OsteoarthritisNCT03126279
fMRI and Central Sensitization in Chronic Knee Osteoarthritis. A Pre and Post TKR Study
An observational study of Osteoarthritis and Pain, run by University of Nottingham at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Pain, Postoperative Pain
- What is being tested?
- Total Knee Replacement Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -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
Trial locations and contacts
1 site in 1 country.
Thomas Kurien, BMBS contact
Brigitte E Scammell, FRCS contact
United Kingdom1 site, 1 recruiting
- Recruiting
Academic Division of Trauma, Orthopaedics and Sports Medicine
Nottingham, Nottinghamshire, NG7 2UH
Thomas Kurien, MRCSEd, thomas.kurien@nottingham.ac.uk
Thomas Kurien, MRCSEd
About this study
Official title: 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
- Conditions
- Osteoarthritis, Pain, Postoperative Pain, Surgery
- Being tested
- Total Knee Replacement Surgery
- Keywords
- Osteoarthritis, Pain, Postoperative Pain
- Medical subject headings
- Osteoarthritis, Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee Replacement SurgeryProcedure or surgery
Also called Total
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
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Chronic Knee OA Patients | Patients will be recruited from orthopaedic preoperative clinics from those awaiting total knee replacement surgery. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months post total knee replacement surgery
Secondary outcomes (3)
Assessment of knee pain using the Visual Analogue Scale for Pain (0-10)
Pain using visual analogue scale
Measured: 6 months post total knee replacement surgery
Assessment of improvement in the Oxford Knee Score
pain and function outcome measure
Measured: 6 months post total knee replacement surgery
Assessment of change in healthy related quality of life measure using the EQ5D-5L questionnaire
quality of life index measure
Measured: 6 months post total knee replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study startAug 2015
- Primary completionJun 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University, Medical Research Council, Arthritis Research UK, Royal College of Surgeons of Edinburgh
- Responsible party
- Sponsor
- Investigators
- Dorothee P Auer, PhD, Principal investigator, The University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126279
- Sponsor's protocol ID
- 10093
- Status last verified
- Apr 2017
- First submitted
- 11 Apr 2017
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Chronic Post TKR Pain by Assessing Central Sensitisation Using Functional Brain MRI
- ClinicalTrials.gov ID
- NCT03126279
- Acronym / sponsor ID
- 10093
- Conditions
- Osteoarthritis, Pain, Postoperative Pain, Surgery
- Keywords
- Osteoarthritis, Pain, Postoperative Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Aalborg University, Medical Research Council, Arthritis Research UK, Royal College of Surgeons of Edinburgh
- Study start
- Aug 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative Chronic Knee OA Patients | – | Procedure: Total Knee Replacement SurgeryPatients will be recruited from orthopaedic preoperative clinics from those awaiting 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Knee Replacement SurgeryAlso: TotalAll 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 | Procedure or surgery | Preoperative Chronic Knee OA Patients |
Primary outcome
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
3 secondary outcomes
Assessment of knee pain using the Visual Analogue Scale for Pain (0-10)
Time frame: 6 months post total knee replacement surgery
Assessment of improvement in the Oxford Knee Score
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Kurien, BMBS contact
Brigitte E Scammell, FRCS contact
Dorothee P Auer, PhD principal investigator
The University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Pain, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Kurien, BMBS (thomas.kurien@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.