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

NCT03126279 | Unknown

• 1 other identifier: 10093
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis; Pain; Postoperative Pain; Surgery

Keywords

Osteoarthritis; Pain; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assessment of knee pain using the Visual Analogue Scale for Pain (0-10)

  6 months post total knee replacement surgery

• Assessment of improvement in the Oxford Knee Score

  6 months post total knee replacement surgery

• Assessment of change in healthy related quality of life measure using the EQ5D-5L questionnaire

  6 months post total knee replacement

Study Arms (2)

Preoperative Chronic Knee OA Patients

Patients will be recruited from orthopaedic preoperative clinics from those awaiting total knee replacement surgery.

Procedure: Total Knee Replacement Surgery

Healthy Volunteers

Healthy volunteers will be recruited that are aged match to our OA patient cohort so meaningful comparisons regarding brain activity and pain sensitisation characteristics can be assessed.

Interventions

Total Knee Replacement Surgery PROCEDURE

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

Also known as: Total

Preoperative Chronic Knee OA Patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead
• Aalborg University: collaborator
• Medical Research Council: collaborator
• Arthritis Research UK: collaborator
• Royal College of Surgeons of Edinburgh: collaborator

Study Sites (1)

Academic Division of Trauma, Orthopaedics and Sports Medicine

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Dorothee P Auer, PhD

  The University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Kurien, BMBS

CONTACT

thomas.kurien@nottingham.ac.uk

Brigitte E Scammell, FRCS

CONTACT

b.scammell@nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 24, 2017
• Study Start: August 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 24, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)