Functional Brain MRI to Understand Pain Phenotypes in Knee Osteoarthritis
A legfontosabb adatok
- Ki végzi
- University Hospital, Clermont-Ferrand
- Hol
- Franciaország3 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Toborzás még nem indult
- Fázis
- 2. fázis
- Résztvevők
- 60 fő, tervezett
- Kezdés
- 2026. júl.
- Várható befejezés
- 2028. aug.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoport
- A vizsgált kezelések
- blood sampling
- Resting-state functional MRI
- A regiszteradat frissítve
- 2026. június 25.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
The trial is looking for women aged 40 or older with painful knee osteoarthritis. It compares brain activity at rest on a brain scan (functional MRI) between two types of knee pain.
- Életkor
- 40 years or older
- Nem
- Women only
- A betegség stádiuma
- Osteoarthritis of the knee (femorotibial), diagnosed by the 1986 American College of Rheumatology criteria. Knee pain of at least 4/10, lasting at least 6 months, with at least 15 days of pain in the past 30 days. People with Kellgren-Lawrence X-ray stage IV in one or both knees cannot join.
- Korábbi kezelés
- People who have one or more knee prostheses (artificial knee joints) cannot join. People who took part in an interventional clinical trial in the last 6 months that could affect the main result cannot join.
- Biomarker vagy leletérték
- PainDETECT questionnaire score puts people in one of two groups: nociceptive pain (score ≤ 12) or neuropathic pain (score > 13).
A részvétel fő kizáró okai
- Other joint diseases of the knees, such as gout, chondrocalcinosis, rheumatoid arthritis, spondyloarthritis or psoriatic arthritis
- Conditions causing nerve pain in the legs, such as peripheral neuropathy or chronic radiculopathy, or fibromyalgia
- Knee osteoarthritis at Kellgren-Lawrence stage IV, or one or more knee prostheses
- Claustrophobia or another reason that rules out an MRI
- Pregnant or breastfeeding women
A regiszter feltételei, szó szerint
Mind a 17 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
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).
A teljes eredeti leírásKevesebb
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.
A vizsgálat 2 csoportja
- Nociceptive pain knee osteroarthritisEgyéb csoport
Participants with painful knee osteoarthritis classified as having nociceptive pain based on PainDETECT questionnaire score ≤12.
Kezelés: blood sampling és Resting-state functional MRI
- Neuropathic-like pain knee osteoarthritisEgyéb csoport
Participants with painful knee osteoarthritis classified as having neuropathic-like pain based on PainDETECT questionnaire score \>13.
Kezelés: blood sampling és Resting-state functional MRI
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Functional Brain MRI to Understand Pain Phenotypes in Knee Osteoarthritis: a Multicenter Comparative Pilot Study
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- A regiszteradat frissítve
- 2026. június 25.