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

Primary Purpose

De Quervain Disease

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
US-guided injection
palpation-guided injection
Sponsored by
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for De Quervain Disease focused on measuring De Quervain Disease, ultrasound-guided injection, intra-articular injection

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shin Kong Wu Ho-Su Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

palpation-guided injection

US-guided injection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

VAS pain
The patient or the assessor recorded the level of perceived pain by making a vertical mark between the 2 ends of a 10-cm horizontal line. The 0-cm point would represent no pain, while the 10-cm end represents the most extreme pain imaginable. The distance from 0cm to the mark was measured. The reliability of VAS for pain is .94.19
Direct treatment response
Direct treatment response includes 4 grades: grade 1 is no response, very unsatisfactory; grade 2, partial response, not satisfactory, need further therapy; grade 3, partial response, satisfactory, not warranting further therapy; grade 4, complete symptom relief, very satisfactory.20 Improvement as perceived by patients using a 5-point Likert scale: 1, much worse; 2, worse; 3, same; 4, better; 5, much better.

Full Information

First Posted
January 20, 2020
Last Updated
January 17, 2023
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04260984
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 8, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
De Quervain Disease
Keywords
De Quervain Disease, ultrasound-guided injection, intra-articular injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
palpation-guided injection
Arm Type
Active Comparator
Arm Description
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.
Arm Title
US-guided injection
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
US-guided injection
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
palpation-guided injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
QuickDASH
Description
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
Time Frame
1 week after injection
Secondary Outcome Measure Information:
Title
VAS pain
Description
The patient or the assessor recorded the level of perceived pain by making a vertical mark between the 2 ends of a 10-cm horizontal line. The 0-cm point would represent no pain, while the 10-cm end represents the most extreme pain imaginable. The distance from 0cm to the mark was measured. The reliability of VAS for pain is .94.19
Time Frame
beginning of the treatment and at 1 week ,3 months and 6 months after the beginning of the treatment.
Title
Direct treatment response
Description
Direct treatment response includes 4 grades: grade 1 is no response, very unsatisfactory; grade 2, partial response, not satisfactory, need further therapy; grade 3, partial response, satisfactory, not warranting further therapy; grade 4, complete symptom relief, very satisfactory.20 Improvement as perceived by patients using a 5-point Likert scale: 1, much worse; 2, worse; 3, same; 4, better; 5, much better.
Time Frame
beginning of the treatment and at 1 week ,3 months and 6 months after the beginning of the treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin-Fen Hsieh, M.D
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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