Hand Osteoarthritis
Conditions
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.
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.
Interventions
DEVICEHand orthosis
An orthosis applied to a hand affected by osteoarthritis with the expectation that it will improve symptoms and possibly structural progression.
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. | 24 week follow up | An assessment of radiographic OA severity. (high values are worse outcomes) Minimum score = 0 Maximum score = 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Functional Index for Hand Osteoarthritis (FIHOA) | 24 week follow up | An assessment of hand function. (high values are worse outcomes) Minumum score = 0 Maximum score = 30 |
| The Disabilities of Arm Shoulder and Hand (DASH) | 24 week follow up | An assessment of hand disability. (high values are worse outcomes) Minimum score = 30 Maximum score = 150 |
| Functional Dexterity Test | 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 |
| Grip Strength | 24 week follow up | An assessment of the amount of force that can be applied with grip. (low values are worse outcomes) |
| Pinch Strength | 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) |
| The Number of DIP Joints That Exhibit Tenderness in the Study Hand | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm With Control Orthosis 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. | 17 |
| Treatment Arm With Experimental Orthosis 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. | 16 |
| Total | 33 |
Baseline characteristics
| Characteristic | Treatment Arm With Experimental Orthosis | Total | Treatment Arm With Control Orthosis |
|---|---|---|---|
| Age, Continuous | 65.2 Years STANDARD_DEVIATION 6.6 | 65.8 Years STANDARD_DEVIATION 6.7 | 66.5 Years STANDARD_DEVIATION 7.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 17 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 5 Participants | 14 Participants | 9 Participants |
| Sex: Female, Male Female | 6 Participants | 16 Participants | 10 Participants |
| Sex: Female, Male Male | 10 Participants | 17 Participants | 7 Participants |
| Study Hand VAS | 59.4 Units on a scale STANDARD_DEVIATION 20 | 64.5 Units on a scale STANDARD_DEVIATION 19.8 | 69.3 Units on a scale STANDARD_DEVIATION 18.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 16 |
| other Total, other adverse events | 8 / 17 | 8 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 |
Outcome results
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.
An assessment of radiographic OA severity. (high values are worse outcomes) Minimum score = 0 Maximum score = 16
Time frame: 24 week follow up
Population: Those participants at the Houston site who were randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm With Control 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 units on a scale | Standard Deviation 0 |
| 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 units on a scale | Standard Deviation 0 |
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.
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
Population: All randomized participants
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Arm With Control 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 units on a scale |
| 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. | -15.7 units on a scale |
Secondary
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
Population: All participants who were randomized.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Arm With Control Orthosis | Functional Dexterity Test | -3.8 seconds |
| Treatment Arm With Experimental Orthosis | Functional Dexterity Test | -6.4 seconds |
Secondary
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
Population: All randomized.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Arm With Control Orthosis | Grip Strength | 3.1 pounds |
| Treatment Arm With Experimental Orthosis | Grip Strength | 5.3 pounds |
Secondary
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
Population: All randomized.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Arm With Control Orthosis | Pinch Strength | 0.4 pounds |
| Treatment Arm With Experimental Orthosis | Pinch Strength | 0.2 pounds |
Secondary
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
Population: All those randomized.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Arm With Control Orthosis | The Disabilities of Arm Shoulder and Hand (DASH) | 0.9 units on a scale |
| Treatment Arm With Experimental Orthosis | The Disabilities of Arm Shoulder and Hand (DASH) | -9.9 units on a scale |
Secondary
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
Population: All those randomized.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Arm With Control Orthosis | The Functional Index for Hand Osteoarthritis (FIHOA) | 0.6 units on a scale |
| Treatment Arm With Experimental Orthosis | The Functional Index for Hand Osteoarthritis (FIHOA) | -2.6 units on a scale |
Secondary
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
Population: All randomized
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Arm With Control Orthosis | The Number of DIP Joints That Exhibit Tenderness in the Study Hand | -0.2 score on a scale |
| Treatment Arm With Experimental Orthosis | The Number of DIP Joints That Exhibit Tenderness in the Study Hand | -0.4 score on a scale |