Thumb Osteoarthritis: A Cross-Sectional Study of Mechanisms

NCT ID: NCT04104477

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-26
• Study Completion Date: 2023-12-31

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.

Detailed Description

This study was funded by that National Institutes of Health through KL2 TR001429 and was registered as a clinical trial at the request of the funding agency. The goal of this exploratory, career development project was to conduct an observational, cross-sectional study of individuals with and without carpometacarpal osteoarthritis (CMC OA). Interestingly, even though approximately a third of postmenopausal women have radiographic evidence of CMC OA, less than ten percent of all women visit the doctor with painful symptoms. This disconnect between radiographic evidence of disease and presence of painful, clinical symptoms makes CMC OA challenging to study. Here, participants were recruited into two groups: CMC OA and age-matched controls. Participants with CMC OA were defined as those recruited from orthopaedic clinics with a diagnosis of CMC OA. Age-matched controls were defined as those recruited from the community who reported during screening that they had no pain or clinical symptoms of CMC OA. All participants participated in two sessions, a biomechanics session to evaluate movement (muscle activity, joint posture) and a somatosensory testing session to evaluate pain sensitization. All participants also completed clinical outcome measures and a hand x-ray. Analyses were completed on two groups based on radiographic evidence of CMC OA: early-stage and end-stage. Note, participant assignment to the analysis groups did not necessarily match the recruitment groups, as some control subjects had radiographic evidence of end-stage CMC OA and some individuals with diagnosed CMC OA had radiographic evidence of early-stage disease. The goal of this study was to build a small, comprehensive dataset describing how movement strategies (muscle activity and joint posture) as well as experimental and clinical pain differ across individuals with CMC OA.

Conditions

Carpometacarpal Osteoarthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Range of Motion Tasks

Intervention Type: OTHER

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

Strength Tasks

Intervention Type: OTHER

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

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.

Range of Motion Tasks

Intervention Type: OTHER

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

Strength Tasks

Intervention Type: OTHER

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

Interventions

Range of Motion Tasks

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

Intervention Type: OTHER

Strength Tasks

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Nichols, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health of University of Florida

Gainesville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

OCR20393

Identifier Type: OTHER

Identifier Source: secondary_id

KL2TR001429

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201900693-N

Identifier Type: -

Identifier Source: org_study_id