Thumb Osteoarthritis: A Cross-Sectional Study of Mechanisms

Completed

• Conditions: Carpometacarpal Osteoarthritis
• Interventions: Other: Range of Motion Tasks; Other: Strength Tasks

• Registration Number: NCT04104477
• Lead Sponsor: University of Florida

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-26
• Study Start: 2021-02-26
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Results First Submitted: 2024-05-29
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-21
• Last Update Submitted: 2024-08-21
• Results First Posted: 2024-08-23
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early-Stage CMC OA (Control)	Range of Motion Tasks	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.
End-Stage CMC OA	Range of Motion Tasks	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.
End-Stage CMC OA	Strength Tasks	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.
Early-Stage CMC OA (Control)	Strength Tasks	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.

Primary Outcome Measures

Name	Time	Method
Australian Canadian OA Hand Index (AUSCAN)	Baseline	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.
Disabilities of the Arm, Shoulder, and Hand (DASH)	Baseline	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.

Trial Locations

Locations (1)

UF Health of University of Florida; 🇺🇸 Gainesville, Florida, United States