DeQuervain's TenosynovitisPhase 4NCT02038634
Ultrasound-guided Injection for DeQuervain's
A Phase 4 study testing Betamethasone and Ultrasound in people with DeQuervain's Tenosynovitis, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The investigators aim to perform a prospective study to evaluate the effectiveness of blind corticosteroid injections to US-guided injections for the treatment of de Quervain's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DeQuervain's Tenosynovitis
- What is being tested?
- Betamethasone and Ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2014to 15 Mar 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain with palpation at 1st dorsal compartment at wrist and positive Finkelstein's Test
Who cannot join
- Patients with evidence of osteoarthritis or degeneration of the wrist.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aim to perform a prospective study to evaluate the effectiveness of blind corticosteroid injections to US-guided injections for the treatment of de Quervain's disease. The results of the study will be used to validate current injection protocols or support the incorporation of ultrasonography to treat the disease.
Read the detailed description
De Quervain's disease is the stenosing tenosynovitis and tendinitis of the abductor pollicis longus (APL) and extensor pollicis brevis (EPB) tendons in the first dorsal compartment of the wrist. While the prevalence of de Quervain's is not yet well-established, previous studies have shown that women can be affected by the disease up to six times more frequently than men. Conservative treatments include splinting and corticosteroid injections, but surgery is an option when such therapy fails. There has been a previous study that compared the improvement rates of patients treated with splinting alone, injection and splinting, and injection alone, and found the rate of improvement to be 19%, 57%, 67%, respectively. This confirmed the good results reported in previous studies and recommends corticosteroid injection to clinicians as a reliable treatment for de Quervain's disease.
A seminal study performed correlated the accuracy of corticosteroid injection with pain relief by including X-ray dye in the injection. The results of the study suggested a strong correlation between accurate injection of the first dorsal compartment and pain relief. Since then, the use of ultrasonography (US) to guide steroid injection has been suggested as a possible clinical practice, but little research has been done on the technique. A 2009 study reported a 93.75% rate of significant pain relief after the use of US-guided injections, but there was no control group with which to compare results. The current standard practice for steroid injection in de Quervain's patients is a blind injection without imaging guidance. To the investigators knowledge, no study has compared the accuracy and clinical outcomes of blind injections to US-guided injections. The investigators hypothesize that the US-guided injections will be and will result in greater pain relief for patients than blind injections.
This is intended to be a prospective study. Patients will contact Dr.'s Grindel and Daley for a standard clinical evaluation, which includes palpation of the first extensor compartment and application of the Finkelstein test. Those diagnosed with de Quervain's disease and who fit all inclusion criteria will receive a detailed verbal description of the study from one of the doctors, who will then attain written, informed consent from willing participants. Dr.'s Grindel or Daley will then administer either a blind or US-guided injection. The patient will return for follow-up appointments at 6-8 weeks and 12-16 weeks and will undergo another physical exam to determine pain relief. A phone call follow-up will also be placed one year after the injection in order to determine long-term effectiveness. Once 20 study subjects in each group (40 total) have been enrolled and completed treatment, the data will undergo statistical analysis.
This study poses minimal or no physical risk to study subjects, as the US-guided injection should show better pain relief for patients than the current standard treatment (blind injection).
In summary, the investigators aim to perform a prospective study to evaluate the effectiveness of blind corticosteroid injections to US-guided injections for the treatment of de Quervain's disease. The results of the study will be used to validate current injection protocols or support the incorporation of ultrasonography to treat the disease.
- Conditions
- DeQuervain's Tenosynovitis
- Being tested
- Betamethasone, Ultrasound
- Keywords
- wrist, tendonitis, dequervain's, tenosynovitis
- Medical subject headings
- Tendinopathy, Tenosynovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetamethasoneDrug
Also called celestone
UltrasoundDevice
Ultrasound guided injection using GE Healthcare LOGIQ e Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Unguided injections | Active comparator | Corticosteroid injection (betamethasone) without ultrasound guidance. Receives: Drug: Betamethasone |
| Ultrasound-guided injections | Active comparator | Corticosteroid injections (betamethasone) under ultrasound guidance. Receives: Drug: Betamethasone; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH - "Disabilities of the Arm, Shoulder, and Hand" Score At Baseline, and Change From Baseline at 6-8 Weeks, 12-16 Weeks, and at 1 Year
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire. Questions 1-30, the scale is a 1-5 scale (1=no difficulty; 2=mild difficulty; 3=moderate difficulty; 4=severe difficulty; 5=unable) DASH Disability/Symptom Score = [(sum of n responses)/n) -1] x 25. A lower score is a better outcome. The Dash is based on a scale of 0-100. Our scores were averaged and the Mean scores are what we reported. Total scores are listed below.
US Guided Group - Dash #1 (Min=25, Mean=58, Max=90) n=12; Dash #2 (Min=3, Mean=38, Max=91) n=12; Dash #3 (Min=6, Mean=42, Max=71) n=10; 1 Year Dash (Min=0, Mean =29, Max=91) n=12.
Non-US Guided Group - Dash #1 (Min=23, Mean=39, Max=61) n=3; Dash #2 (Min=0, Mean=11, Max=22) n=3; Dash #3 (Min=7, Mean=30, Max=49) n=3; 1 Year Dash (Min=0, Mean=9, Max=25) n=3.
Measured: Prior to injection (Dash #1), 6-8 weeks (Dash #2), 12-16 weeks (Dash #3), and 1 year (Dash #4) post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study start5 Aug 2014
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Why it stopped: not enough patient data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DeQuervain's TenosynovitisStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Grindel, Medical College of Wisconsin
- Investigators
- Steven Grindel, MD, Principal investigator, MCW/Froedtert Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038634
- Sponsor's protocol ID
- PRO20646
- Status last verified
- Nov 2022
- First submitted
- 25 Sep 2013
- Last updated
- 28 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: We have no plan to share the data we have collected with any other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Injection for DeQuervain's
- ClinicalTrials.gov ID
- NCT02038634
- Acronym / sponsor ID
- PRO20646
- Conditions
- DeQuervain's Tenosynovitis
- Keywords
- wrist, tendonitis, dequervain's, tenosynovitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patient data
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 5 Aug 2014 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Posted 28 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to perform a prospective study to evaluate the effectiveness of blind corticosteroid injections to US-guided injections for the treatment of de Quervain's disease. The results of the study will be used to validate current injection protocols or support the incorporation of ultrasonography to treat the disease.
Detailed description
De Quervain's disease is the stenosing tenosynovitis and tendinitis of the abductor pollicis longus (APL) and extensor pollicis brevis (EPB) tendons in the first dorsal compartment of the wrist. While the prevalence of de Quervain's is not yet well-established, previous studies have shown that women can be affected by the disease up to six times more frequently than men. Conservative treatments include splinting and corticosteroid injections, but surgery is an option when such therapy fails. There has been a previous study that compared the improvement rates of patients treated with splinting alone, injection and splinting, and injection alone, and found the rate of improvement to be 19%, 57%, 67%, respectively. This confirmed the good results reported in previous studies and recommends corticosteroid injection to clinicians as a reliable treatment for de Quervain's disease.
A seminal study performed correlated the accuracy of corticosteroid injection with pain relief by including X-ray dye in the injection. The results of the study suggested a strong correlation between accurate injection of the first dorsal compartment and pain relief. Since then, the use of ultrasonography (US) to guide steroid injection has been suggested as a possible clinical practice, but little research has been done on the technique. A 2009 study reported a 93.75% rate of significant pain relief after the use of US-guided injections, but there was no control group with which to compare results. The current standard practice for steroid injection in de Quervain's patients is a blind injection without imaging guidance. To the investigators knowledge, no study has compared the accuracy and clinical outcomes of blind injections to US-guided injections. The investigators hypothesize that the US-guided injections will be and will result in greater pain relief for patients than blind injections.
