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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Lise Laclautre
- 电话号码：0473754963
- 邮箱：promo_interne_drci@chu-clermontferrand.fr
学习地点
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-
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Clermont-Ferrand、法国
- CHU clermont-ferrand
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首席研究员：
- Sylvain MATHIEU
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接触：
- Lise Laclautre
- 电话号码：0473754963
- 邮箱：promo_interne_drci@chu-clermontferrand.fr
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Paris、法国
- APHP - Pitié-Salpêtrière
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接触：
- Florian BAILLY
- 电话号码：+33142161194
- 邮箱：Florian.bailly@aphp.fr
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首席研究员：
- Florian BAILLY
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Paris、法国
- APHP - Saint-Antoine
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首席研究员：
- Jérémie SELLAM
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接触：
- Jérémie SELLAM
- 电话号码：+33149282520
- 邮箱：Jeremie.sellam@aphp.fr
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：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.
|
|
其他：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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Resting-state anterior insula activity measured by functional MRI (BOLD signal amplitude)
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Functional connectivity of the anterior insula with pain-related brain regions (resting-state MRI)
大体时间：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)
大体时间：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)
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient clusters identified using multimodal analysis including functional MRI and clinical data
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Sylvain MATHIEU、University Hospital, Clermont-Ferrand
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- AOI 2025 MATHIEU
- 2025-A02366-43 (其他标识符：ANSM)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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