the superficial branch of radial nerve during the injection.

US-guided injection

palpation-guided injection PROCEDURE

Injectate: a mixture of 10mg triamcinolone acetonide (10mg/1ml) and 0.3ml 1% lidocaine. For palpation-guided injection, a 2.5cm 25-gauge needle will be inserted almost horizontally between APL and EPB tendons, just distal to the radial styloid, at the site of maximum tenderness. Then the mixture of triamcinolone and lidocaine will be pushed into the common tendon sheath.

palpation-guided injection

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

De Quervain Disease

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Lin-Fen Hsieh, M.D

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: February 7, 2020
• Study Start: February 8, 2020
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)