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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03126279
• Other study ID #: 10093
• Status: Recruiting
• Phase: N/A
• First received: April 11, 2017
• Last updated: April 21, 2017
• Start date: August 2015
• Est. completion date: August 2017

Study information

• Verified date: April 2017
• Source: University of Nottingham
• Contact: Thomas Kurien, BMBS
• Email: thomas.kurien[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Pain
• Pain, Postoperative
• Postoperative Pain
• Surgery

Intervention

Procedure:
• Total 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

Locations

Country	Name	City	State
United Kingdom	Academic Division of Trauma, Orthopaedics and Sports Medicine	Nottingham	Nottinghamshire

Sponsors (5)

Lead Sponsor	Collaborator
University of Nottingham	Aalborg University, Arthritis Research UK, Medical Research Council, Royal College of Surgeons of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Assessment of improvement in the Oxford Knee Score	pain and function outcome measure	6 months post total knee replacement surgery
Secondary	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