Carpometacarpal Osteoarthritis
Conditions
Keywords
thumb, trapeziometacarpal, first metacarpal, trapezium
Brief summary
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.
Detailed description
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.
Interventions
OTHERRange of Motion Tasks
Participants will perform range of motion (thumb only) to evaluate fine and gross motor function.
OTHERStrength Tasks
Participants will perform strength (pinch and grip) tests to evaluate fine and gross motor function.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University of Florida
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* CMC OA Subjects: * female between the age of 40 to 90 years * end-stage CMC OA diagnosed by a board-certified clinician * Age-Matched Control: * female between the age of 40 to 90 years * no joint or muscle pain in the hand or wrist
Exclusion criteria
* All Groups: * pregnant women; minors (under age 18); mentally disabled; any persons incarcerated, on parole, on probation, or awaiting trial * individuals with concomitant musculoskeletal pathologies (other than osteoarthritis) in the hand or wrist, including distal radius fracture, contracture, trigger finger, and carpal tunnel * individuals with history of uncontrolled diabetes, rheumatoid arthritis, muscular dysfunction, or neurological disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Australian Canadian OA Hand Index (AUSCAN) | Baseline | 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. |
| Disabilities of the Arm, Shoulder, and Hand (DASH) | Baseline | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment Cohorts: Participants were recruited in two groups: CMC OA (diagnosed by clinician; recruited from orthopaedic clinic) and age-matched controls (recruited from community).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 16 |
| Total | 31 |
Baseline characteristics
| Characteristic | End-Stage CMC OA | Early-Stage CMC OA (Control) | Total |
|---|---|---|---|
| Age, Continuous | 68.1 years STANDARD_DEVIATION 10.4 | 59.9 years STANDARD_DEVIATION 11.2 | 62.9 years STANDARD_DEVIATION 11.3 |
| Body Mass Index (BMI) | 26.6 kg/m^2 STANDARD_DEVIATION 4.6 | 26.8 kg/m^2 STANDARD_DEVIATION 4.9 | 26.7 kg/m^2 STANDARD_DEVIATION 4.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 15 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 12 Participants | 26 Participants |
| Region of Enrollment United States | 15 participants | 16 participants | 31 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 16 |
| other Total, other adverse events | 1 / 15 | 1 / 16 |
| serious Total, serious adverse events | 0 / 15 | 0 / 16 |
Outcome results
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.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| End-Stage CMC OA | Australian Canadian OA Hand Index (AUSCAN) | AUSCAN Pain | 3.3 score on a scale | Standard Deviation 2.6 |
| End-Stage CMC OA | Australian Canadian OA Hand Index (AUSCAN) | AUSCAN Stiffness | 2.0 score on a scale | Standard Deviation 2 |
| End-Stage CMC OA | Australian Canadian OA Hand Index (AUSCAN) | AUSCAN Function | 3.7 score on a scale | Standard Deviation 2.8 |
| Early-Stage CMC OA (Control) | Australian Canadian OA Hand Index (AUSCAN) | AUSCAN Pain | 1.3 score on a scale | Standard Deviation 2 |
| Early-Stage CMC OA (Control) | Australian Canadian OA Hand Index (AUSCAN) | AUSCAN Stiffness | 1.6 score on a scale | Standard Deviation 2.3 |
| Early-Stage CMC OA (Control) | Australian Canadian OA Hand Index (AUSCAN) | AUSCAN Function | 1.6 score on a scale | Standard Deviation 2.2 |
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| End-Stage CMC OA | Disabilities of the Arm, Shoulder, and Hand (DASH) | 27.8 score on a scale | Standard Deviation 22.2 |
| Early-Stage CMC OA (Control) | Disabilities of the Arm, Shoulder, and Hand (DASH) | 15.3 score on a scale | Standard Deviation 16.4 |