Clinical trial NCT04784065: A Pilot Randomized Controlled Trial for Hand Osteoarthritis
Official title: A Pilot Randomized Controlled Trial for Hand Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Osteoarthritis
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2021-03-05
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 24 week follow up
measure: 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.
timeFrame: 24 week follow up
Secondary outcomes:
measure: The Functional Index for Hand Osteoarthritis (FIHOA)
timeFrame: 24 week follow up
measure: The Disabilities of Arm Shoulder and Hand (DASH)
timeFrame: 24 week follow up
measure: Functional Dexterity Test
timeFrame: 24 week follow up
measure: Grip Strength
timeFrame: 24 week follow up
measure: PinchStrength
timeFrame: 24 week follow up
measure: Tenderness on joint palpation
timeFrame: 24 week follow up
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone
state: New York
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Grace H Lo, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: