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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03126279
Enrollment
50
Registered
2017-04-24
Start date
2015-08-31
Completion date
2017-08-31
Last updated
2017-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Pain, Postoperative Pain, Surgery

Keywords

Osteoarthritis, Pain, Postoperative Pain

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

Interventions

PROCEDURETotal Knee Replacement Surgery

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

Sponsors

Aalborg University
CollaboratorOTHER
Medical Research Council
CollaboratorOTHER_GOV
Arthritis Research UK
CollaboratorOTHER
Royal College of Surgeons of Edinburgh
CollaboratorOTHER
University of Nottingham
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Brain activity related to temporal summation of pain in healthy individuals and OA patients using a novel fMRI cuff algometer.6 months post total knee replacement surgeryUsing 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

Secondary

MeasureTime frameDescription
Assessment of knee pain using the Visual Analogue Scale for Pain (0-10)6 months post total knee replacement surgeryPain using visual analogue scale
Assessment of improvement in the Oxford Knee Score6 months post total knee replacement surgerypain and function outcome measure
Assessment of change in healthy related quality of life measure using the EQ5D-5L questionnaire6 months post total knee replacementquality of life index measure

Countries

United Kingdom

Contacts

Primary ContactThomas Kurien, BMBS
thomas.kurien@nottingham.ac.uk
Backup ContactBrigitte E Scammell, FRCS
b.scammell@nottingham.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026