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NCT Number: NCT04784065

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.

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Key information

Conditions

Hand Osteoarthritis

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hand orthosis

Device

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

Primary outcomes

  1. 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.

    Time frame: 24 week follow up

    An assessment of pain intensity in a given hand. - high values are worse outcomes.

    Minimum score = 0 Maximum score = 100

  2. 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.

    Time frame: 24 week follow up

    An assessment of radiographic OA severity. (high values are worse outcomes) Minimum score = 0 Maximum score = 16

Secondary outcomes

  1. The Functional Index for Hand Osteoarthritis (FIHOA)

    Time frame: 24 week follow up

    An assessment of hand function. (high values are worse outcomes) Minumum score = 0 Maximum score = 30

  2. The Disabilities of Arm Shoulder and Hand (DASH)

    Time frame: 24 week follow up

    An assessment of hand disability. (high values are worse outcomes) Minimum score = 30 Maximum score = 150

  3. Functional Dexterity Test

    Time frame: 24 week follow up

    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

  4. Grip Strength

    Time frame: 24 week follow up

    An assessment of the amount of force that can be applied with grip. (low values are worse outcomes)

  5. Pinch Strength

    Time frame: 24 week follow up

    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)

  6. The Number of DIP Joints That Exhibit Tenderness in the Study Hand

    Time frame: 24 week follow up

    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

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

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

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 5, 2021
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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