An interventional study of Occupational therapy and Occupational therapy with ASTYM in de Quervain's Disease, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-10-09.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
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.
30 studies on the registry are indexed under De Quervain Disease; 7 are open to participants now.
This study's enrollment of 32 is below the median of 55 across 26 interventional studies indexed under De Quervain Disease.
Browse De Quervain Disease studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
i. 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.
ii. Persistent symptoms for >3 wks which have not resolved after an additional 3 weeks of splinting
iii. A diagnosis by a physician of "de Quervain's", "fist compartment tenosynovitis", or "radial styloid tenosynovitis"
iv. Patients must agree and comply to a predetermined splinting regimen
Exclusion Criteria:
i. History of cortical injection to affected wrist and/or thumb
ii. History of previous wrist trauma to affected limb
iii. Comorbidity such as carpal tunnel syndrome (CTS), radial tunnel syndrome, osteoarthritis, rheumatoid arthritis, auto-immune disease or inflammatory conditions, lateral epicondylitis or tendinopathies
iv. Clotting deficits
v. Positive Cozen's sign which would indicate intersection syndrome
vi. Post-partum mothers \<6 months and pregnant women
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Traditional therapy for de Quervain's Tenosynovitis
Other: Occupational therapy
Traditional therapy for de Quervain's Tenosynovitis plus ASTYM
Device: Occupational therapy with ASTYM
Occupational therapy for de Quervain's Tenosynovitis
Occupational therapy for de Quervain's Tenosynovitis plus ASTYM
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.
Time frame: 4.5 months
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.
Time frame: 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).
Time frame: 4.5 months
| Milestone | Occupational Therapy | Occupational Therapy With ASTYM |
|---|---|---|
| Started | 15 | 17 |
| Completed | 12 | 16 |
| Not completed | 3 | 1 |
| Withdrew: Withdrawal by subject | 3 | 1 |
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.
| score on a scale | Occupational Therapy | Occupational Therapy With ASTYM |
|---|---|---|
| Numeric Rating Scale for Pain | 3.2 ± 2.5 | 2.1 ± 2.7 |
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.
| score on a scale | Occupational Therapy | Occupational Therapy With ASTYM |
|---|---|---|
| Sequential Occupational Dexterity Assessment (SODA) Score | 107.33 ± 5.6 | 106.75 ± 6.1 |
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).
| score on a scale | Occupational Therapy | Occupational Therapy With ASTYM |
|---|---|---|
| Quick Dash Score | 4.72 ± 5.60 | 10.61 ± 12.05 |
Collected over up to 4.5 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Occupational Therapy | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Occupational Therapy With ASTYM | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Continuous(years) | Occupational Therapy | Occupational Therapy With ASTYM | Total |
|---|---|---|---|
| Mean | 43.85 ± 12.57 | 42.94 ± 14.28 | 43.40 ± 13.43 |
| Sex: Female, Male(Participants) | Occupational Therapy | Occupational Therapy With ASTYM | Total |
|---|---|---|---|
| Female | 13 | 11 | 24 |
| Male | 2 | 6 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Occupational Therapy | Occupational Therapy With ASTYM | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 5 | 5 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 15 | 12 | 27 |
| Race (NIH/OMB)(Participants) | Occupational Therapy | Occupational Therapy With ASTYM | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 15 | 17 | 32 |
| Region of Enrollment(participants) | Occupational Therapy | Occupational Therapy With ASTYM | Total |
|---|---|---|---|
| United States | 15 | 17 | 32 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2015 to primary completion in Apr 2019, 51 months.
Results were first posted in Oct 2020, 1 year 5 months after primary completion.
Of 16 interventional studies with no phase under De Quervain Disease, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 28. This study's 51 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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