search
Back to results

Thumb Osteoarthritis Mechanisms

Primary Purpose

Carpometacarpal Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Range of Motion Tasks
Strength Tasks
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Carpometacarpal Osteoarthritis

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • UF Health of University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CMC OA Group

Age-Matched Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.'

Secondary Outcome Measures

Full Information

First Posted
September 24, 2019
Last Updated
November 21, 2022
Sponsor
University of Florida
Collaborators
National Center for Advancing Translational Sciences (NCATS)
search

1. Study Identification

Unique Protocol Identification Number
NCT04104477
Brief Title
Thumb Osteoarthritis Mechanisms
Official Title
Carpometacarpal Osteoarthritis: Towards Identification of Biomechanical, Neuromuscular, and Somatosensory Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpometacarpal Osteoarthritis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CMC OA Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Age-Matched Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Range of Motion Tasks
Intervention Description
Participants will perform range of motion (thumb only) to evaluate fine and gross motor function.
Intervention Type
Other
Intervention Name(s)
Strength Tasks
Intervention Description
Participants will perform strength (pinch and grip) tests to evaluate fine and gross motor function.
Primary Outcome Measure Information:
Title
Graded Chronic Pain Scale (GCPS)
Description
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.'
Time Frame
Baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Nichols, PhD
Phone
352-294-8803
Email
jnichols@bme.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Nichols, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health of University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Thumb Osteoarthritis Mechanisms

We'll reach out to this number within 24 hrs