Biopsychosocial Assessment in Knee OA (BioPsyOA)

February 8, 2023 updated by: Fondazione Don Carlo Gnocchi Onlus

Phenotyping Knee Osteoarthritis Patients According to Patient's Pain Experience and Its Correlation Between Gait Parameters and Time Up&Go Test: an Observational Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Each patient undergoes a clinical pain assessment including Western Ontario and McMaster University Osteoarthritis (WOMAC) scale, a patient-reported outcome questionnaire that aims to identify changes in symptoms and activity restrictions in subjects with OA. A guided clinical assessment explores nociceptive, neuropathic, nociplastic, psychological, beliefs, socioenvironmental, and sensorimotor disintegration domains. A series of assessment scales were considered for each patient: Pain DETECT Scale; Central Sensitization Inventory (CSI) Index; Patient Health Questionairre (PHQ-9); post traumatic distress checklist (PTSD); Pain Catastrophyzing Scale (PCS); Tampa Kinesiophobia Scale (TSK); Fear Avoidance Believe Questionnaire (FABQ), Injustice Experience Questionnaire (IEQ) and the completion of a body chart.

An assessment of pressure pain threshold (PPT) was conducted through an electronic algometer (Algomed). The defined sites for PPT were the patella, Gerdy's tubercle, and the forearm on the extensor digitorum. The examiner applied gradual pressure on the defined areas, and patients were asked to report the exact moment when the pressure began to change to a sensation of pain. At that time, the examiner terminated the application of pressure, and the measurement related to the PPT was taken.

Kinematic parameters were analyzed by two functional tests, the 10-Meter Walking Test (10MWT) and the Time Up&Go test (TUG). The tests were carried out with the help of an inertial sensor (BTS G-Sensor), placed at the trunk level, above the subject's clothing, via an elastic belt. 10MWT is a standard test used in gait assessment that consists of walking 10 meters in a straight line; TUG is a common and validated test that provides important indications about the level of balance and functional and walking ability of subjects. The test consists of getting up from a chair, walking 3 meters, turning around, returning to the chair, and sitting down. The inertial sensor registered the spatio-temporal parameters during 10MWT and TUG.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

Inclusion criteria for this study are age 50 and 90 years, Body Mass Index (BMI) <30 kg/m2, and Knee OA symptoms. OA is confirmed by the treating physician and radiographic findings (severity of OA 2 to 4 Kellgren-Lawrence scale).

Exclusion Criteria:

Exclusion Criteria are the presence of psychiatric or neurological disorders, peripheral nerve injury, uncontrolled inflammatory states, neuromuscular and rheumatologic diseases, dementia and language barriers, limiting orthopedic conditions (amputations, non-reducible joint limitations), post-traumatic OA (e.g., fractures), congenital hip deformities, hip surgery, Legg-Calvé-Perthes disease. Patients with degenerative or non-degenerative neurological conditions in which pain perception is impaired and ongoing corticosteroid infiltration, and bedridden subjects are excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC scale
Time Frame: Single assessment at baseline
a patient-reported outcome questionnaire that aims to identify changes in symptoms and activity restrictions in subjects with OA.
Single assessment at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain DETECT Scale
Time Frame: Single assessment at baseline
The PainDETECT questionnaire (PD-Q) is a screening instrument designed to classify whether a patient has neuropathic pain.
Single assessment at baseline
Central Sensitization Inventory (CSI) Index
Time Frame: Single assessment at baseline
The Central Sensitisation Inventory (CSI) is a self-report outcome measure designed to identify patients with symptoms related to central sensitization.
Single assessment at baseline
Patient Health Questionairre (PHQ-9)
Time Frame: Single assessment at baseline
Single assessment at baseline
post traumatic distress checklist (PTSD)
Time Frame: Single assessment at baseline
The PCL-5 is a 20-item self-report checklist of PTSD symptoms based closely on the DSM-5 criteria.
Single assessment at baseline
Pain Catastrophyzing Scale (PCS)
Time Frame: Single assessment at baseline
The Pain Catastrophizing Scale (PCS) assesses the extent of catastrophic thinking due to pain according to 3 components: rumination, magnification, and helplessness.
Single assessment at baseline
Tampa Kinesiophobia Scale (TSK)
Time Frame: Single assessment at baseline
The Tampa Scale for Kinesiophobia (TSK) is a 17-item questionnaire that quantifies fear of movement.
Single assessment at baseline
Fear Avoidance Believe Questionnaire (FABQ)
Time Frame: Single assessment at baseline
The Fear-Avoidance Beliefs Questionnaire (FABQ) is a patient-reported questionnaire that specifically focuses on a patient's fear avoidance beliefs.
Single assessment at baseline
Injustice Experience Questionnaire (IEQ)
Time Frame: Single assessment at baseline
he Injustice Experience Questionnaire (IEQ) assesses the degree to which chronic pain sufferers perceive injustice in relation to their pain.
Single assessment at baseline
10 meters walking test
Time Frame: Single assessment at baseline
10MWT is a standard test used in gait assessment that consists of walking 10 meters in a straight line.
Single assessment at baseline
Time up and Go test
Time Frame: Single assessment at baseline
TUG is a common and validated test that provides important indications about the level of balance and functional and walking ability of subjects. The test consists of getting up from a chair, walking 3 meters, turning around, returning to the chair, and sitting down.
Single assessment at baseline
Pressure pain threshold assessment
Time Frame: Single assessment at baseline
An assessment of pressure pain threshold (PPT) was conducted through an electronic algometer (Algomed)17. The defined sites for PPT were the patella, Gerdy's tubercle, and the forearm on the extensor digitorum. The examiner applied gradual pressure on the defined areas, and patients were asked to report the exact moment when the pressure began to change to a sensation of pain. At that time, the examiner terminated the application of pressure, and the measurement related to the PPT was taken.
Single assessment at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2022

Primary Completion (Anticipated)

October 31, 2023

Study Completion (Anticipated)

October 31, 2023

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDG_biopsycho_OA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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