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Effectiveness of Astym Treatment For de Quervain's Tenosynovitis

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ClinicalTrials.gov Identifier: NCT02442622
Recruitment Status : Recruiting
First Posted : May 13, 2015
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

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

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 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 [ Time Frame: 1.5 months ]
  2. Quick Dash [ Time Frame: 4.5 months ]


Information from the National Library of Medicine

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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


Contacts
Contact: April O'Connell, OTR/L, CHT (646) 501-7077 April.Davis@nyumc.org

Locations
United States, New York
NYU Langone Medical Center, Center for Musculoskeletal Care Recruiting
New York, New York, United States, 10016
Contact: April O'Connell, OTR/L,CHT    646-501-7707    April.Davis@nyumc.org   
Contact: Daniel Geller, MS,MPH,OTR/L    646-501-7753    daniel.geller@nyumc.org   
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Stephen VanLew, MS, OTR/L NYU Langone Medical Center

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02442622     History of Changes
Other Study ID Numbers: 14-01059
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by New York University School of Medicine:
de Quervain's disease
de Quervain's tenosynovitis.
ASTYM
de Quervain's treatment

Additional relevant MeSH terms:
Tenosynovitis
De Quervain Disease
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Entrapment