A Pilot Randomized Controlled Trial for Hand Osteoarthritis

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Enrolled to receive medical care at the Michael E. DeBakey VA Medical Center
At least 3 joints affected by distal interphalangeal (DIP) nodal hand OA
DIP nodal hand OA will be defined as Heberden's nodes on physical exam.
Sufficiently severe frequent pain of at least one DIP
Frequent pain: pain on most days of the month for at least one month in the last year.
Minimum VAS pain severity of 40 on a 0 - 100 scale

Exclusion Criteria

History or current inflammatory arthritides (examples: gout, psoriatic arthritis, and rheumatoid arthritis)
Prior surgery on the DIP joints
Planned surgery for the DIP joints
Pregnancy

Primary Outcome Measures

Name	Time	Method
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.	24 week follow up	An assessment of pain intensity in a given hand. - high values are worse outcomes. Minimum score = 0 Maximum score = 100
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.	24 week follow up	An assessment of radiographic OA severity. (high values are worse outcomes) Minimum score = 0 Maximum score = 16

Secondary Outcome Measures

Name	Time	Method
The Functional Index for Hand Osteoarthritis (FIHOA)	24 week follow up	An assessment of hand function. (high values are worse outcomes) Minumum score = 0 Maximum score = 30
The Disabilities of Arm Shoulder and Hand (DASH)	24 week follow up	An assessment of hand disability. (high values are worse outcomes) Minimum score = 30 Maximum score = 150
Functional Dexterity Test	24 week follow up	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
Grip Strength	24 week follow up	An assessment of the amount of force that can be applied with grip. (low values are worse outcomes)
Pinch Strength	24 week follow up	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)
The Number of DIP Joints That Exhibit Tenderness in the Study Hand	24 week follow up	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

Locations (2): NYU Langone
🇺🇸
New York, New York, United States
Michael E. DeBakey VA Medical Center
🇺🇸
Houston, Texas, United States
NYU Langone
🇺🇸New York, New York, United States