de Quervain's Disease
Conditions
Keywords
de Quervain's disease, de Quervain's tenosynovitis., ASTYM, de Quervain's treatment
Brief 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. Two groups will be examined with one group receiving traditional therapy and the other group receiving traditional therapy in addition to Astym treatment protocol.
Interventions
OTHEROccupational therapy
Occupational therapy for de Quervain's Tenosynovitis
DEVICEOccupational therapy with ASTYM
Occupational therapy for de Quervain's Tenosynovitis plus ASTYM
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale for Pain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sequential Occupational Dexterity Assessment (SODA) Score | 1.5 months | 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. |
| Quick Dash Score | 4.5 months | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Occupational Therapy Traditional therapy for de Quervain's Tenosynovitis
Occupational therapy: Occupational therapy for de Quervain's Tenosynovitis | 15 |
| 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 | 17 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Occupational Therapy | Total | Occupational Therapy With ASTYM |
|---|---|---|---|
| Age, Continuous | 43.85 years STANDARD_DEVIATION 12.57 | 43.40 years STANDARD_DEVIATION 13.43 | 42.94 years STANDARD_DEVIATION 14.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 5 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants | 27 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 32 Participants | 17 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 15 participants | 32 participants | 17 participants |
| Sex: Female, Male Female | 13 Participants | 24 Participants | 11 Participants |
| Sex: Female, Male Male | 2 Participants | 8 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 17 |
| other Total, other adverse events | 0 / 15 | 0 / 17 |
| serious Total, serious adverse events | 0 / 15 | 0 / 17 |
Outcome results
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.
Time frame: 4.5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Occupational Therapy | Numeric Rating Scale for Pain | 3.2 score on a scale | Standard Deviation 2.5 |
| Occupational Therapy With ASTYM | Numeric Rating Scale for Pain | 2.1 score on a scale | Standard Deviation 2.7 |
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).
Time frame: 4.5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Occupational Therapy | Quick Dash Score | 4.72 score on a scale | Standard Deviation 5.6 |
| Occupational Therapy With ASTYM | Quick Dash Score | 10.61 score on a scale | Standard Deviation 12.05 |
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.
Time frame: 1.5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Occupational Therapy | Sequential Occupational Dexterity Assessment (SODA) Score | 107.33 score on a scale | Standard Deviation 5.6 |
| Occupational Therapy With ASTYM | Sequential Occupational Dexterity Assessment (SODA) Score | 106.75 score on a scale | Standard Deviation 6.1 |