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

• Conditions: Postoperative Pain; Pain; Surgery; Osteoarthritis
• Interventions: Procedure: Total Knee Replacement Surgery

• 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

Arm && Interventions

Group	Intervention	Description
Preoperative Chronic Knee OA Patients	Total Knee Replacement Surgery	Patients will be recruited from orthopaedic preoperative clinics from those awaiting total knee replacement surgery.

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