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A Pilot Randomized Controlled Trial for Hand Osteoarthritis

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ClinicalTrials.gov Identifier: NCT04784065
Recruitment Status : Recruiting
First Posted : March 5, 2021
Last Update Posted : March 5, 2021
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Grace Hsiao-Wei Lo, Baylor College of Medicine

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.

Condition or disease Intervention/treatment Phase
Hand Osteoarthritis Device: Hand orthosis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: A Pilot Randomized Controlled Trial for Hand Osteoarthritis
Actual Study Start Date : February 11, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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




Primary Outcome Measures :
  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.

  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.


Secondary Outcome Measures :
  1. The Functional Index for Hand Osteoarthritis (FIHOA) [ Time Frame: 24 week follow up ]
    An assessment of hand function

  2. The Disabilities of Arm Shoulder and Hand (DASH) [ Time Frame: 24 week follow up ]
    An assessment of hand disability

  3. Functional Dexterity Test [ Time Frame: 24 week follow up ]
    An assessment of hand functional dexterity

  4. Grip Strength [ Time Frame: 24 week follow up ]
    An assessment of the amount of force that can be applied with grip

  5. PinchStrength [ 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.

  6. Tenderness on joint palpation [ Time Frame: 24 week follow up ]
    An assessment of the amount of tenderness the participant has with palpation of the joints of interest.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04784065


Contacts
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Contact: Grace H Lo, MD MSc 713-791-1414 ext 27804 ghlo@bcm.edu

Locations
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United States, Texas
Michael E. DeBakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Michael Strayhorn, MPH    713-440-4646    Michael.Strayhorn@va.gov   
Principal Investigator: Grace H Lo, MD MSc         
Sponsors and Collaborators
Baylor College of Medicine
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Grace H Lo, MD MSc Baylor College of Medicine
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Responsible Party: Grace Hsiao-Wei Lo, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT04784065    
Other Study ID Numbers: H44508
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Informed Consent Form (ICF)
Time Frame: 3 years after the completion of the primary endpoint
Access Criteria: To be determined on a case by case basis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases