A Pilot Randomized Controlled Trial for Hand Osteoarthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Randomized Controlled Trial for Hand Osteoarthritis

Conditions
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Hand Osteoarthritis

Intervention / Treatment
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* Device: Hand orthosis


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment arm with control orthosis<br> | Device: Hand orthosis<br>* An orthosis applied to a hand affected by osteoarthritis with the expectation that it will improve symptoms and possibly structural progression.<br>|
| Experimental: Treatment arm with experimental orthosis<br> | Device: Hand orthosis<br>* An orthosis applied to a hand affected by osteoarthritis with the expectation that it will improve symptoms and possibly structural progression.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 24 week follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Functional Index for Hand Osteoarthritis (FIHOA) | An assessment of hand function | 24 week follow up | 
| The Disabilities of Arm Shoulder and Hand (DASH) | An assessment of hand disability | 24 week follow up | 
| Functional Dexterity Test | An assessment of hand functional dexterity | 24 week follow up | 
| Grip Strength | An assessment of the amount of force that can be applied with grip | 24 week follow up | 
| PinchStrength | An assessment of the amount of force that can be applied with pinching between thumb and the 2nd and 3rd fingers. | 24 week follow up | 
| Tenderness on joint palpation | An assessment of the amount of tenderness the participant has with palpation of the joints of interest. | 24 week follow up |