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| ID | Type | Description | Link |
|---|---|---|---|
| OCR20393 | Other Identifier | UF OnCore | |
| KL2TR001429 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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This study examines carpometacarpal osteoarthritis (CMC OA) and aims to elucidate the biomechanical, neuromuscular, and somatosensory mechanisms that contribute to CMC OA symptoms by using orthopaedic biomechanics and quantitative pain testing. Completion of this study will provide a comprehensive dataset describing how movement strategies (muscle activity and joint posture) as well as experimental and clinical pain differ between individuals with CMC OA and age-matched controls.
This study was funded by that National Institutes of Health through KL2 TR001429 and was registered as a clinical trial at the request of the funding agency. The goal of this exploratory, career development project was to conduct an observational, cross-sectional study of individuals with and without carpometacarpal osteoarthritis (CMC OA). Interestingly, even though approximately a third of postmenopausal women have radiographic evidence of CMC OA, less than ten percent of all women visit the doctor with painful symptoms. This disconnect between radiographic evidence of disease and presence of painful, clinical symptoms makes CMC OA challenging to study. Here, participants were recruited into two groups: CMC OA and age-matched controls. Participants with CMC OA were defined as those recruited from orthopaedic clinics with a diagnosis of CMC OA. Age-matched controls were defined as those recruited from the community who reported during screening that they had no pain or clinical symptoms of CMC OA. All participants participated in two sessions, a biomechanics session to evaluate movement (muscle activity, joint posture) and a somatosensory testing session to evaluate pain sensitization. All participants also completed clinical outcome measures and a hand x-ray. Analyses were completed on two groups based on radiographic evidence of CMC OA: early-stage and end-stage. Note, participant assignment to the analysis groups did not necessarily match the recruitment groups, as some control subjects had radiographic evidence of end-stage CMC OA and some individuals with diagnosed CMC OA had radiographic evidence of early-stage disease. The goal of this study was to build a small, comprehensive dataset describing how movement strategies (muscle activity and joint posture) as well as experimental and clinical pain differ across individuals with CMC OA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| End-Stage CMC OA | Individuals in this group had radiographic evidence of end-stage CMC OA defined as Eaton-Littler Stage III or Stage IV. During testing, participants will be asked to perform range of motion tasks, as well as strength tasks at varying effort levels (maximal and sub-maximal). Through a combination of quantitative testing and self-reported assessments, data on experimental pain, clinical pain, hand function, and disease severity will be reported. |
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| Early-Stage CMC OA (Control) | Individuals in this group had radiographic evidence of early-stage CMC OA defined as Eaton-Littler Stage I or Stage II. Note, the Eaton-Littler scale does not include a stage 0, thus no evidence of disease falls under Stage I. During testing, participants will be asked to perform range of motion tasks, as well as strength tasks at varying effort levels (maximal and sub-maximal). Through a combination of quantitative testing and self-reported assessments, data on experimental pain, clinical pain, hand function, and disease severity will be reported. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Range of Motion Tasks | Other | Participants will perform range of motion (thumb only) to evaluate fine and gross motor function. |
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| Measure | Description | Time Frame |
|---|---|---|
| Australian Canadian OA Hand Index (AUSCAN) | The AUSCAN assesses health status and health outcomes in osteoarthritis of the hand. Participants complete 15 questions targeting their pain, stiffness, and physical function using a 5-point scale. The pain section is scored from 0-20, stiffness from 0-4, and function from 0-10. Higher score indicates worse self-reported outcomes. | Baseline |
| Disabilities of the Arm, Shoulder, and Hand (DASH) | The DASH is a 30-item questionnaire that assesses an individual's ability to perform upper extremity activities. Participants rate the difficulty and interference of with daily life using a 5-point scale. Scores are reported from 0-100 with higher scores indicating worse self-reported outcomes. | Baseline |
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Inclusion Criteria:
CMC OA Subjects:
Age-Matched Control:
Exclusion Criteria:
All Groups:
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All participants were recruited from North Central Florida. Participants with clinically-diagnosed CMC OA were recruited from local orthopaedic surgery clinics. Age-matched control subjects were recruited from the community.
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Nichols, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health of University of Florida | Gainesville | Florida | 32610 | United States |
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Analysis Cohorts: Using hand x-rays obtained during testing, participants were assigned to early-stage and end-stage OA cohorts for analysis. This accounted for the fact that individuals with CMC OA do not always seek clinical care.
Recruitment Cohorts: Participants were recruited in two groups: CMC OA (diagnosed by clinician; recruited from orthopaedic clinic) and age-matched controls (recruited from community).
