De Quervain DiseaseNCT04260984
Effect of Ultrasound-guided Corticosteroid Injection Versus Palpation-guided Injection for de Quervain's Disease
A study testing US-guided injection and palpation-guided injection in people with De Quervain Disease, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- De Quervain Disease
- What is being tested?
- US-guided injection and palpation-guided injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Feb 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ultrasound-guided Corticosteroid Injection Versus Palpation-guided Injection for de Quervain's Disease: a Randomized Control Trial
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.
Read the 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.
- Conditions
- De Quervain Disease
- Being tested
- US-guided injection, palpation-guided injection
- Keywords
- De Quervain Disease, ultrasound-guided injection, intra-articular injection
- Medical subject headings
- De Quervain Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-guided injectionProcedure or surgery
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.
palpation-guided injectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: US-guided injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week after injection
Secondary outcomes (2)
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
Measured: beginning of the treatment and at 1 week ,3 months and 6 months after the beginning of the treatment.
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.
Measured: beginning of the treatment and at 1 week ,3 months and 6 months after the beginning of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start8 Feb 2020
- Primary completion30 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for De Quervain DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin-Fen Hsieh, Shin Kong Wu Ho-Su Memorial Hospital
- Investigators
- Lin-Fen Hsieh, M.D, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260984
- Sponsor's protocol ID
- 20190705R
- Other IDs
- 2020SKHADR036
- Status last verified
- Jan 2023
- First submitted
- 20 Jan 2020
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuo YC, Hsieh LF, Liu YF, Chang CS. Ultrasound versus palpation-guided corticosteroid injection for de Quervain disease: A randomized controlled trial. PM R. 2024 Sep;16(9):948-958. doi: 10.1002/pmrj.13144. Epub 2024 Apr 22.
PubMed 38647254
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-guided Corticosteroid Injection Versus Palpation-guided Injection for de Quervain's Disease: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04260984
- Acronym / sponsor ID
- 20190705R
- Conditions
- De Quervain Disease
- Keywords
- De Quervain Disease, ultrasound-guided injection, intra-articular injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- 8 Feb 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| palpation-guided injection | Active comparator | Procedure: palpation-guided injectionInjectate: 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. |
| US-guided injection | Active comparator | Procedure: US-guided injectionFor 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| US-guided injectionFor 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 or surgery | US-guided injection |
| palpation-guided injectionInjectate: 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 or surgery | palpation-guided injection |
Primary outcome
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
2 secondary outcomes
VAS pain
Time frame: beginning of the treatment and at 1 week ,3 months and 6 months after the beginning of the treatment.
Direct treatment response
Time frame: beginning of the treatment and at 1 week ,3 months and 6 months after the beginning of the treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Derived from this study: PubMed 38647254Kuo YC, Hsieh LF, Liu YF, Chang CS. Ultrasound versus palpation-guided corticosteroid injection for de Quervain disease: A randomized controlled trial. PM R. 2024 Sep;16(9):948-958. doi: 10.1002/pmrj.13144. Epub 2024 Apr 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin-Fen Hsieh, M.D principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US-guided injection and palpation-guided injection in people with De Quervain Disease, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QuickDASH (time frame: 1 week after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04260984, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.