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

April 21, 2017 updated by: University of Nottingham

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Recruiting
        • Academic Division of Trauma, Orthopaedics and Sports Medicine
        • Contact:
        • Sub-Investigator:
          • Thomas Kurien, MRCSEd
        • Sub-Investigator:
          • Brigitte E Scammell, FRCS
        • Principal Investigator:
          • Dorothee P Auer, PhD
        • Sub-Investigator:
          • Kristian K Petersen, PhD
        • Sub-Investigator:
          • Lars Ardent-Nielsen, PhD
        • Sub-Investigator:
          • Thomas Graven-Nieslen, PhD
        • Sub-Investigator:
          • David A Walsh, PhD
        • Sub-Investigator:
          • Robert W Kerslake, PhD
        • Sub-Investigator:
          • Diane Reckziegel, PhD
        • Sub-Investigator:
          • Sarina Iwabuchi, PhD
        • Sub-Investigator:
          • William J Cottam, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Other Names:
  • Total
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain activity related to temporal summation of pain in healthy individuals and OA patients using a novel fMRI cuff algometer.
Time Frame: 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
6 months post total knee replacement surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

Medical Research Council
Aalborg University
Arthritis Research UK
Royal College of Surgeons of Edinburgh

Investigators

  • Principal Investigator: Dorothee P Auer, PhD, The University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

April 11, 2017

First Submitted That Met QC Criteria

April 21, 2017

First Posted (Actual)

April 24, 2017

Study Record Updates

Last Update Posted (Actual)

April 24, 2017

Last Update Submitted That Met QC Criteria

April 21, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10093 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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