Clinical trial NCT03126279: fMRI and Central Sensitization in Chronic Knee Osteoarthritis. A Pre and Post TKR Study
Official title: Predicting Chronic Post TKR Pain by Assessing Central Sensitisation Using Functional Brain MRI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Pain
Postoperative Pain
Surgery
Keywords: Osteoarthritis
Pain
Postoperative Pain
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Aalborg University
name: Medical Research Council
name: Arthritis Research UK
name: Royal College of Surgeons of Edinburgh
First posted: 2017-04-24
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with predominelaty unilateral knee osteoarthritis awaiting for total knee replacement surgery for pain will be included. Patients will recruited from Nottingham University Hospitals NHS Trust. Healthy volunteers will also be recruited as part of this study and they will be recruited from posters and advertisement within the university.

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Brain activity related to temporal summation of pain in healthy individuals and OA patients using a novel fMRI cuff algometer.
timeFrame: 6 months post total knee replacement surgery
Secondary outcomes:
measure: Assessment of knee pain using the Visual Analogue Scale for Pain (0-10)
timeFrame: 6 months post total knee replacement surgery
measure: Assessment of improvement in the Oxford Knee Score
timeFrame: 6 months post total knee replacement surgery
measure: Assessment of change in healthy related quality of life measure using the EQ5D-5L questionnaire
timeFrame: 6 months post total knee replacement
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Academic Division of Trauma, Orthopaedics and Sports Medicine
state: Nottinghamshire
Study officials:
affiliation: The University of Nottingham
name: Dorothee P Auer, PhD
role: PRINCIPAL_INVESTIGATOR
References: