N/A
N=33
A Pilot Randomized Controlled Trial for Hand Osteoarthritis
Hand Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT04784065 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: 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. — -16.1; -15.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hand orthosis (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
-16.1; -15.7 | — |
| PRIMARY 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. |
0; 0 | — |
| SECONDARY The Functional Index for Hand Osteoarthritis (FIHOA) |
0.6; -2.6 | — |
| SECONDARY The Disabilities of Arm Shoulder and Hand (DASH) |
0.9; -9.9 | — |
| SECONDARY Functional Dexterity Test |
-3.8; -6.4 | — |
| SECONDARY Grip Strength |
3.1; 5.3 | — |
| SECONDARY Pinch Strength |
0.4; 0.2 | — |
| SECONDARY The Number of DIP Joints That Exhibit Tenderness in the Study Hand |
-0.2; -0.4 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04784065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.