Functional Brain MRI to Understand Pain Phenotypes in Knee Osteoarthritis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age40+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
blood sampling
Biological/VaccineBlood 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 MRI
Procedure/SurgeryResting-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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Nociceptive pain knee osteroarthritisOther 2 interventions
Group B: Neuropathic-like pain knee osteoarthritisOther 2 interventions
Trial outcomes
Primary outcomes
1
Resting-state anterior insula activity measured by functional MRI (BOLD signal amplitude)
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.
Time frame
At Visit 2 : within 30 days after inclusion, following Visit 1Secondary outcomes
1
Functional connectivity of the anterior insula with pain-related brain regions (resting-state MRI)
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).
Time frame
At Visit 2 : within 30 days after inclusion2
Correlation between clinical pain scores ans anterior insula activity (resting-state fMRI)
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.
Time frame
Clinical measures at Visit 1 and imaging measures at Visit 2 (within 30 days after inclusion)3
Correlation between clinical pain scores ans anterior insula functional connectivity (resting-state fMRI)
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.
Time frame
Clinical measures at visit 1 ; imaging at visit 2 (within 30 days after inclusion)Other outcomes
1
Patient clusters identified using multimodal analysis including functional MRI and clinical data
Identification of patient subgroups based on multimodal integration of imaging and clinical variables
Time frame
Data collected at Visit 1 and Visit 2 (within 30 days after inclusion)Sponsors and contacts
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Source ClinicalTrials.gov
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