Thumb Osteoarthritis Mechanisms

Carpometacarpal Osteoarthritis Clinical Trial

Official title:

Carpometacarpal Osteoarthritis: Towards Identification of Biomechanical, Neuromuscular, and Somatosensory Mechanisms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04104477
• Other study ID #: IRB201900693-N
• Secondary ID: OCR20393KL2TR001
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2021
• Est. completion date: January 2024

Study information

• Verified date: November 2022
• Source: University of Florida
• Contact: Jennifer Nichols, PhD
• Phone: 352-294-8803
• Email: jnichols[@]bme.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpometacarpal Osteoarthritis
• Osteoarthritis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	UF Health of University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graded Chronic Pain Scale (GCPS)	GCPS grades the severity of chronic pain in the general population. GCPS is a seven question survey which yields a "Characteristic Pain Intensity" score and an overall "Disability" score providing insight into global pain severity. Answers are plotted on a scale from 0-10; with 0 being 'no pain' and 10 being 'pain as bad as could be' or 'extreme.'	Baseline