Back to resultsEffectiveness of Astym Treatment For de Quervain's Tenosynovitis
Primary Purpose
de Quervain's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Occupational therapy
Occupational therapy with ASTYM
Sponsored by
About this trial
This is an interventional treatment trial for de Quervain's Disease focused on measuring de Quervain's disease, de Quervain's tenosynovitis., ASTYM, de Quervain's treatment
Eligibility Criteria
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
Sites / Locations
- NYU Langone Medical Center, Center for Musculoskeletal Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Occupational therapy
Occupational therapy with ASTYM
Arm Description
Traditional therapy for de Quervain's Tenosynovitis
Traditional therapy for de Quervain's Tenosynovitis plus ASTYM
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02442622
Brief Title
Effectiveness of Astym Treatment For de Quervain's Tenosynovitis
Official Title
Effectiveness of Astym Treatment For de Quervain's Tenosynovitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
April 29, 2019 (Actual)
Study Completion Date
April 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
de Quervain's Disease
Keywords
de Quervain's disease, de Quervain's tenosynovitis., ASTYM, de Quervain's treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Occupational therapy
Arm Type
Active Comparator
Arm Description
Traditional therapy for de Quervain's Tenosynovitis
Arm Title
Occupational therapy with ASTYM
Arm Type
Experimental
Arm Description
Traditional therapy for de Quervain's Tenosynovitis plus ASTYM
Intervention Type
Other
Intervention Name(s)
Occupational therapy
Intervention Description
Occupational therapy for de Quervain's Tenosynovitis
Intervention Type
Device
Intervention Name(s)
Occupational therapy with ASTYM
Intervention Description
Occupational therapy for de Quervain's Tenosynovitis plus ASTYM
Primary Outcome Measure Information:
Title
Numeric Rating Scale for Pain
Description
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
Secondary Outcome Measure Information:
Title
Sequential Occupational Dexterity Assessment (SODA) Score
Description
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
Title
Quick Dash Score
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen VanLew, PhD, OTR/L
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Medical Center, Center for Musculoskeletal Care
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
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Effectiveness of Astym Treatment For de Quervain's Tenosynovitis
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