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| ID | Title | Description |
|---|---|---|
| FG000 | End-Stage CMC OA | During testing, participants will be asked to perform range of motion tasks, as well as strength tasks at varying effort levels (maximal and sub-maximal). Through a combination of quantitative testing and self-reported assessments, data on experimental pain, clinical pain, hand function, and disease severity will be reported. Range of Motion Tasks: Participants will perform range of motion (thumb only) to evaluate fine and gross motor function. Strength Tasks: Participants will perform strength (pinch and grip) tests to evaluate fine and gross motor function. |
| FG001 | Early-Stage CMC OA (Control) | During testing, participants will be asked to perform range of motion tasks, as well as strength tasks at varying effort levels (maximal and sub-maximal). Through a combination of quantitative testing and self-reported assessments, data on experimental pain, clinical pain, hand function, and disease severity will be reported. Range of Motion Tasks: Participants will perform range of motion (thumb only) to evaluate fine and gross motor function. Strength Tasks: Participants will perform strength (pinch and grip) tests to evaluate fine and gross motor function. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | End-Stage CMC OA | During testing, participants will be asked to perform range of motion tasks, as well as strength tasks at varying effort levels (maximal and sub-maximal). Through a combination of quantitative testing and self-reported assessments, data on experimental pain, clinical pain, hand function, and disease severity will be reported. Range of Motion Tasks: Participants will perform range of motion (thumb only) to evaluate fine and gross motor function. Strength Tasks: Participants will perform strength (pinch and grip) tests to evaluate fine and gross motor function. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Australian Canadian OA Hand Index (AUSCAN) | The AUSCAN assesses health status and health outcomes in osteoarthritis of the hand. Participants complete 15 questions targeting their pain, stiffness, and physical function using a 5-point scale. The pain section is scored from 0-20, stiffness from 0-4, and function from 0-10. Higher score indicates worse self-reported outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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Each participant completed three sessions, which could be completed in a single day or across multiple days. Sessions were typically scheduled within 1 to 2 weeks. Adverse event data was collected for each participant during the time period they were enrolled (i.e., during the three sessions), which typically did not exceed 1 month.
Definitions based on interference with daily activities: Mild (easily tolerated, cause minimal discomfort), Moderate (sufficient discomfort to interfere with daily activities), Severe (prevents daily activities)
Relationship to study: Unrelated (no association between study intervention and reported event), Related (definite causal relationship exists between the event and the study), Cannot be ruled out (the event might be related to the study, but could also be produced by other factors)
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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 | End-Stage CMC OA | During testing, participants will be asked to perform range of motion tasks, as well as strength tasks at varying effort levels (maximal and sub-maximal). Through a combination of quantitative testing and self-reported assessments, data on experimental pain, clinical pain, hand function, and disease severity will be reported. Range of Motion Tasks: Participants will perform range of motion (thumb only) to evaluate fine and gross motor function. Strength Tasks: Participants will perform strength (pinch and grip) tests to evaluate fine and gross motor function. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vasovagal syncope | Nervous system disorders | Related, mild | Non-systematic Assessment | Vasovagal syncope in response to insertion of fine wire needle electrodes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Nichols, Ph.D. | University of Florida | 352-294-8803 | jnichols@ufl.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 29, 2024 | Aug 21, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 29, 2023 | May 9, 2024 | ICF_001.pdf |
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| Strength Tasks | Other | Participants will perform strength (pinch and grip) tests to evaluate fine and gross motor function. |
|
| BG001 | Early-Stage CMC OA (Control) | During testing, participants will be asked to perform range of motion tasks, as well as strength tasks at varying effort levels (maximal and sub-maximal). Through a combination of quantitative testing and self-reported assessments, data on experimental pain, clinical pain, hand function, and disease severity will be reported. Range of Motion Tasks: Participants will perform range of motion (thumb only) to evaluate fine and gross motor function. Strength Tasks: Participants will perform strength (pinch and grip) tests to evaluate fine and gross motor function. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| OG001 | Early-Stage CMC OA (Control) | During testing, participants will be asked to perform range of motion tasks, as well as strength tasks at varying effort levels (maximal and sub-maximal). Through a combination of quantitative testing and self-reported assessments, data on experimental pain, clinical pain, hand function, and disease severity will be reported. Range of Motion Tasks: Participants will perform range of motion (thumb only) to evaluate fine and gross motor function. Strength Tasks: Participants will perform strength (pinch and grip) tests to evaluate fine and gross motor function. |
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| Primary | Disabilities of the Arm, Shoulder, and Hand (DASH) | The DASH is a 30-item questionnaire that assesses an individual's ability to perform upper extremity activities. Participants rate the difficulty and interference of with daily life using a 5-point scale. Scores are reported from 0-100 with higher scores indicating worse self-reported outcomes. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 0 |
| 15 |
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | Early-Stage CMC OA (Control) | During testing, participants will be asked to perform range of motion tasks, as well as strength tasks at varying effort levels (maximal and sub-maximal). Through a combination of quantitative testing and self-reported assessments, data on experimental pain, clinical pain, hand function, and disease severity will be reported. Range of Motion Tasks: Participants will perform range of motion (thumb only) to evaluate fine and gross motor function. Strength Tasks: Participants will perform strength (pinch and grip) tests to evaluate fine and gross motor function. | 0 | 16 | 0 | 16 | 1 | 16 |
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| Imparied Vision | Eye disorders | Unrelated, mild | Non-systematic Assessment | Impaired peripheral vision |
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