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Effectiveness of Astym Treatment For de Quervain's Tenosynovitis

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ClinicalTrials.gov Identifier: NCT02442622
Recruitment Status : Completed
First Posted : May 13, 2015
Results First Posted : October 9, 2020
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
de Quervain's Disease Other: Occupational therapy Device: Occupational therapy with ASTYM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Astym Treatment For de Quervain's Tenosynovitis
Actual Study Start Date : January 2015
Actual Primary Completion Date : April 29, 2019
Actual Study Completion Date : April 29, 2019

Arm Intervention/treatment
Active Comparator: Occupational therapy
Traditional therapy for de Quervain's Tenosynovitis
Other: Occupational therapy
Occupational therapy for de Quervain's Tenosynovitis

Experimental: Occupational therapy with ASTYM
Traditional therapy for de Quervain's Tenosynovitis plus ASTYM
Device: Occupational therapy with ASTYM
Occupational therapy for de Quervain's Tenosynovitis plus ASTYM




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Sequential Occupational Dexterity Assessment (SODA) Score [ Time Frame: 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.

  2. Quick Dash Score [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442622


Locations
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United States, New York
NYU Langone Medical Center, Center for Musculoskeletal Care
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Stephen VanLew, PhD, OTR/L NYU Langone Medical Center
  Study Documents (Full-Text)

Documents provided by NYU Langone Health:
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02442622    
Other Study ID Numbers: 14-01059
First Posted: May 13, 2015    Key Record Dates
Results First Posted: October 9, 2020
Last Update Posted: October 9, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by NYU Langone Health:
de Quervain's disease
de Quervain's tenosynovitis.
ASTYM
de Quervain's treatment
Additional relevant MeSH terms:
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Tenosynovitis
De Quervain Disease
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Entrapment