Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Occupational therapy | Active Comparator | Traditional therapy for de Quervain's Tenosynovitis |
|
| Occupational therapy with ASTYM | Experimental | Traditional therapy for de Quervain's Tenosynovitis plus ASTYM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occupational therapy | Other | Occupational therapy for de Quervain's Tenosynovitis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1.5 months |
Not provided
Inclusion Criteria:
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 steroid 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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephen VanLew, PhD, OTR/L | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Medical Center, Center for Musculoskeletal Care | New York | New York | 10016 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Occupational Therapy | Traditional therapy for de Quervain's Tenosynovitis Occupational therapy: Occupational therapy for de Quervain's Tenosynovitis |
| FG001 | Occupational Therapy With ASTYM | Traditional therapy for de Quervain's Tenosynovitis plus ASTYM Occupational therapy with ASTYM: Occupational therapy for de Quervain's Tenosynovitis plus ASTYM |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Occupational Therapy | Traditional therapy for de Quervain's Tenosynovitis Occupational therapy: Occupational therapy for de Quervain's Tenosynovitis |
| BG001 | Occupational Therapy With ASTYM |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 4.5 months |
|
up to 4.5 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Occupational Therapy | Traditional therapy for de Quervain's Tenosynovitis Occupational therapy: Occupational therapy for de Quervain's Tenosynovitis |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steve Vanlew, PhD | NYU Langone Health | 646-501-7707 | Steve.Vanlew@nyulangone.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2015 | Aug 25, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D053684 | De Quervain Disease |
| ID | Term |
|---|---|
| D053682 | Tendon Entrapment |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Occupational therapy with ASTYM |
| Device |
Occupational therapy for de Quervain's Tenosynovitis plus ASTYM |
|
| 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). | 4.5 months |
Traditional therapy for de Quervain's Tenosynovitis plus ASTYM
Occupational therapy with ASTYM: Occupational therapy for de Quervain's Tenosynovitis plus ASTYM
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 1.5 months |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | 4.5 months |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Occupational Therapy With ASTYM | Traditional therapy for de Quervain's Tenosynovitis plus ASTYM Occupational therapy with ASTYM: Occupational therapy for de Quervain's Tenosynovitis plus ASTYM | 0 | 17 | 0 | 17 | 0 | 17 |
Not provided
Not provided
Not provided
| D013812 |
| Therapeutics |