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Functional Brain MRI to Understand Pain Phenotypes in Knee Osteoarthritis (INDIGO)

23 juin 2026 mis à jour par: University Hospital, Clermont-Ferrand

Functional Brain MRI to Understand Pain Phenotypes in Knee Osteoarthritis: a Multicenter Comparative Pilot Study

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 :

  • complete questionnaires during the inclusion visit and on the day of the scan,
  • undergo a clinical examination and a blood test at the inclusion visit,
  • undergo a functional MRI (fMRI), an imaging test that allows observation of brain activity at rest.

Paticipants in the study does not involve any additional treatment. the fMRI scan is non-invasive and does not require any injections.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • France
      • Clermont-Ferrand, France
      • Paris, France
        • APHP - Pitié-Salpêtrière
        • Contact:
        • Chercheur principal:
          • Florian BAILLY
      • Paris, France
        • APHP - Saint-Antoine
        • Chercheur principal:
          • Jérémie SELLAM
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Women aged 40 or older (only women will be included to ensure consistency in the analyses, given the higher prevalence of osteoarthritis in women and the influence of sex/gender on the experience of pain)
  • Diagnosis of femorotibial osteoarthritis of the knee according to the 1986 American College of Rheumatology criteria
  • Presence of knee pain with an intensity of ≥ 4/10 on a numerical rating scale (NRS)
  • Chronic knee pain, i.e., lasting at least 6 months with at least 15 days of pain in the past 30 days
  • Completion of the PainDETECT questionnaire, which will allow the patient to be assigned to one of two groups prior to the enrollment visit (those with nociceptive pain [score ≤ 12] and those with neuropathic pain [score > 13])
  • Patients have read and understood the information letter
  • Patients have signed the informed consent form
  • Patients are enrolled in a social security program

Exclusion Criteria:

  • Other joint diseases affecting the knees (gout, chondrocalcinosis, rheumatoid arthritis, spondyloarthritis, psoriatic arthritis)
  • Conditions that, in the investigator's opinion, interfere with the assessment of osteoarthritic pain, such as conditions causing neuropathic pain in the lower extremities (e.g., peripheral neuropathy, chronic radiculopathy) or fibromyalgia
  • Kellgren-Lawrence radiographic stage IV in one or both knees
  • Patients with one or more knee prostheses
  • Claustrophobia making MRI impossible
  • Contraindication to MRI
  • Pregnant or breastfeeding women
  • Patients under guardianship, conservatorship, deprived of liberty, or under judicial protection
  • Patients who have participated in an interventional clinical trial within the last 6 months that could impact the primary endpoint

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: Nociceptive pain knee osteroarthritis
Participants with painful knee osteoarthritis classified as having nociceptive pain based on PainDETECT questionnaire score ≤12.
Biologique: blood sampling
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.
Procédure: Resting-state functional MRI
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.
Autre: Neuropathic-like pain knee osteoarthritis
Participants with painful knee osteoarthritis classified as having neuropathic-like pain based on PainDETECT questionnaire score >13.
Biologique: blood sampling
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.
Procédure: Resting-state functional MRI
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Resting-state anterior insula activity measured by functional MRI (BOLD signal amplitude)
Délai: At Visit 2 : within 30 days after inclusion, following Visit 1
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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Functional connectivity of the anterior insula with pain-related brain regions (resting-state MRI)
Délai: At Visit 2 : within 30 days after inclusion

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).
At Visit 2 : within 30 days after inclusion
Correlation between clinical pain scores ans anterior insula activity (resting-state fMRI)
Délai: Clinical measures at Visit 1 and imaging measures at Visit 2 (within 30 days after inclusion)

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)
Délai: Clinical measures at visit 1 ; imaging at visit 2 (within 30 days after inclusion)
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)

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Patient clusters identified using multimodal analysis including functional MRI and clinical data
Délai: Data collected at Visit 1 and Visit 2 (within 30 days after inclusion)
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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University Hospital, Clermont-Ferrand

Les enquêteurs

  • Chercheur principal: Sylvain MATHIEU, University Hospital, Clermont-Ferrand

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

1 août 2028

Achèvement de l'étude (Estimé)

1 août 2028

Dates d'inscription aux études

Première soumission

24 avril 2026

Première soumission répondant aux critères de contrôle qualité

23 juin 2026

Première publication (Réel)

25 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 juin 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • AOI 2025 MATHIEU
  • 2025-A02366-43 (Autre identifiant: ANSM)

Plan pour les données individuelles des participants (IPD)

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NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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