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Completed

NCT Number: NCT02442622

Effectiveness of Astym Treatment For de Quervain's Tenosynovitis

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.

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Key information

Conditions

de Quervain's Disease De Quervain Disease Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Entrapment

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Medical Center, Center for Musculoskeletal Care

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Occupational Therapy

Other

Occupational therapy for de Quervain's Tenosynovitis

Occupational therapy with ASTYM

Device

Occupational therapy for de Quervain's Tenosynovitis plus ASTYM

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 13, 2015
Registry last updated
Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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