This is a study involving people receiving care at the Michael E. DeBakey VA Medical Center, Houston Texas. We are studying people who have hand osteoarthritis (the most common form of arthritis that involves the hand) and testing treatments for the condition with the hope that we can help to improve hand pain as well as limit the damage that occurs related to the arthritis. People who choose to participate, are randomly assigned to one of two treatments, both expected to be helpful.
The research will be conducted at the following location(s): Baylor College of Medicine, Baylor St. Luke's Medical Center (BSLMC), and Michael E. DeBakey Veterans Affairs Medical Center. Participants of this study are consented for the study, randomized into one of two treatment groups for hand osteoarthritis, both expected to improve hand symptoms. At the beginning of the study, many questionnaires, a physical exam, photographs of the hands, some x-rays, on a limited few people, and MRI will be obtained. Then the participants will be provided treatments for hand osteoarthritis based on the group wo which they were randomly assigned. One aspect of one of the treatments is viewed as experimental but the risks related to the treatment are considered to be low, so the risk-benefit ratio for participation in this study are good. We see patients in follow up more frequently during the first month, and then at 3 months and then 6 months of follow up. At the final visit, we will repeat the xrays and the MRIs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
33
An orthosis applied to a hand affected by osteoarthritis with the expectation that it will improve symptoms and possibly structural progression.
NYU Langone
New York, New York, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, United States
Visual Analog Scale (VAS) for Pain in the More Symptomatic Hand That Includes the Most Symptomatic DIP Joint by 24 Weeks of Use of Traction Therapy With Standard of Care Treatment for Hand OA to Establish Efficacy of Traction Therapy.
An assessment of pain intensity in a given hand. - high values are worse outcomes. Minimum score = 0 Maximum score = 100
Time frame: 24 week follow up
The Primary Structure Endpoint Will be Change in Sum of the Kellgren and Lawrence Score of All Distal InterPhalangeal Joints in the Hand That Was Placed in an Orthosis Over 24 Weeks.
An assessment of radiographic OA severity. (high values are worse outcomes) Minimum score = 0 Maximum score = 16
Time frame: 24 week follow up
The Functional Index for Hand Osteoarthritis (FIHOA)
An assessment of hand function. (high values are worse outcomes) Minumum score = 0 Maximum score = 30
Time frame: 24 week follow up
The Disabilities of Arm Shoulder and Hand (DASH)
An assessment of hand disability. (high values are worse outcomes) Minimum score = 30 Maximum score = 150
Time frame: 24 week follow up
Functional Dexterity Test
An assessment of hand functional dexterity. (high values are worse outcomes) Measure of the number of seconds it takes for the participant to complete a series of activities. Penalty scores are assigned if the quality of the activity performed is imperfect. Minimum score = 0 Maximum score = indefinite
Time frame: 24 week follow up
Grip Strength
An assessment of the amount of force that can be applied with grip. (low values are worse outcomes)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 24 week follow up
Pinch Strength
An assessment of the amount of force that can be applied with pinching between thumb and the 2nd and 3rd fingers. (low values are worse outcomes)
Time frame: 24 week follow up
The Number of DIP Joints That Exhibit Tenderness in the Study Hand
The number of DIP joints that exhibit tenderness (dichotomously assessed - yes/no) in the study hand. (high values are worse outcomes) Minimum score = 0 Maximum score = 4
Time frame: 24 week follow up