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

• Conditions: Postoperative Pain; Pain; Surgery; Osteoarthritis

• Registration Number: NCT03126279
• Lead Sponsor: University of Nottingham

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Status Verified: 2017-04
• Study First Submitted: 2017-04-11
• Study First Submitted QC: 2017-04-21
• Last Update Submitted: 2017-04-21
• Study First Posted: 2017-04-24
• Last Update Posted: 2017-04-24
• Primary Completion: 2017-06
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 surgery	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Academic Division of Trauma, Orthopaedics and Sports Medicine; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom