Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02366-43 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Some people with knee osteoarthritis (gonarthrosis) experience pain differently. In some, the pain is described as "nociceptive" (directly related to the joint), while in others it has "neuropathic" characteristics (related to nerve function).
The goal of this multicenter, cross-sectional and comparative study is to compare resting brain activity in a brain region called the anterior insula among female patients with painful knee osteoarthritis who experience nociceptive pain compared to those with neuropathic pain.
Researchers will compare brain activity at rest between these two types of pain in women over 40 with painful knee osteoarthritis. A better understanding could help improve pain management in the future.
Participants will be asked to :
Paticipants in the study does not involve any additional treatment. the fMRI scan is non-invasive and does not require any injections.
This study will include patients with painful knee osteoarthritis (pain scoring ≥ 4/10 on the Numerical Rating Scale (NRS)). Patients matched by age (within 3 years) will be divided into two groups based on their PainDETECT score: those with nociceptive pain (score ≤ 12) and those with neuropathic pain (score > 13).
Participants will be recruited from three rheumatology centers (30 in Clermont-Ferrand, 15 at Saint-Antoine Hospital, and 15 at Pitié-Salpêtrière Hospital in Paris). The rheumatologist will verify eligibility and provide information during the pre-enrollment consultation, within 30 days prior to enrollment. After obtaining their informed consent, patients will attend the enrollment visit and be assigned to a group based on their PainDETECT score.
Each participant will undergo a clinical evaluation, including the following PRO measures: Lequesne and WOMAC functional indices, EuroQol EQ-5D, Hospital Anxiety and Depression Scale, fatigue and pain intensity scales, Catastrophizing Scale (PCS), ICOAP, OASIS, and Flare-OA scales. A QST test will also be performed using the Neogi method, which includes pressure pain thresholds, conditioned pain modulation, and temporal pain summation.
A blood test will be performed, including high-sensitivity CRP and metabolic markers (lipid profile, HbA1c, and fasting blood glucose), due to the link between metabolic syndrome and osteoarthritic pain.
Within 30 days of enrollment, participants will undergo an fMRI scan at the radiology department in Clermont-Ferrand or at La Pitié-Salpêtrière. On the day of the scan, participants will complete additional self-reports of knee pain using the questionnaires. Interpretation of the fMRI data will be centralized in Clermont-Ferrand.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nociceptive pain knee osteroarthritis | Other | Participants with painful knee osteoarthritis classified as having nociceptive pain based on PainDETECT questionnaire score ≤12. |
|
| Neuropathic-like pain knee osteoarthritis | Other | Participants with painful knee osteoarthritis classified as having neuropathic-like pain based on PainDETECT questionnaire score >13. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sampling | Biological | Blood sampling will be performed at the inclusion visit. A biological assessment will include high sensitivity C reactive protein (hs-CRP) and metabolic markers (lipid profile, HbA1c, and fasting glucose). Additional blood samples (4 tubes) will be collected for biobank, including plasma and serum storage for the measurement of inflammatory markers. |
| Measure | Description | Time Frame |
|---|---|---|
| Resting-state anterior insula activity measured by functional MRI (BOLD signal amplitude) | Comparison of resting-state anterior insula brain activity between patients with painful knee osteoarthritis with nociceptive pain and those with neuropathic-like pain, classified using the painDETECT questionnaire. | At Visit 2 : within 30 days after inclusion, following Visit 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional connectivity of the anterior insula with pain-related brain regions (resting-state MRI) | Functional connectivity between the anterior insula (seed region) and predefined pain-related brain regions (S1, M1, posterior incula, ACC, MCC, vmPFC, DLPFC, thalamus) will be quantified using seed-basing resting-state fMRI analysis. Connectivity values will be expressed as Fisher-transformed correlation coefficients (z-scores). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient clusters identified using multimodal analysis including functional MRI and clinical data | Identification of patient subgroups based on multimodal integration of imaging and clinical variables | Data collected at Visit 1 and Visit 2 (within 30 days after inclusion) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | 0473754963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Sylvain MATHIEU | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D009437 | Neuralgia |
| D059226 | Nociceptive Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Resting-state functional MRI | Procedure | Resting-state functional brain MRI will be performed at Visit 2 (within 30 days of the screening visit). Participants will undergo a brain MRI acquisition at rest to evaluate anterior insula activity and functional connectivity with pain-related brain regions. |
|
| At Visit 2 : within 30 days after inclusion |
| Correlation between clinical pain scores ans anterior insula activity (resting-state fMRI) | Correlation between clinical pain measures collected at visit 1 (painDETECT score, BAS pain intensity, WOMAC pain subscale, ICOAP score) and anterior insula activity measured at visit 2. Anterior insula activity will be quantified using the beta coefficient from the general linear model (GLM) of resting-state fMRI. | Clinical measures at Visit 1 and imaging measures at Visit 2 (within 30 days after inclusion) |
| Correlation between clinical pain scores ans anterior insula functional connectivity (resting-state fMRI) | Correlation between clinical pain measures collected at visit 1 (painDETECT, VAS, WOMAC, ICOAP) and functional connectivity z-scores between the anterior insula ans pain-related brain regions measured at visit 2. | Clinical measures at visit 1 ; imaging at visit 2 (within 30 days after inclusion) |
| APHP - Pitié-Salpêtrière | Paris | France |
|
| APHP - Saint-Antoine | Paris | France |
|
| D012216 |
| Rheumatic Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |