Knee OsteoarthritisBioPsyOANCT05734131
Biopsychosocial Assessment in Knee OA
An observational study of Knee Osteoarthritis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Bio-psychosocial assessment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 23 Mar 2022to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients presenting to clinic IRCCS Fondazione Don Carlo Gnocchi, Italy diagnosed with knee OA will be screened for eligibility.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Fondazione Don Carlo Gnocchi, Italy
Rovato
Paolo Pedersini, ppedersini@dongnocchi.it
About this study
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
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Bio-psychosocial assessment
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-psychosocial assessmentOther
Also called 10MWT and TUG test
Kinematic parameters were analyzed by two functional tests, the 10-Meter Walking Test (10MWT) and the Time Up\&Go test (TUG).
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC scale
a patient-reported outcome questionnaire that aims to identify changes in symptoms and activity restrictions in subjects with OA.
Measured: Single assessment at baseline
Secondary outcomes (11)
Pain DETECT Scale
The PainDETECT questionnaire (PD-Q) is a screening instrument designed to classify whether a patient has neuropathic pain.
Measured: Single assessment at baseline
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.
Measured: Single assessment at baseline
Patient Health Questionairre (PHQ-9)
Measured: Single assessment at baseline
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.
Measured: Single assessment at baseline
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.
Measured: Single assessment at baseline
Tampa Kinesiophobia Scale (TSK)
The Tampa Scale for Kinesiophobia (TSK) is a 17-item questionnaire that quantifies fear of movement.
Measured: Single assessment at baseline
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.
Measured: Single assessment at baseline
Injustice Experience Questionnaire (IEQ)
he Injustice Experience Questionnaire (IEQ) assesses the degree to which chronic pain sufferers perceive injustice in relation to their pain.
Measured: Single assessment at baseline
10 meters walking test
10MWT is a standard test used in gait assessment that consists of walking 10 meters in a straight line.
Measured: Single assessment at baseline
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.
Measured: Single assessment at baseline
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.
Measured: Single assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start23 Mar 2022
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734131
- Sponsor's protocol ID
- FDG_biopsycho_OA
- Acronym
- BioPsyOA
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05734131
- Acronym / sponsor ID
- BioPsyOA / FDG_biopsycho_OA
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting to clinic IRCCS Fondazione Don Carlo Gnocchi, Italy diagnosed with knee OA will be screened for eligibility.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio-psychosocial assessmentAlso: 10MWT and TUG testKinematic parameters were analyzed by two functional tests, the 10-Meter Walking Test (10MWT) and the Time Up\&Go test (TUG). | Other | – |
Primary outcome
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.
11 secondary outcomes
Pain DETECT Scale
Time frame: Single assessment at baseline
Central Sensitization Inventory (CSI) Index
Time frame: Single assessment at baseline
Patient Health Questionairre (PHQ-9)
Time frame: Single assessment at baseline
post traumatic distress checklist (PTSD)
Time frame: Single assessment at baseline
Pain Catastrophyzing Scale (PCS)
Time frame: Single assessment at baseline
Tampa Kinesiophobia Scale (TSK)
Time frame: Single assessment at baseline
Fear Avoidance Believe Questionnaire (FABQ)
Time frame: Single assessment at baseline
Injustice Experience Questionnaire (IEQ)
Time frame: Single assessment at baseline
10 meters walking test
Time frame: Single assessment at baseline
Time up and Go test
Time frame: Single assessment at baseline
Pressure pain threshold assessment
Time frame: Single assessment at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Pedersini, MSc (030 72451, ppedersini@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC scale (time frame: Single assessment at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.