Trial Outcomes & Findings for Thumb Osteoarthritis: A Cross-Sectional Study of Mechanisms (NCT NCT04104477)

Last Updated: 2024-08-23

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

31 participants

Primary outcome timeframe

Baseline

Results posted on

2024-08-23

Participant Flow

Recruitment Cohorts: Participants were recruited in two groups: CMC OA (diagnosed by clinician; recruited from orthopaedic clinic) and age-matched controls (recruited from community).

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	15	16
Overall Study COMPLETED	15	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Thumb Osteoarthritis: A Cross-Sectional Study of Mechanisms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	End-Stage CMC OA n=15 Participants 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.	Early-Stage CMC OA (Control) n=16 Participants 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.	Total n=31 Participants Total of all reporting groups
Race (NIH/OMB) White	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	16 participants n=7 Participants	31 participants n=5 Participants
Body Mass Index (BMI)	26.6 kg/m^2 STANDARD_DEVIATION 4.6 • n=5 Participants	26.8 kg/m^2 STANDARD_DEVIATION 4.9 • n=7 Participants	26.7 kg/m^2 STANDARD_DEVIATION 4.6 • n=5 Participants
Age, Continuous	68.1 years STANDARD_DEVIATION 10.4 • n=5 Participants	59.9 years STANDARD_DEVIATION 11.2 • n=7 Participants	62.9 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	End-Stage CMC OA n=15 Participants 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.	Early-Stage CMC OA (Control) n=16 Participants 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.
Australian Canadian OA Hand Index (AUSCAN) AUSCAN Pain	3.3 score on a scale Standard Deviation 2.6	1.3 score on a scale Standard Deviation 2.0
Australian Canadian OA Hand Index (AUSCAN) AUSCAN Stiffness	2.0 score on a scale Standard Deviation 2.0	1.6 score on a scale Standard Deviation 2.3
Australian Canadian OA Hand Index (AUSCAN) AUSCAN Function	3.7 score on a scale Standard Deviation 2.8	1.6 score on a scale Standard Deviation 2.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	End-Stage CMC OA n=15 Participants 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.	Early-Stage CMC OA (Control) n=16 Participants 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.
Disabilities of the Arm, Shoulder, and Hand (DASH)	27.8 score on a scale Standard Deviation 22.2	15.3 score on a scale Standard Deviation 16.4

Adverse Events

End-Stage CMC OA

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Early-Stage CMC OA (Control)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	End-Stage CMC OA n=15 participants at risk 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.	Early-Stage CMC OA (Control) n=16 participants at risk 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.
Nervous system disorders Vasovagal syncope	6.7% 1/15 • Number of events 1 • 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)	0.00% 0/16 • 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)
Eye disorders Imparied Vision	0.00% 0/15 • 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)	6.2% 1/16 • Number of events 1 • 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)

Additional Information

Jennifer Nichols, Ph.D.

University of Florida

Phone: 352-294-8803

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place