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Factors Associated With Radiographic Pathophysiology for Trapeziometacarpal Arthrosis in Patients Not Seeking Care for This Condition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02252939
Recruitment Status : Completed
First Posted : September 30, 2014
Results First Posted : November 6, 2017
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Neal Chung-Jen Chen, Massachusetts General Hospital

Study Description
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Brief Summary:
The investigators are doing this research study to discover factors, such as job, hobbies, or race that are associated with arthrosis at the base of your thumb on X-rays. Thumb arthrosis is one of the most common kinds of arthritis. About 116 people will take part in this research study at Massachusetts General Hospital (MGH).

Condition or disease Intervention/treatment Phase
Trapeziometacarpal Arthrosis Radiation: X-Ray Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Factors Associated With Radiographic Pathophysiology for Trapeziometacarpal Arthrosis in Patients Not Seeking Care for This Condition
Study Start Date : September 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with Trapeziometacarpal (TMC) Arthrosis
Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis
 Radiation: X-Ray
X-ray as part of standard care


Outcome Measures
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Primary Outcome Measures :
  1. Factors Associated With Eaton Classification of Trapeziometacarpal Arthrosis: Age [ Time Frame: Baseline at Day 1 ]
    Radiographs were scored using the Eaton score range.The Eaton score ranges from 1-4 where 1 is the least severe and 4 is the most severe for arthritis. Patients without TMC Arthritis would have a score of 0. Patients' age measured in years.


Secondary Outcome Measures :
  1. Factors Associated With Thumb Pain: Hyperextension of Metacarpophalangeal Joint [ Time Frame: Day 1, baseline ]
    Thumb pain measured on a scale of 0-10 and dichotomized by having thumb pain (yes/no), hyperextension dichotomized (yes/no)

  2. QuickDASH (Disability of the Arm, Shoulder, and Hand) [ Time Frame: Day 1, baseline ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 55 years and older
  • Not seeking care for TMC arthrosis from hand surgeon at the time of visit
  • english fluency and literacy

Exclusion Criteria:

-

Contacts and Locations
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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): NCT02252939


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Neal Chen, MD Massachusetts General Hospital
More Information
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Publications:
DeGood DE, Tait RC. Assessment of pain beliefs and pain coping. In: Turk DC, Melzack R (Eds.) Handbook of pain assessment, 2nd ed. New York, Guilford Press, 2001: 320-45.

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Responsible Party: Neal Chung-Jen Chen, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02252939    
Other Study ID Numbers: 2013P000827
First Posted: September 30, 2014    Key Record Dates
Results First Posted: November 6, 2017
Last Update Posted: August 14, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Osteoarthritis
Joint Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases