An interventional study of Hand orthosis in Hand Osteoarthritis, sponsored by Baylor College of Medicine. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment
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.
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.
Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
An orthosis applied to a hand affected by osteoarthritis with the expectation that it will improve symptoms and possibly structural progression.
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
Time frame: 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
Time frame: 24 week follow up
The Functional Index for Hand Osteoarthritis (FIHOA)
An assessment of hand function. (high values are worse outcomes) Minumum score = 0 Maximum score = 30
Time frame: 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
Time frame: 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
Time frame: 24 week follow up
Grip Strength
An assessment of the amount of force that can be applied with grip. (low values are worse outcomes)
Time frame: 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)
Time frame: 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
Time frame: 24 week follow up
| Milestone | Treatment Arm With Control Orthosis | Treatment Arm With Experimental Orthosis |
|---|---|---|
| Started | 17 | 16 |
| Completed | 8 | 13 |
| Not completed | 9 | 3 |
An assessment of pain intensity in a given hand. - high values are worse outcomes. Minimum score = 0 Maximum score = 100
| units on a scale | Treatment Arm With Control Orthosis | Treatment Arm With Experimental Orthosis |
|---|---|---|
| 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 (-31.3 to -0.8) | -15.7 (-30.0 to -1.4) |
An assessment of radiographic OA severity. (high values are worse outcomes) Minimum score = 0 Maximum score = 16
| units on a scale | Treatment Arm With Control Orthosis | Treatment Arm With Experimental Orthosis |
|---|---|---|
| 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 | 0 ± 0 |
An assessment of hand function. (high values are worse outcomes) Minumum score = 0 Maximum score = 30
| units on a scale | Treatment Arm With Control Orthosis | Treatment Arm With Experimental Orthosis |
|---|---|---|
| The Functional Index for Hand Osteoarthritis (FIHOA) | 0.6 (-2.9 to 4.2) | -2.6 (-5.1 to -0.2) |
An assessment of hand disability. (high values are worse outcomes) Minimum score = 30 Maximum score = 150
| units on a scale | Treatment Arm With Control Orthosis | Treatment Arm With Experimental Orthosis |
|---|---|---|
| The Disabilities of Arm Shoulder and Hand (DASH) | 0.9 (-6.9 to 8.7) | -9.9 (-17.9 to -2.0) |
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
| seconds | Treatment Arm With Control Orthosis | Treatment Arm With Experimental Orthosis |
|---|---|---|
| Functional Dexterity Test | -3.8 (-11.8 to 4.3) | -6.4 (-11.0 to -1.9) |
An assessment of the amount of force that can be applied with grip. (low values are worse outcomes)
| pounds | Treatment Arm With Control Orthosis | Treatment Arm With Experimental Orthosis |
|---|---|---|
| Grip Strength | 3.1 (-0.5 to 6.7) | 5.3 (1.5 to 9.1) |
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)
| pounds | Treatment Arm With Control Orthosis | Treatment Arm With Experimental Orthosis |
|---|---|---|
| Pinch Strength | 0.4 (-1.3 to 2.0) | 0.2 (-0.8 to 1.3) |
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
| score on a scale | Treatment Arm With Control Orthosis | Treatment Arm With Experimental Orthosis |
|---|---|---|
| The Number of DIP Joints That Exhibit Tenderness in the Study Hand | -0.2 (-0.7 to 0.4) | -0.4 (-1.1 to 0.2) |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Arm With Control Orthosis | 0/17 (0%) | 0/17 (0%) | 8/17 (47.1%) |
| Treatment Arm With Experimental Orthosis | 0/16 (0%) | 0/16 (0%) | 8/16 (50%) |
| Event | Treatment Arm With Control Orthosis | Treatment Arm With Experimental Orthosis |
|---|---|---|
| Discomfort from the orthosisMusculoskeletal and connective tissue disorders | 5/17 | 7/16 |
| Numbness/TinglingNervous system disorders | 5/17 | 1/16 |
| Skin ErythemaSkin and subcutaneous tissue disorders | 0/17 | 1/16 |
| Skin blisteringSkin and subcutaneous tissue disorders | 0/17 | 1/16 |
| FallNervous system disorders | 0/17 | 1/16 |
| Elective surgery to repair incisional herniaEye disorders | 0/17 | 1/16 |
| Thoracic spine painMusculoskeletal and connective tissue disorders | 1/17 | 0/16 |
| Knee injuryMusculoskeletal and connective tissue disorders | 1/17 | 0/16 |
| Age, Continuous(Years) | Treatment Arm With Control Orthosis | Treatment Arm With Experimental Orthosis | Total |
|---|---|---|---|
| Mean | 66.5 ± 7.1 | 65.2 ± 6.6 | 65.8 ± 6.7 |
| Sex: Female, Male(Participants) | Treatment Arm With Control Orthosis | Treatment Arm With Experimental Orthosis | Total |
|---|---|---|---|
| Female | 10 | 6 | 16 |
| Male | 7 | 10 | 17 |
| Race (NIH/OMB)(Participants) | Treatment Arm With Control Orthosis | Treatment Arm With Experimental Orthosis | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 10 | 17 |
| White | 9 | 5 | 14 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Study Hand VAS(Units on a scale) | Treatment Arm With Control Orthosis | Treatment Arm With Experimental Orthosis | Total |
|---|---|---|---|
| Mean | 69.3 ± 18.9 | 59.4 ± 20.0 | 64.5 ± 19.8 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Icf
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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