A Pilot Randomized Controlled Trial for Hand Osteoarthritis

Hand Osteoarthritis Clinical Trial

Official title:

A Pilot Randomized Controlled Trial for Hand Osteoarthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04784065
• Other study ID #: H44508
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 11, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hand Osteoarthritis
• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center	Houston	Texas
United States	NYU Langone	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The Functional Index for Hand Osteoarthritis (FIHOA)	An assessment of hand function	24 week follow up
Secondary	The Disabilities of Arm Shoulder and Hand (DASH)	An assessment of hand disability	24 week follow up
Secondary	Functional Dexterity Test	An assessment of hand functional dexterity	24 week follow up
Secondary	Grip Strength	An assessment of the amount of force that can be applied with grip	24 week follow up
Secondary	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
Secondary	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