de Quervain's DiseaseNCT02442622
Effectiveness of Astym Treatment For de Quervain's Tenosynovitis
A study testing Occupational therapy and Occupational therapy with ASTYM in people with de Quervain's Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
To determine if the addition of Astym treatment to traditional therapy produces a more positive outcome then traditional therapy alone for the treatment of de Quervain's tenosynvitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- de Quervain's Disease
- What is being tested?
- Occupational therapy and Occupational therapy with ASTYM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 29 Apr 2019
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive Finkelstein's test: The client will report pain over the first compartment of the extensor retinaculum when the thumb is tucked in the hand and deviated ulnarly.
- Persistent symptoms for >3 wks which have not resolved after an additional 3 weeks of splinting
- A diagnosis by a physician of "de Quervain's", "fist compartment tenosynovitis", or "radial styloid tenosynovitis"
- Patients must agree and comply to a predetermined splinting regimen
Who cannot join
- History of cortical steroid injection to affected wrist and/or thumb
- History of previous wrist trauma to affected limb
- Comorbidity such as carpal tunnel syndrome (CTS), radial tunnel syndrome, osteoarthritis, rheumatoid arthritis, auto-immune disease or inflammatory conditions, lateral epicondylitis or tendinopathies
- Clotting deficits
- Positive Cozen's sign which would indicate intersection syndrome
- Post-partum mothers <6 months and pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center, Center for Musculoskeletal Care
New York, New York, 10016
About this study
To determine if the addition of Astym treatment to traditional therapy produces a more positive outcome then traditional therapy alone for the treatment of de Quervain's tenosynvitis. Two groups will be examined with one group receiving traditional therapy and the other group receiving traditional therapy in addition to Astym treatment protocol.
- Conditions
- de Quervain's Disease
- Being tested
- Occupational therapy, Occupational therapy with ASTYM
- Keywords
- de Quervain's disease, de Quervain's tenosynovitis., ASTYM, de Quervain's treatment
- 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.
Occupational therapyOther
Occupational therapy for de Quervain's Tenosynovitis
Occupational therapy with ASTYMDevice
Occupational therapy for de Quervain's Tenosynovitis plus ASTYM
| Study group | Role | What they receive |
|---|---|---|
| Occupational therapy | Active comparator | Traditional therapy for de Quervain's Tenosynovitis Receives: Other: Occupational therapy |
| Occupational therapy with ASTYM | Experimental | Traditional therapy for de Quervain's Tenosynovitis plus ASTYM Receives: Device: Occupational therapy with ASTYM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale for Pain
This scale is a single point scale from 0-10. The participant picks one number to represent their pain, where 0 represents no pain and 10 represents worst pain imaginable.
Measured: 4.5 months
Secondary outcomes (2)
Sequential Occupational Dexterity Assessment (SODA) Score
This is a test to measure dexterity and bimanual abilities in activities of daily living. It includes 12 tasks with participants being scored on their ability, difficulty and pain during the task. Scores on the individual tasks are summed, and the range of the total SODA score is 0-108. A higher score indicates a higher dexterity.
Measured: 1.5 months
Quick Dash Score
It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity level/ function level. QuickDASH Scoring Formula = ([(sum of n responses)/n] -1)(25) where n represents the number of completed items. Higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score on both test ranges from 0 (no disability) to 100 (most severe disability).
Measured: 4.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startJan 2015
- Primary completion29 Apr 2019
- Study completion29 Apr 2019
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 de Quervain's DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen VanLew, PhD, OTR/L, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442622
- Sponsor's protocol ID
- 14-01059
- Status last verified
- Sep 2020
- First submitted
- 8 May 2015
- Last updated
- 9 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Astym Treatment For de Quervain's Tenosynovitis
- ClinicalTrials.gov ID
- NCT02442622
- Acronym / sponsor ID
- 14-01059
- Conditions
- de Quervain's Disease
- Keywords
- de Quervain's disease, de Quervain's tenosynovitis., ASTYM, de Quervain's treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 29 Apr 2019 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Posted 9 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if the addition of Astym treatment to traditional therapy produces a more positive outcome then traditional therapy alone for the treatment of de Quervain's tenosynvitis. Two groups will be examined with one group receiving traditional therapy and the other group receiving traditional therapy in addition to Astym treatment protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occupational therapy | Active comparator | Other: Occupational therapyTraditional therapy for de Quervain's Tenosynovitis |
| Occupational therapy with ASTYM | Experimental | Device: Occupational therapy with ASTYMTraditional therapy for de Quervain's Tenosynovitis plus ASTYM |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Positive Finkelstein's test: The client will report pain over the first compartment of the extensor retinaculum when the thumb is tucked in the hand and deviated ulnarly.
- Persistent symptoms for >3 wks which have not resolved after an additional 3 weeks of splinting
- A diagnosis by a physician of "de Quervain's", "fist compartment tenosynovitis", or "radial styloid tenosynovitis"
- Patients must agree and comply to a predetermined splinting regimen
Key exclusion criteria (6 listed)
- History of cortical steroid injection to affected wrist and/or thumb
- History of previous wrist trauma to affected limb
- Comorbidity such as carpal tunnel syndrome (CTS), radial tunnel syndrome, osteoarthritis, rheumatoid arthritis, auto-immune disease or inflammatory conditions, lateral epicondylitis or tendinopathies
- Clotting deficits
- Positive Cozen's sign which would indicate intersection syndrome
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 |
|---|---|---|
| Occupational therapyOccupational therapy for de Quervain's Tenosynovitis | Other | Occupational therapy |
| Occupational therapy with ASTYMOccupational therapy for de Quervain's Tenosynovitis plus ASTYM | Device | Occupational therapy with ASTYM |
Primary outcome
Numeric Rating Scale for Pain
Time frame: 4.5 months
This scale is a single point scale from 0-10. The participant picks one number to represent their pain, where 0 represents no pain and 10 represents worst pain imaginable.
2 secondary outcomes
Sequential Occupational Dexterity Assessment (SODA) Score
Time frame: 1.5 months
Quick Dash Score
Time frame: 4.5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for de Quervain's Disease
Enrolling by invitation
High and Low Level Laser Therapy in De Quervain's Tenosynovitis
DeQuervain Tendinopathy
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
RecruitingPhase 4
Ketorolac in Upper Extremity Tendinopathy and Arthropathy
Osteoarthritis, Tendinopathy
RecruitingPhase 4
Intra-sheath vs Extra-sheath Injection for De Quervain's Tenosynovitis
De Quervain Tenosynovitis
Recruiting
De Quervain's Disease in the Acute Phase:a Study Aimed at Evaluating the Effectiveness of Standard Physiotherapy Treatment (HANDGUIDE), Compared to Experimental Treatment After Performing Ultrasound-guided Infiltrative Therapy.
De Quervain Disease, Hand Tenosynovitis
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.
Stephen VanLew, PhD, OTR/L principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational therapy and Occupational therapy with ASTYM in people with de Quervain's Disease, run by NYU Langone Health 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 4 inclusion and 6 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 9 Oct 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2020). 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?
Numeric Rating Scale for Pain (time frame: 4.5 months). 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 9 Oct 2020.