A Pilot Randomized Controlled Trial for Hand Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Hand Osteoarthritis
• Intervention / Treatment: Device: Hand orthosis

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone
  • Texas
    • Houston, Texas, United States, 77030
      • Michael E. DeBakey VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Hand orthosis; An orthosis applied to a hand affected by osteoarthritis with the expectation that it will improve symptoms and possibly structural progression.
Experimental: 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.	Device: Hand orthosis; An orthosis applied to a hand affected by osteoarthritis with the expectation that it will improve symptoms and possibly structural progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. - high values are worse outcomes. Minimum score = 0 Maximum score = 100	24 week follow up
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. (high values are worse outcomes) Minimum score = 0 Maximum score = 16	24 week follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Functional Index for Hand Osteoarthritis (FIHOA)	An assessment of hand function. (high values are worse outcomes) Minumum score = 0 Maximum score = 30	24 week follow up
The Disabilities of Arm Shoulder and Hand (DASH)	An assessment of hand disability. (high values are worse outcomes) Minimum score = 30 Maximum score = 150	24 week follow up
Functional Dexterity Test	An assessment of hand functional dexterity. (high values are worse outcomes) Measure of the number of seconds it takes for the participant to complete a series of activities. Penalty scores are assigned if the quality of the activity performed is imperfect. Minimum score = 0 Maximum score = indefinite	24 week follow up
Grip Strength	An assessment of the amount of force that can be applied with grip. (low values are worse outcomes)	24 week follow up
Pinch Strength	An assessment of the amount of force that can be applied with pinching between thumb and the 2nd and 3rd fingers. (low values are worse outcomes)	24 week follow up
The Number of DIP Joints That Exhibit Tenderness in the Study Hand	The number of DIP joints that exhibit tenderness (dichotomously assessed - yes/no) in the study hand. (high values are worse outcomes) Minimum score = 0 Maximum score = 4	24 week follow up

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Grace H Lo, MD MSc, Baylor College of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2021
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 9, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: H44508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from this study may be requested from other researchers 3 years after the completion of the primary endpoint by contacting Dr. Grace Lo.
• IPD Sharing Time Frame: 3 years after the completion of the primary endpoint
• IPD Sharing Access Criteria: To be determined on a case by case basis.
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No