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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hand orthosis | Device | An orthosis applied to a hand affected by osteoarthritis with the expectation that it will improve symptoms and possibly structural progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 24 week follow up |
| Measure | Description | Time Frame |
|---|---|---|
| The Functional Index for Hand Osteoarthritis (FIHOA) | An assessment of hand function. (high values are worse outcomes) Minumum score = 0 Maximum score = 30 | 24 week follow up |
| The Disabilities of Arm Shoulder and Hand (DASH) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grace H Lo, MD MSc | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone | New York | New York | 10016 | United States | ||
| Michael E. DeBakey VA Medical Center |
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| Label | URL |
|---|---|
| Presented at the American College of Rheumatology Convergence Meeting, Nov 2024. | View source |
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Data from this study may be requested from other researchers 3 years after the completion of the primary endpoint by contacting Dr. Grace Lo.
3 years after the completion of the primary endpoint
To be determined on a case by case basis.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | All randomized participants | Posted | Mean | 95% Confidence Interval | units on a scale | 24 week follow up |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Discomfort from the orthosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grace Lo, Associate Professor of Medicine | Baylor College of Medicine | 713-791-1414 | 227804 | ghlo@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 6, 2022 | Jul 3, 2025 | Prot_SAP_000.pdf |
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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.
An assessment of hand disability. (high values are worse outcomes) Minimum score = 30 Maximum score = 150
| 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 | 24 week follow up |
| Grip Strength | An assessment of the amount of force that can be applied with grip. (low values are worse outcomes) | 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) | 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 | 24 week follow up |
| Houston |
| Texas |
| 77030 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Study Hand VAS | Mean | Standard Deviation | Units on a scale |
|
| OG001 | 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. |
|
|
| 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 | Those participants at the Houston site who were randomized. | Posted | Mean | Standard Deviation | units on a scale | 24 week follow up |
|
|
|
| Secondary | The Functional Index for Hand Osteoarthritis (FIHOA) | An assessment of hand function. (high values are worse outcomes) Minumum score = 0 Maximum score = 30 | All those randomized. | Posted | Mean | 95% Confidence Interval | units on a scale | 24 week follow up |
|
|
|
| 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 | All those randomized. | Posted | Mean | 95% Confidence Interval | units on a scale | 24 week follow up |
|
|
|
| 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 | All participants who were randomized. | Posted | Mean | 95% Confidence Interval | seconds | 24 week follow up |
|
|
|
| Secondary | Grip Strength | An assessment of the amount of force that can be applied with grip. (low values are worse outcomes) | All randomized. | Posted | Mean | 95% Confidence Interval | pounds | 24 week follow up |
|
|
|
| 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) | All randomized. | Posted | Mean | 95% Confidence Interval | pounds | 24 week follow up |
|
|
|
| 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 | All randomized | Posted | Mean | 95% Confidence Interval | score on a scale | 24 week follow up |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 8 |
| 17 |
| EG001 | 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. | 0 | 16 | 0 | 16 | 8 | 16 |
| Skin Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin blistering | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Numbness/Tingling | Nervous system disorders | Systematic Assessment |
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| Fall | Nervous system disorders | Systematic Assessment |
|
| Elective surgery to repair incisional hernia | Eye disorders | Systematic Assessment |
|
| Thoracic spine pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Knee injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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