A Pilot Randomized Controlled Trial for Hand Osteoarthritis

NCT ID: NCT04784065

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-11
• Study Completion Date: 2024-04-01

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.

Conditions

Hand Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment arm with control orthosis

A resting orthosis that was modified to allow for convenient application of finger traps. A finger trap was customized to the most symptomatic DIP and any other digit that the participant requested.

The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.

Group Type: ACTIVE_COMPARATOR

Hand orthosis

Intervention Type: DEVICE

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

Treatment arm with experimental orthosis

An identical resting hand orthosis to what the traction arm received without the finger trap modifications.

The participants were asked to continue the orthosis schedule for the full 24 weeks of the study. Besides the resting hand orthosis, the SOC treatment included a thermal modality, activity modification/ joint protection education, and range of motion exercises.

Group Type: EXPERIMENTAL

Hand orthosis

Intervention Type: DEVICE

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

Interventions

Hand orthosis

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

Intervention Type: DEVICE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Grace Hsiao-Wei Lo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grace H Lo, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

NYU Langone

New York, New York, United States

Michael E. DeBakey VA Medical Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://acrabstracts.org/abstract/a-pilot-randomized-controlled-trial-for-hand-osteoarthritis/

Presented at the American College of Rheumatology Convergence Meeting, Nov 2024.

Other Identifiers

H44508

Identifier Type: -

Identifier Source: org_study_id