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

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ClinicalTrials.gov Identifier: NCT04260984
Recruitment Status : Recruiting
First Posted : February 7, 2020
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Shin Kong Wu Ho-Su Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
De Quervain Disease Procedure: US-guided injection Procedure: palpation-guided injection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Ultrasound-guided Corticosteroid Injection Versus Palpation-guided Injection for de Quervain's Disease: a Randomized Control Trial
Actual Study Start Date : January 16, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Active Comparator: palpation-guided injection
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
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.

Active Comparator: US-guided injection
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
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.




Primary Outcome Measures :
  1. QuickDASH [ Time Frame: 1 week after injection ]
    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 :
  1. VAS pain [ Time Frame: beginning of the treatment and at 1 week ,3 months and 6 months after the beginning of the treatment. ]
    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

  2. Direct treatment response [ Time Frame: beginning of the treatment and at 1 week ,3 months and 6 months after the beginning of the treatment. ]
    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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04260984


Contacts
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Contact: Lin-Fen Hsieh, M.D +886-28332211 ext #2538 reh6110@yahoo.com.tw

Locations
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Taiwan
Shin Kong Wu Ho-Su Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Lin-Fen Hsieh, M.D    +886-28332211 ext 2538    M001026@ms.skh.org.tw   
Sponsors and Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
Investigators
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Principal Investigator: Lin-Fen Hsieh, M.D Shin Kong Wu Ho-Su Memorial Hospital
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Responsible Party: Shin Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier: NCT04260984    
Other Study ID Numbers: 20190705R
2020SKHADR036 ( Other Grant/Funding Number: Shin Kong Wu Ho-Su Memorial Hospital )
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shin Kong Wu Ho-Su Memorial Hospital:
De Quervain Disease
ultrasound-guided injection
intra-articular injection
Additional relevant MeSH terms:
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De Quervain Disease
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases