fMRI and Central Sensitization in Chronic Knee Osteoarthritis. A Pre and Post TKR Study

Study Overview
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Brief Summary
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Painful osteoarthritis (OA) is the 4th largest cause of disability in the UK. Preoperative temporal summation, a measure of central pain facilitation, has been shown to predict postoperative pain after total knee replacement surgery (TKR). The assessment of the brain's response to noxious stimuli using non-invasive functional MRI (fMRI) may be key in identifying imaging biomarkers within the brain that map central sensitization changes seen in OA. fMRI may help explain why up to 20% of patients undergoing TKR surgery develop persistent post-operative pain. To test these concepts the study aims to functionally characterise the brain activity related to temporal summation of pain in healthy individuals and OA patients using a novel fMRI cuff algometer. Assessment of outcomes in terms of pain and function will be performed 6 months post TKR surgery

Official Title
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Predicting Chronic Post TKR Pain by Assessing Central Sensitisation Using Functional Brain MRI

Conditions
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Osteoarthritis, Pain, Postoperative Pain, Surgery

Intervention / Treatment
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* Procedure: Total Knee Replacement Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OA Group Unilateral Knee OA No previous knee surgery Able to give informed consent Age > 40 years - Healthy Volunteers Group No OA or knee pain Able to give informed consent Age > 40 years Exclusion Criteria: -OA Group Major medical, psychiatric, neurological Cx Other chronic pain condition (fibromyalgia) Contraindications to MRI Active Cancer Neuropathic drug treatment -Healthy Volunteers Group Pregnancy Lower limb pain or previous knee surgery Contraindications to MRI Active Cancer Major medical, psychiatric, neurological condition

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preoperative Chronic Knee OA Patients<br>Patients will be recruited from orthopaedic preoperative clinics from those awaiting total knee replacement surgery. | Procedure: Total Knee Replacement Surgery<br>* All chronic knee osteoarthritis patients will be recruited as they are on the NHS waiting list for a total knee replacement. Only this group will undergo the procedure<br>* Other names: Total;|
| Healthy Volunteers<br>Healthy volunteers will be recruited that are aged match to our OA patient cohort so meaningful comparisons regarding brain activity and pain sensitisation characteristics can be assessed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activity related to temporal summation of pain in healthy individuals and OA patients using a novel fMRI cuff algometer. | Using BOLD fMRI we aim to assess the difference in neural brain activity between patients with chronic knee OA pain and a group of healthy volunteers and to assess the reversal of this activity pattern 6 months post TKR surgery | 6 months post total knee replacement surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of knee pain using the Visual Analogue Scale for Pain (0-10) | Pain using visual analogue scale | 6 months post total knee replacement surgery | 
| Assessment of improvement in the Oxford Knee Score | pain and function outcome measure | 6 months post total knee replacement surgery | 
| Assessment of change in healthy related quality of life measure using the EQ5D-5L questionnaire | quality of life index measure | 6 months post total knee replacement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Osteoarthritis, Postoperative Pain