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

NCT ID: NCT03126279

Last Updated: 2017-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-08-31

Brief Summary

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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

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Conditions

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Osteoarthritis Pain Postoperative Pain Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Preoperative Chronic Knee OA Patients

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

Total Knee Replacement Surgery

Intervention Type 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

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.

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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Total

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aalborg University

OTHER

Sponsor Role collaborator

Medical Research Council

OTHER_GOV

Sponsor Role collaborator

Arthritis Research UK

OTHER

Sponsor Role collaborator

Royal College of Surgeons of Edinburgh

OTHER

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dorothee P Auer, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Nottingham

Locations

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Academic Division of Trauma, Orthopaedics and Sports Medicine

Nottingham, Nottinghamshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Thomas Kurien, BMBS

Role: CONTACT

Brigitte E Scammell, FRCS

Role: CONTACT

Facility Contacts

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Thomas Kurien, MRCSEd

Role: primary

Other Identifiers

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10093

Identifier Type: -

Identifier Source: org_study_id

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