A Pilot Randomized Controlled Trial for Hand Osteoarthritis

NCT04784065 | Completed Results FDA Device

• 1 other identifier: H44508
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Hand Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• The Functional Index for Hand Osteoarthritis (FIHOA)

  24 week follow up

• The Disabilities of Arm Shoulder and Hand (DASH)

  24 week follow up

• Functional Dexterity Test

  24 week follow up

• Grip Strength

  24 week follow up

• Pinch Strength

  24 week follow up

Study Arms (2)

Treatment arm with control orthosis

ACTIVE COMPARATOR

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

Treatment arm with experimental orthosis

EXPERIMENTAL

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

Interventions

Hand orthosis 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 control orthosis; Treatment arm with experimental orthosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (2)

NYU Langone

New York, New York, 10016, United States

Location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

Related Links

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

Results Point of Contact

• Title: Dr. Grace Lo, Associate Professor of Medicine
• Organization: Baylor College of Medicine

ghlo@bcm.edu

713-791-1414

Study Officials

• Grace H Lo, MD MSc

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The occupational therapists fabricating the orthoses used the study are the only ones not blinded in this study. The participants, principal investigator, and research assistants are all blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 5, 2021
• Study Start: February 11, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: August 28, 2025
• Results First Posted: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: 3 years after the completion of the primary endpoint
• Access Criteria: To be determined on a case by case basis.

Locations

US (2)