Hand OsteoarthritisNCT04784065
A Pilot Randomized Controlled Trial for Hand Osteoarthritis
A study testing Hand orthosis in people with Hand Osteoarthritis, run by Baylor College of Medicine at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- Hand orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Feb 2021to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
NYU Langone
New York, New York, 10016
About this study
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.
Read the 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
- Being tested
- Hand orthosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand orthosisDevice
An orthosis applied to a hand affected by osteoarthritis with the expectation that it will improve symptoms and possibly structural progression.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Hand orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 24 week follow up
Secondary outcomes (6)
The Functional Index for Hand Osteoarthritis (FIHOA)
An assessment of hand function. (high values are worse outcomes) Minumum score = 0 Maximum score = 30
Measured: 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
Measured: 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
Measured: 24 week follow up
Grip Strength
An assessment of the amount of force that can be applied with grip. (low values are worse outcomes)
Measured: 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)
Measured: 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
Measured: 24 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start11 Feb 2021
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Grace Hsiao-Wei Lo, Baylor College of Medicine
- Investigators
- Grace H Lo, MD MSc, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784065
- Sponsor's protocol ID
- H44508
- Status last verified
- Aug 2025
- First submitted
- 3 Mar 2021
- Last updated
- 28 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data from this study may be requested from other researchers 3 years after the completion of the primary endpoint by contacting Dr. Grace Lo.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial for Hand Osteoarthritis
- ClinicalTrials.gov ID
- NCT04784065
- Acronym / sponsor ID
- H44508
- Conditions
- Hand Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Posted 28 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm with control orthosis | Active comparator | Device: Hand orthosisA 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. |
| Treatment arm with experimental orthosis | Experimental | Device: Hand orthosisAn 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand orthosisAn orthosis applied to a hand affected by osteoarthritis with the expectation that it will improve symptoms and possibly structural progression. | Device | Treatment arm with control orthosis, Treatment arm with experimental orthosis |
Primary outcome
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
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
6 secondary outcomes
The Functional Index for Hand Osteoarthritis (FIHOA)
Time frame: 24 week follow up
The Disabilities of Arm Shoulder and Hand (DASH)
Time frame: 24 week follow up
Functional Dexterity Test
Time frame: 24 week follow up
Grip Strength
Time frame: 24 week follow up
Pinch Strength
Time frame: 24 week follow up
The Number of DIP Joints That Exhibit Tenderness in the Study Hand
Time frame: 24 week follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Presented at the American College of Rheumatology Convergence Meeting, Nov 2024.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data from this study may be requested from other researchers 3 years after the completion of the primary endpoint by contacting Dr. Grace Lo.
Related trials for Hand Osteoarthritis
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Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments
Erosive Hand Osteoarthritis
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Acupuncture vs Sham Acupuncture for Hand Osteoarthritis
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Not yet recruitingPhase 2
Topical Clobetasol Propionate for Inflammatory Hand Osteoarthritis
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Recruiting
High-Energy Laser in the Conservative Treatment of Rhizarthrosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace H Lo, MD MSc principal investigator
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand orthosis in people with Hand Osteoarthritis, run by Baylor College of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025; AzTrials last refreshed its copy on 28 Oct 2026.