ISRCTN ISRCTN99466431
DOI https://doi.org/10.1186/ISRCTN99466431
Integrated Research Application System (IRAS) 353549
Funder reference number OBF/FR-000025814
Sponsor Keele University
Funders Nuffield Foundation, Versus Arthritis
Submission date
10/11/2025
Registration date
29/12/2025
Last edited
29/12/2025
Recruitment status
Not yet recruiting
Overall study status
Ongoing
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
The number of people who have pain, from conditions like arthritis and back pain, and experience its effect on daily activities, is higher in communities that can be considered to be underserved. These are communities that often experience more poverty and are more likely to include people from a range of ethnic backgrounds and cultures. Whilst these communities have the greatest need and impact on healthcare use, less is known about them because they have not participated or been included in previous research studies. This means that healthcare is being planned for them without good information about these communities. This project will collect information in underserved communities that will be used to understand why higher levels of pain and its impact on daily lives occur and how to work with people to reduce this.

Who can participate?
People living in underserved communities aged 35 years and over.

What does the study involve?
Participants will be asked to complete a questionnaire, and whether the information they provide can be linked with their health information. A small number of people from the communities will also be invited for more detailed information during interviews. The research team plans to work with people from underserved communities before the study, to help them ask the right questions and collect the best information. They will then work with people from underserved communities on how they can use the information to develop ways to reduce the number of people who experience pain and its impact in this community with the greatest need. The research team will also speak to government organisations and other people interested in improving health for people with musculoskeletal conditions (e.g. Versus Arthritis) to highlight their findings.

What are the possible benefits and risks of participating?
The information obtained from this study may help to provide new research evidence to inform efforts to reduce variation in musculoskeletal health at a population level. There may not be any immediate benefits for patients, although some people find it rewarding to take part in health research.
Participation in this study may help to:
• Improve NHS services that are provided for people with common musculoskeletal problems, such as back pain or osteoarthritis
• Understand the local need for treatment and which groups of people are most underserved by the NHS at present.

It is considered that there are minimal risks to participants associated with this study. One burden is the time it will take the participant to complete the survey. Participants are advised in the participant information leaflet of the time it will take to complete the survey. Participants who provide their personal details will also be assured in the leaflet that the information they provide will only be saved if they consent to take part in the study; otherwise, it will be deleted. Participants will also be advised about who will have access to the information they provide and how it will be used.

Where is the study run from?
Keele University, UK.

When is the study starting and how long is it expected to run for?
April 2026 to September 2028

Who is funding the study?
1. Arthritis UK (formerly Versus Arthritis).
2. The Nuffield Foundation, UK.

Who is the main contact?
Professor Ross Wilkie (CI), r.wilkie@keele.ac.uk
Clare Thompson (Trial Manager), c.thompson1@keele.ac.uk

Contact information

Prof Ross Wilkie
Public, Scientific, Principal investigator

University Road
Keele University
Keele, Staffordshire
ST5 5BG
United Kingdom

Phone +44 (0)1782734845
Email r.wilkie@keele.ac.uk
Mrs Clare Thompson
Public, Scientific

Keele University CTU
Keele University
Staffordshire
ST5 5BG
United Kingdom

ORCiD logoORCID ID 0009-0004-2160-0619
Phone +44 (0)1782 731428
Email c.thompson1@keele.ac.uk

Study information

Primary study designObservational
Study designMixed methods - a cross sectional face to face survey, with qualitative interviews including co-design and policy development
Secondary study designCross sectional study
Scientific titleMusculoskeletal conditions in underserved populations
Study acronymMSK UP
Study objectivesAim 1: To obtain person-centered data on musculoskeletal health, care and social determinants of health (SDOH) from underserved communities

Aim 2: To identify themes and inform a conceptual framework to understand intersectional social influences on musculoskeletal health and co-produce interventions to develop better treatment and prevention strategies to improve musculoskeletal health in underserved populations.

Aim 3: To create multi-level datasets through extensive linkage to primary and secondary care electronic medical records and aggregate-level data on SDOH.

Aim 4: Contribute to policy development and disseminate findings through working with local and national stakeholders
Ethics approval(s)

Not yet submitted

Health condition(s) or problem(s) studiedMusculoskeletal
InterventionCross-sectional face-to-face survey and qualitative interviews.

Participants will be approached at their homes and invited to complete a face-to-face survey on their doorstep. The survey will take no more than 20 minutes and will be administered by trained interviewers using a handheld tablet. Interviewers will first confirm eligibility, targeting adults aged 35 and over. Participants will be asked to provide informed consent for their survey responses to be linked to their medical records. This linkage will enable a follow-up review of their medical records, which will occur between one and two years after the initial survey completion.
Intervention typeOther
Primary outcome measure(s)
  1. High impact chronic pain measured using two single items that capture how often people have had pain in the previous 3 months (to identify chronicity) and how often did pain limits life or work activities (to capture impact) at baseline (survey administration)

-

Key secondary outcome measure(s)
  1. Chronic pain measured using one single item that captures how often people have had pain in the previous 3 months at baseline (survey administration)

-

Completion date30/09/2028

Eligibility

Participant type(s)Population
Age groupMixed
Lower age limit35 Years
Upper age limit99 Years
SexAll
Target sample size at registration2500
Key inclusion criteriaPeople aged 35 years and over and able to provide informed consent
Key exclusion criteria1. Has declined to be contacted about research studies recorded in their electronic health record
2. Patients receiving palliative care, patients residing in a nursing home, patients with severe mental illness and patients who are recently bereaved.
Date of first enrolment01/04/2026
Date of final enrolment01/10/2026

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

University of Keele
Keele
Newcastle Under Lyme
ST5 5BG
England

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Study website Study website 11/11/2025 11/11/2025 No Yes

Editorial Notes

11/11/2025: Study's existence confirmed by the Nuffield Foundation, UK.