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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Lise Laclautre
- 電話番号：0473754963
- メール：promo_interne_drci@chu-clermontferrand.fr
研究場所
-
-
-
Clermont-Ferrand、フランス
- CHU clermont-ferrand
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主任研究者：
- Sylvain MATHIEU
-
コンタクト：
- Lise Laclautre
- 電話番号：0473754963
- メール：promo_interne_drci@chu-clermontferrand.fr
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Paris、フランス
- APHP - Pitié-Salpêtrière
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コンタクト：
- Florian BAILLY
- 電話番号：+33142161194
- メール：Florian.bailly@aphp.fr
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主任研究者：
- Florian BAILLY
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Paris、フランス
- APHP - Saint-Antoine
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主任研究者：
- Jérémie SELLAM
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コンタクト：
- Jérémie SELLAM
- 電話番号：+33149282520
- メール：Jeremie.sellam@aphp.fr
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Nociceptive pain knee osteroarthritis
Participants with painful knee osteoarthritis classified as having nociceptive pain based on PainDETECT questionnaire score ≤12.
|
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.
|
|
他の：Neuropathic-like pain knee osteoarthritis
Participants with painful knee osteoarthritis classified as having neuropathic-like pain based on PainDETECT questionnaire score >13.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Resting-state anterior insula activity measured by functional MRI (BOLD signal amplitude)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Functional connectivity of the anterior insula with pain-related brain regions (resting-state MRI)
時間枠：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)
時間枠：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)
|
|
Correlation between clinical pain scores ans anterior insula functional connectivity (resting-state fMRI)
時間枠：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.
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Clinical measures at visit 1 ; imaging at visit 2 (within 30 days after inclusion)
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient clusters identified using multimodal analysis including functional MRI and clinical data
時間枠：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
|
Data collected at Visit 1 and Visit 2 (within 30 days after inclusion)
|
協力者と研究者
捜査官
- 主任研究者：Sylvain MATHIEU、University Hospital, Clermont-Ferrand
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- AOI 2025 MATHIEU
- 2025-A02366-43 (その他の識別子：ANSM)
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