Clinical Trial Finder

Thumb Osteoarthritis Mechanisms

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 40 Years - 90 Years
Gender Female
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04104477
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Florida
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jennifer Nichols, PhD
Principal Investigator Affiliation University of Florida
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Carpometacarpal Osteoarthritis
Arms & Interventions

Arms

Active Comparator: CMC OA Group

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.

Active Comparator: Age-Matched Control Group

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.

Interventions

Other: - Range of Motion Tasks

Participants will perform range of motion (thumb only) to evaluate fine and gross motor function.

Other: - Strength Tasks

Participants will perform strength (pinch and grip) tests to evaluate fine and gross motor function.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UF Health of University of Florida, Gainesville, Florida

Status

Recruiting

Address

UF Health of University of Florida

Gainesville, Florida, 32610

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