NCT04104477

Thumb Osteoarthritis: A Cross-Sectional Study of Mechanisms

Completed Results posted Last updated 23 August 2024

What this trial tests

trial testing Range of Motion Tasks in Carpometacarpal Osteoarthritis in 31 participants. Completed in 31 December 2023.

Timeline

26 February 2021

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	University of Florida
Status	Completed
Study type	OBSERVATIONAL
Enrollment	31
Start date	26 February 2021
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Range of Motion Tasks
• Strength Tasks

Conditions studied

• Carpometacarpal Osteoarthritis — all drugs for Carpometacarpal Osteoarthritis →

Sponsor

University of Florida

Who can join

Adults 40 to 90, female only, with Carpometacarpal Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Australian Canadian OA Hand Index (AUSCAN) Primary · 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.

AUSCAN Pain

Group	Value	95% CI
End-Stage CMC OA	3.3	± 2.6
Early-Stage CMC OA (Control)	1.3	± 2.0

AUSCAN Stiffness

Group	Value	95% CI
End-Stage CMC OA	2.0	± 2.0
Early-Stage CMC OA (Control)	1.6	± 2.3

AUSCAN Function

Group	Value	95% CI
End-Stage CMC OA	3.7	± 2.8
Early-Stage CMC OA (Control)	1.6	± 2.2

Disabilities of the Arm, Shoulder, and Hand (DASH) Primary · 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.

Group	Value	95% CI
End-Stage CMC OA	27.8	± 22.2
Early-Stage CMC OA (Control)	15.3	± 16.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Each participant completed three sessions, which could be completed in a single day or across multiple days. Sessions were typically scheduled within 1 to 2 weeks. Adverse event data was collected for each participant during the time period they were enrolled (i.e., during the three sessions), which typically did not exceed 1 month.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

End-Stage CMC OA

Serious: 0/15 (0%)

Deaths: 0/15

Early-Stage CMC OA (Control)

Serious: 0/16 (0%)

Deaths: 0/16

Other adverse events (2 terms — click to expand)

Reaction	System	End-Stage CMC OA	Early-Stage CMC OA (Control)
Vasovagal syncope	Nervous system disorders	—	—
Imparied Vision	Eye disorders	—	—

Data from ClinicalTrials.gov NCT04104477 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.