A Pilot Randomized Controlled Trial for Hand Osteoarthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04784065
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Baylor College of Medicine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Grace H Lo, MD MSc
Principal Investigator Affiliation Baylor College of Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherNIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hand Osteoarthritis
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Treatment arm with control orthosis

Experimental: Treatment arm with experimental orthosis

Interventions

Device: - Hand orthosis

An orthosis applied to a hand affected by osteoarthritis with the expectation that it will improve symptoms and possibly structural progression.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Michael E. DeBakey VA Medical Center, Houston, Texas

Status

Recruiting

Address

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030

Site Contact

Michael Strayhorn, MPH

[email protected]

713-440-4646