Thumb Osteoarthritis Mechanisms

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.

Study Overview

• Status: Recruiting
• Conditions: Carpometacarpal Osteoarthritis
• Intervention / Treatment: Other: Range of Motion Tasks; Other: Strength Tasks

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Nichols, PhD; Phone Number: 352-294-8803; Email: jnichols@bme.ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • UF Health of University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Jennifer Nichols, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 26, 2021
• Primary Completion (ANTICIPATED): January 1, 2024
• Study Completion (ANTICIPATED): January 1, 2024

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (ACTUAL): September 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: IRB201900693-N; KL2TR001429 (U.S. NIH Grant/Contract); OCR20393 (OTHER: UF OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No