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

23 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Frankrijk
      • Clermont-Ferrand, Frankrijk
      • Paris, Frankrijk
        • APHP - Pitié-Salpêtrière
        • Contact:
        • Hoofdonderzoeker:
          • Florian BAILLY
      • Paris, Frankrijk
        • APHP - Saint-Antoine
        • Hoofdonderzoeker:
          • Jérémie SELLAM
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: Nociceptive pain knee osteroarthritis
Participants with painful knee osteoarthritis classified as having nociceptive pain based on PainDETECT questionnaire score ≤12.
Biologisch: 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.
Procedure: 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.
Ander: Neuropathic-like pain knee osteoarthritis
Participants with painful knee osteoarthritis classified as having neuropathic-like pain based on PainDETECT questionnaire score >13.
Biologisch: 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.
Procedure: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Resting-state anterior insula activity measured by functional MRI (BOLD signal amplitude)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Functional connectivity of the anterior insula with pain-related brain regions (resting-state MRI)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient clusters identified using multimodal analysis including functional MRI and clinical data
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Clermont-Ferrand

Onderzoekers

  • Hoofdonderzoeker: Sylvain MATHIEU, University Hospital, Clermont-Ferrand

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 augustus 2028

Studie voltooiing (Geschat)

1 augustus 2028

Studieregistratiedata

Eerst ingediend

24 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 juni 2026

Eerst geplaatst (Werkelijk)

25 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

23 juni 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AOI 2025 MATHIEU
  • 2025-A02366-43 (Andere identificatie: ANSM)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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