Biopsychosocial Assessment in Knee OA

Knee Osteoarthritis Clinical Trial

— BioPsyOA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05734131
• Other study ID #: FDG_biopsycho_OA
• Status: Recruiting
• Start date: March 23, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2023
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Paolo Pedersini, MSc
• Phone: 030 72451
• Email: ppedersini[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Bio-psychosocial assessment
Kinematic parameters were analyzed by two functional tests, the 10-Meter Walking Test (10MWT) and the Time Up&Go test (TUG).

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Don Carlo Gnocchi, Italy	Rovato

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain DETECT Scale	The PainDETECT questionnaire (PD-Q) is a screening instrument designed to classify whether a patient has neuropathic pain.	Single assessment at baseline
Secondary	Central Sensitization Inventory (CSI) Index	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
Secondary	Patient Health Questionairre (PHQ-9)		Single assessment at baseline
Secondary	post traumatic distress checklist (PTSD)	The PCL-5 is a 20-item self-report checklist of PTSD symptoms based closely on the DSM-5 criteria.	Single assessment at baseline
Secondary	Pain Catastrophyzing Scale (PCS)	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
Secondary	Tampa Kinesiophobia Scale (TSK)	The Tampa Scale for Kinesiophobia (TSK) is a 17-item questionnaire that quantifies fear of movement.	Single assessment at baseline
Secondary	Fear Avoidance Believe Questionnaire (FABQ)	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
Secondary	Injustice Experience Questionnaire (IEQ)	he Injustice Experience Questionnaire (IEQ) assesses the degree to which chronic pain sufferers perceive injustice in relation to their pain.	Single assessment at baseline
Secondary	10 meters walking test	10MWT is a standard test used in gait assessment that consists of walking 10 meters in a straight line.	Single assessment at baseline
Secondary	Time up and Go test	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
Secondary	Pressure pain threshold assessment	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