Biopsychosocial Assessment in Knee OA

NCT05734131 | Unknown

• 1 other identifier: FDG_biopsycho_OA
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• 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

Interventions

Bio-psychosocial assessment OTHER

Kinematic parameters were analyzed by two functional tests, the 10-Meter Walking Test (10MWT) and the Time Up\&Go test (TUG).

Also known as: 10MWT and TUG test

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients presenting to clinic IRCCS Fondazione Don Carlo Gnocchi, Italy diagnosed with knee OA will be screened for eligibility.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi, Italy

Rovato, Italy

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Paolo Pedersini, MSc

CONTACT

030 72451; ppedersini@dongnocchi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 17, 2023
• Study Start: March 23, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)