BioPsyOA
Phenotyping Knee Osteoarthritis Patients According to Patient's Pain Experience and Its Correlation Between Gait Parameters and Time Up&Go Test: an Observational Study
Sponsor study identifier
observational
50
1 country
1
Study Start
March 23, 2022
Actual (reported)Primary Completion
October 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Background: Patient's pain experience is a complex phenomenon. A comprehensive clinical assessment of the patient's pain experience is helpful to define individual differences between patients and thus to plan effective individualized treatment programs. Gait assessment is an important functional task in the clinical evaluation, which allows the definition and modulation of therapeutic intervention. The influence of patient's pain experience on gait parameters is currently understudied in literature. Objective: To investigate patient's pain experience based on an assessment model proposed by Walton and Elliott in patients with knee OA. The study's second aim is to examine the correlation between the parameters of the 10 Meter Walking Test (10MWT) and Time Up and Go test (TUG) assessed by an inertial sensor and the patient's pain experience.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 23, 2022
Actual (reported)February 8, 2023
Actual (reported)February 17, 2023
Actual (reported)October 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
WOMAC scale
a patient-reported outcome questionnaire that aims to identify changes in symptoms and activity restrictions in subjects with OA.
Single assessment at baseline
Pain DETECT Scale
Single assessment at baseline
Central Sensitization Inventory (CSI) Index
Single assessment at baseline
Patient Health Questionairre (PHQ-9)
Single assessment at baseline
post traumatic distress checklist (PTSD)
Single assessment at baseline
Pain Catastrophyzing Scale (PCS)
Single assessment at baseline
Kinematic parameters were analyzed by two functional tests, the 10-Meter Walking Test (10MWT) and the Time Up\&Go test (TUG).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All patients presenting to clinic IRCCS Fondazione Don Carlo Gnocchi, Italy diagnosed with knee OA will be screened for eligibility.
Contact the study team to confirm eligibility.
IRCCS Fondazione Don Carlo Gnocchi, Italy
Rovato, Italy
First Submitted
February 8, 2023
First Posted
February 17, 2023
Study Start
March 23, 2022
Actual (reported)Primary Completion
October 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis
Study Completion
October 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 17, 2023
Record last verified: 2023-02
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Source: ClinicalTrials.gov.
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