Functional Brain MRI to Understand Pain Phenotypes in Knee Osteoarthritis (INDIGO)
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Lise Laclautre
- 전화번호: 0473754963
- 이메일: promo_interne_drci@chu-clermontferrand.fr
연구 장소
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Clermont-Ferrand, 프랑스
- CHU clermont-ferrand
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수석 연구원:
- Sylvain MATHIEU
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연락하다:
- Lise Laclautre
- 전화번호: 0473754963
- 이메일: promo_interne_drci@chu-clermontferrand.fr
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Paris, 프랑스
- APHP - Pitié-Salpêtrière
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연락하다:
- Florian BAILLY
- 전화번호: +33142161194
- 이메일: Florian.bailly@aphp.fr
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수석 연구원:
- Florian BAILLY
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Paris, 프랑스
- APHP - Saint-Antoine
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수석 연구원:
- Jérémie SELLAM
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연락하다:
- Jérémie SELLAM
- 전화번호: +33149282520
- 이메일: Jeremie.sellam@aphp.fr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: Nociceptive pain knee osteroarthritis
Participants with painful knee osteoarthritis classified as having nociceptive pain based on PainDETECT questionnaire score ≤12.
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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.
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.
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다른: Neuropathic-like pain knee osteoarthritis
Participants with painful knee osteoarthritis classified as having neuropathic-like pain based on PainDETECT questionnaire score >13.
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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.
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Resting-state anterior insula activity measured by functional MRI (BOLD signal amplitude)
기간: At Visit 2 : within 30 days after inclusion, following Visit 1
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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.
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At Visit 2 : within 30 days after inclusion, following Visit 1
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Functional connectivity of the anterior insula with pain-related brain regions (resting-state MRI)
기간: At Visit 2 : within 30 days after inclusion
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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
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Correlation between clinical pain scores ans anterior insula activity (resting-state fMRI)
기간: Clinical measures at Visit 1 and imaging measures at Visit 2 (within 30 days after inclusion)
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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)
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Correlation between clinical pain scores ans anterior insula functional connectivity (resting-state fMRI)
기간: Clinical measures at visit 1 ; imaging at visit 2 (within 30 days after inclusion)
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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.
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Clinical measures at visit 1 ; imaging at visit 2 (within 30 days after inclusion)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient clusters identified using multimodal analysis including functional MRI and clinical data
기간: Data collected at Visit 1 and Visit 2 (within 30 days after inclusion)
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Identification of patient subgroups based on multimodal integration of imaging and clinical variables
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Data collected at Visit 1 and Visit 2 (within 30 days after inclusion)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Sylvain MATHIEU, University Hospital, Clermont-Ferrand
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AOI 2025 MATHIEU
- 2025-A02366-43 (기타 식별자: ANSM)
개별 참가자 데이터(IPD) 계획
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