This is intended to be a prospective study. Patients will contact Dr.'s Grindel and Daley for a standard clinical evaluation, which includes palpation of the first extensor compartment and application of the Finkelstein test. Those diagnosed with de Quervain's disease and who fit all inclusion criteria will receive a detailed verbal description of the study from one of the doctors, who will then attain written, informed consent from willing participants. Dr.'s Grindel or Daley will then administer either a blind or US-guided injection. The patient will return for follow-up appointments at 6-8 weeks and 12-16 weeks and will undergo another physical exam to determine pain relief. A phone call follow-up will also be placed one year after the injection in order to determine long-term effectiveness. Once 20 study subjects in each group (40 total) have been enrolled and completed treatment, the data will undergo statistical analysis.
This study poses minimal or no physical risk to study subjects, as the US-guided injection should show better pain relief for patients than the current standard treatment (blind injection).
In summary, the investigators aim to perform a prospective study to evaluate the effectiveness of blind corticosteroid injections to US-guided injections for the treatment of de Quervain's disease. The results of the study will be used to validate current injection protocols or support the incorporation of ultrasonography to treat the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unguided injections | Active comparator | Drug: BetamethasoneCorticosteroid injection (betamethasone) without ultrasound guidance. |
| Ultrasound-guided injections | Active comparator | Drug: Betamethasone, Device: UltrasoundCorticosteroid injections (betamethasone) under ultrasound guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pain with palpation at 1st dorsal compartment at wrist and positive Finkelstein's Test
Key exclusion criteria (1 listed)
- Patients with evidence of osteoarthritis or degeneration of the wrist.
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 |
|---|---|---|
| BetamethasoneAlso: celestone | Drug | Ultrasound-guided injections, Unguided injections |
| UltrasoundUltrasound guided injection using GE Healthcare LOGIQ e Ultrasound | Device | Ultrasound-guided injections |
Primary outcome
DASH - "Disabilities of the Arm, Shoulder, and Hand" Score At Baseline, and Change From Baseline at 6-8 Weeks, 12-16 Weeks, and at 1 Year
Time frame: Prior to injection (Dash #1), 6-8 weeks (Dash #2), 12-16 weeks (Dash #3), and 1 year (Dash #4) post-injection
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire. Questions 1-30, the scale is a 1-5 scale (1=no difficulty; 2=mild difficulty; 3=moderate difficulty; 4=severe difficulty; 5=unable) DASH Disability/Symptom Score = [(sum of n responses)/n) -1] x 25. A lower score is a better outcome. The Dash is based on a scale of 0-100. Our scores were averaged and the Mean scores are what we reported. Total scores are listed below. US Guided Group - Dash #1 (Min=25, Mean=58, Max=90) n=12; Dash #2 (Min=3, Mean=38, Max=91) n=12; Dash #3 (Min=6, Mean=42, Max=71) n=10; 1 Year Dash (Min=0, Mean =29, Max=91) n=12. Non-US Guided Group - Dash #1 (Min=23, Mean=39, Max=61) n=3; Dash #2 (Min=0, Mean=11, Max=22) n=3; Dash #3 (Min=7, Mean=30, Max=49) n=3; 1 Year Dash (Min=0, Mean=9, Max=25) n=3.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. We have no plan to share the data we have collected with any other researchers.
Related trials for DeQuervain's Tenosynovitis
Not yet recruitingObservational study
Early Functional Response as a Predictor of Clinical Outcomes in Hand Rehabilitation: A Prospective Feasibility Study Using a Digital Monitoring System
Hand, Hand Therapy
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.
Steven Grindel, MD principal investigator
MCW/Froedtert Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Betamethasone and Ultrasound in people with DeQuervain's Tenosynovitis, run by Medical College of Wisconsin at 1 site in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 28 Dec 2022. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
DASH - "Disabilities of the Arm, Shoulder, and Hand" Score At Baseline, and Change From Baseline at 6-8 Weeks, 12-16 Weeks, and at 1 Year (time frame: Prior to injection (Dash #1), 6-8 weeks (Dash #2), 12-16 weeks (Dash #3), and 1 year (Dash #4) post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2022.