Carpometacarpal OsteoarthritisNCT04104477
Thumb Osteoarthritis: A Cross-Sectional Study of Mechanisms
An observational study of Carpometacarpal Osteoarthritis, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Carpometacarpal Osteoarthritis
- What is being tested?
- Range of Motion Tasks and Strength Tasks
- Type of treatment
- Injection or infusion
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health of University of Florida
Gainesville, Florida, 32610
About this study
Official title: Carpometacarpal Osteoarthritis: Towards Identification of Biomechanical, Neuromuscular, and Somatosensory Mechanisms
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.
Read the 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.
- Conditions
- Carpometacarpal Osteoarthritis
- Being tested
- Range of Motion Tasks, Strength Tasks
- Keywords
- thumb, trapeziometacarpal, first metacarpal, trapezium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Range of Motion TasksOther
Participants will perform range of motion (thumb only) to evaluate fine and gross motor function.
Strength TasksOther
Participants will perform strength (pinch and grip) tests to evaluate fine and gross motor function.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Range of Motion Tasks; Other: Strength Tasks | |
| 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. Receives: Other: Range of Motion Tasks; Other: Strength Tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start26 Feb 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carpometacarpal OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Jennifer Nichols, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104477
- Sponsor's protocol ID
- IRB201900693-N
- Other IDs
- OCR20393, KL2TR001429
- Status last verified
- Aug 2024
- First submitted
- 24 Sep 2019
- Last updated
- 23 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carpometacarpal Osteoarthritis: Towards Identification of Biomechanical, Neuromuscular, and Somatosensory Mechanisms
- ClinicalTrials.gov ID
- NCT04104477
- Acronym / sponsor ID
- IRB201900693-N
- Conditions
- Carpometacarpal Osteoarthritis
- Keywords
- thumb, trapeziometacarpal, first metacarpal, trapezium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Posted 23 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| End-Stage CMC OA | – | Other: Range of Motion Tasks, Other: Strength TasksIndividuals 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. |
| Early-Stage CMC OA (Control) | – | Other: Range of Motion Tasks, Other: Strength TasksIndividuals 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. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- CMC OA Subjects:
- Age-Matched Control:
Key exclusion criteria (4 listed)
- All Groups:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Range of Motion TasksParticipants will perform range of motion (thumb only) to evaluate fine and gross motor function. | Other | Early-Stage CMC OA (Control), End-Stage CMC OA |
| Strength TasksParticipants will perform strength (pinch and grip) tests to evaluate fine and gross motor function. | Other | Early-Stage CMC OA (Control), End-Stage CMC OA |
Primary outcome
Australian Canadian OA Hand Index (AUSCAN)
Time frame: 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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Study on Basal Joint Arthritis Prospective
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Nichols, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpometacarpal Osteoarthritis, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Australian Canadian OA Hand Index (AUSCAN) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.