Effectiveness of Astym Treatment For de Quervain's Tenosynovitis

Not Applicable

Completed

• Conditions: de Quervain's Disease
• Interventions: Device: Occupational therapy with ASTYM; Other: Occupational therapy

• Registration Number: NCT02442622
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-05-08
• Study First Submitted QC: 2015-05-12
• Study First Posted: 2015-05-13
• Primary Completion: 2019-04-29
• Study Completion: 2019-04-29
• Results First Submitted: 2020-08-25
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-16
• Last Update Submitted: 2020-09-16
• Results First Posted: 2020-10-09
• Last Update Posted: 2020-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Occupational therapy with ASTYM	Occupational therapy with ASTYM	Traditional therapy for de Quervain's Tenosynovitis plus ASTYM
Occupational therapy	Occupational therapy	Traditional therapy for de Quervain's Tenosynovitis

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

NYU Langone Medical Center, Center for Musculoskeletal Care; 🇺🇸 New York, New York, United States