A Pilot Randomized Controlled Trial for Hand Osteoarthritis

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    100
  • sponsor
    Baylor College of Medicine
Updated on 12 March 2021

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.

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.

Details
Condition Hand Osteoarthritis
Treatment Hand orthosis
Clinical Study IdentifierNCT04784065
SponsorBaylor College of Medicine
Last Modified on12 March 2021

Eligibility

Yes No Not Sure

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
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How to participate?

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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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