A Pilot Randomized Controlled Trial for Hand Osteoarthritis

Baylor College of Medicine

Status

Completed

Conditions

Hand Osteoarthritis

Treatments

Device: Hand orthosis

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04784065

H44508

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

All

Volunteers

No Healthy Volunteers

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