Condition category
Musculoskeletal Diseases
Date applied
18/03/2019
Date assigned
19/06/2019
Last edited
19/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Publication citations

Additional files

Editorial Notes

18/06/2019: Trial’s existence confirmed by NHS HRA South Central - Oxford B REC.