Thumb Osteoarthritis: A Cross-Sectional Study of Mechanisms

NCT04104477 | Completed Results

• 3 other identifiers: IRB201900693-NOCR20393KL2TR001429
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpometacarpal Osteoarthritis

Keywords

thumb, trapeziometacarpal, first metacarpal, trapezium

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline

Study Arms (2)

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.

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.

Other: Range of Motion Tasks; Other: Strength Tasks

Interventions

Range of Motion Tasks OTHER

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

Early-Stage CMC OA (Control); End-Stage CMC OA

Strength Tasks OTHER

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

Early-Stage CMC OA (Control); End-Stage CMC OA

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

UF Health of University of Florida

Gainesville, Florida, 32610, United States

Location

Results Point of Contact

• Title: Jennifer Nichols, Ph.D.
• Organization: University of Florida

jnichols@ufl.edu

352-294-8803

Study Officials

• Jennifer Nichols, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: February 26, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)