Plain English Summary
Background and study aims
Conditions of the musculoskeletal system, which affect joints, muscles ligaments and bones, are common and often painful. It is hugely frustrating for sufferers and can affect many aspects of their lives. We used to think that the pain was directly due to the pain signals from the joints or other tissues where the pain is being experienced. There is now evidence that this is not the only explanation for the pain and it may be related to changes in the chemical transmitters involved in the body’s pain detection system in the brain. Magnetic resonance imaging of the brain can be used to show how patients may have different brain responses to pain, even though their symptoms may be very similar. We will subgroup patients according to information about the symptoms that a patient is experiencing, as well as measurements of their pain thresholds as well as their brain-based responses to pain. In turn, this may help us to predict who will find one type of treatment more helpful than a different one. In the future, we hope that this will help more patients to manage their symptoms better.
Who can participate?
This study will focus on patients who have been diagnosed with either fibromyalgia or inflammatory arthritis and have been advised to start a new treatment by the doctors looking after them.
What does the study involve?
The study will follow patients for a period of 12 months after starting a new treatment (this may be a standard medication used for arthritis, or a programme of exercise combined with talking therapies). Many of the visits will be conducted alongside planned appointments at the hospital for their routine clinical care, but some extra research visits will take place in the research centre at the John Radcliffe Hospital where brain scans are done for research purposes.
What are the possible benefits and risks of participating?
Participants will not benefit directly from taking part in this study, but we hope that the information we get from this study will help to improve the treatment of musculoskeletal pain in the future.
Taking part in this study will require participants to attend the hospital for more visits than they would otherwise need. The sensory testing may cause minor, temporary discomfort but participants will be in control of the triggers applied and be free to stop the assessment at any
point in time.
MRI is safe and non-invasive and does not involve any ionising radiation (x-rays). However, because they use a large magnet to work, MRI scans are not suitable for everybody. Because of this, participants will be asked pre-screening safety questions to help determine if they are able to take part. Some people scanned in MRI scanners, especially 7 Tesla scanners, may experience a mild dizzy sensation as they are moved into the scanner. This is normal and the sensation starts to go away as soon as you are in the scanner. Occasionally a possible abnormality may be detected. In this case, we would have the scan checked by a doctor. If the doctor felt that the abnormality was medically important, the participant would be contacted directly and recommended to have a hospital (NHS) diagnostic scan arranged. All information is kept strictly confidential.
Where is the study run from?
Oxford University Hospital NHS Trust, Nuffield Orthopaedic Centre, Oxford
When is the study starting and how long is it expected to run for?
May 2019 to May 2020
Who is funding the study?
The University of Oxford
Who is the main contact?
Dr. Anushka Soni
anushka.soni@ndcn.ox.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Dr Anushka Soni
ORCID ID
http://orcid.org/0000-0002-7831-4208
Contact details
Botnar Research Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
01865 227374
anushka.soni@ndorms.ox.ac.uk
Type
Scientific
Additional contact
Dr Anushka Soni
ORCID ID
Contact details
Botnar Research Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
01865 227374
anushka.soni@ndorms.ox.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
IRAS Project ID 252762
Study information
Scientific title
Characterisation of pain in patients with musculoskeletal disease: a prospective, longitudinal, observational study.
Acronym
Study hypothesis
1. To investigate whether patients with inflammatory arthritis and features of centrally driven pain have reduced chance of responding to treatment.
2. To investigate the features of centrally driven pain, detected through multi-modal assessment, in patients with a range of musculoskeletal conditions
Ethics approval
Approved 05/04/2019, NHS HRA South Central - Oxford B REC (The Deanery, Christ Church, St Aldate's, Oxford, OX1 1DP; 02071048046; nrescommittee.southcentral-oxfordb@nhs.net), ref: 19/SC/0168.
Study design
Prospective observational longitudinal study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Musculoskeletal pain
Intervention
Observational study of treatment as usual for up to 12 months after initiation of treatment.
Assessments will include clinical history, disease activity score measures, questionnaire-based assessment of pain and related features, quantitative sensory testing and neuroimaging.
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
Percentage achieving Disease Activity Score <2.6, assessed using a combination of patient report and clinical assessment, 3 and 6 months after commencing treatment respectively.
Secondary outcome measures
Scoring according to: Central Sensitivity Inventory, Fibromyalgia survey criteria, PainDETECT questionnaire alongside neuroimaging findings, collected over a 12-month period.
Overall trial start date
08/08/2018
Overall trial end date
30/09/2024
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Participant is willing and able to give informed consent for participation in the study.
2. Clinical diagnosis of either inflammatory arthritis or fibromyalgia/chronic widespread pain
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Patients from vulnerable groups
2. Patients with a poor understanding of English
3. Patients with known neurological or psychiatric conditions (other than depression or anxiety) likely to independently affect the results of pain assessment, for example peripheral diabetic neuropathy in the opinion of the research team.
Recruitment start date
01/05/2019
Recruitment end date
01/05/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oxford University Hospital NHS Trust
Nuffield Orthopaedic Centre
Windmill Rd
Headington
Oxford
OX3 7HE
United Kingdom
Sponsor information
Organisation
University of Oxford
Sponsor details
Research Services
Clinical Trials and Research Governance
Joint Research Office
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7LQ
United Kingdom
000000000
ctrg@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Oxford
Alternative name(s)
Oxford University
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
We plan to publish the results in peer-reviewed journals and will also disseminate information directly to our study participants on completion of the analysis of the data collected. In addition, we will share the results of the study with the wider public through patient and public involvement initiatives organised by the University of Oxford.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.
Intention to publish date
01/09/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list