'Real world' pain outcomes and experiences of care for patients with musculoskeletal conditions in general practice (the MIDAS-GP study)
| ISRCTN | ISRCTN18132064 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18132064 |
| IRAS number | 292109 |
| Secondary identifying numbers | RG-0327-21, IRAS 292109 |
- Submission date
- 13/05/2021
- Registration date
- 25/06/2021
- Last edited
- 06/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims:
Painful musculoskeletal conditions like back pain and osteoarthritis cause more disability in the general population than any other health conditions. Poorer communities and individuals appear to be the hardest hit. In order to have a suitably ‘joined up’ response to this challenge we need accurate and meaningful joined-up information on musculoskeletal health, risk, and care in local populations.
The study aims to provide new research evidence to find out how to improve treatment for different groups of people with painful musculoskeletal conditions and between different general practices.
Who can participate?
Adults patients who have recently consulted their general practice with a painful musculoskeletal condition.
What does the study involve?
Patients who have recently consulted their general practice with a musculoskeletal condition will be invited to complete an initial pen-and-paper questionnaire or online questionnaire. Those who agree to take part will be asked to complete a follow-up questionnaire (either pen-and-paper or online questionnaire) after 3 and 6 months and one follow-up question (either pen-and-paper questionnaire or by SMS text message) about pain intensity after 1, 2, 4, and 5 months. A number of measurements will be taken including Musculoskeletal Health Questionnaire, Pain intensity (0-10 Scale) and Work productivity and activity impairment (WPAI). Participants will be asked if they give permission for their questionnaire responses to be linked with information held in their medical records to enable the type of care people are receiving with the kind of problem they have and the outcome of their care to be pieced together.
What are the possible benefits and risks of participating?
Although there is no immediate direct benefit, some people find it rewarding to take part in health research. Participants in this study will help to support how doctors and physiotherapists treat people with musculoskeletal symptoms involving back, neck, joint or muscle pain and understand the local need for treatment and which groups of people are most under-served by the NHS at present.
There are no risks involved in participating in this study and the care participants receive from their general practice will not be affected whether they take part or not. There is a time burden of answering the questions which are estimated to take about 15-20 minutes for each questionnaire.
Where is the study run from?
Keele University (UK)
When is the study starting and how long is it expected to run for?
From October 2020 to March 2025.
Who is funding the study?
The Nuffield Foundation (UK) and Versus Arthritis (UK)
Who is the main contact?
Clare Thompson
c.thompson1@keele.ac.uk
Contact information
Scientific
Primary Care Centre Versus Arthritis
School of Medicine
Keele University
Keele
Staffordshire
ST5 5BG
United Kingdom
 ORCID ID |
0000-0002-9008-0184 |
|---|---|
| Phone | +44 (0)1782 733906 |
| g.m.peat@keele.ac.uk |
Public
Primary Care Centre Versus Arthritis
School of Medicine
Keele University
Keele
Staffordshire
ST5 5BG
United Kingdom
| Phone | +44 (0)1782 733900 |
|---|---|
| j.hill@keele.ac.uk |
Public
Keele Clinical Trials Unit
Keele University
Keele
ST5 5BG
United Kingdom
| Phone | +44 (0)1782 732950 |
|---|---|
| c.thompson1@keele.ac.uk |
Study information
| Study design | Observational prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | No participant information sheet available yet |
| Scientific title | 'Real world' pain outcomes and experiences of care (MIDAS-GP) |
| Study acronym | MIDAS-GP |
| Study objectives | By linking patient questionnaires, electronic medical record data and publicly available data on neighbourhood health, assets and deprivation and on healthcare service characteristics, multi-level data sets will be created on patient cohorts that enable a better understanding of variations in, and determinants of, musculoskeletal outcomes in adults presenting to primary care with a common painful MSK condition. The intention is for this to impact on decisions about what information may be most useful and how it might be collected, linked, analysed, and disseminated within routine care. |
| Ethics approval(s) | Approved 10/08/2021, Yorkshire & The Humber - Leeds West Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ; +44 (0)207 972 2504; leedswest.rec@hra.nhs.uk), ref: 21/YH/0178 |
| Health condition(s) or problem(s) studied | Common musculoskeletal conditions that involve pain |
| Intervention | Adults consulting their general practice with a painful musculoskeletal condition will be invited to answer some questions about their condition and their care either through an online questionnaire (with support over the telephone, if needed) or by pen-and-paper questionnaire. Those who agree to take part will be contacted again with short questionnaires at 3 and 6 months and a brief one-question update at 1, 2, 4, and 5 months, to show if they have got better. They will also be asked to provide permission to link their questionnaire responses with information held in their medical records so that this information can be pieced together to look at the type of care people are receiving with the kind of problem they have and the outcome of their care. To get a proper overview, a second part of this study will look at the overall levels of prescribing painkillers, referrals to hospital specialists, and other measures of musculoskeletal care for each general practice. |
| Intervention type | Other |
| Primary outcome measure | 1. Pain intensity measured using a 0-10 Number Rating Scale (NRS) at baseline, 1, 2, 3, 4, 5 and 6 months 2. Musculoskeletal pain measured using a Musculoskeletal Health Questionnaire (MSK-HQ) at baseline, 3, and 6 months |
| Secondary outcome measures | 1. Pain Intensity measured using the Pain Intensity and Interference PEG (Pain, Enjoyment, General Activity) scale at baseline, 3, and 6 months 2. High impact chronic pain measured using a questionnaire at baseline, 3, and 6 months 3. Work status, absenteeism, and productivity loss measured using a questionnaire at baseline, 3, and 6 months 4. Global perceived change measured using a questionnaire at baseline, 3, and 6 months 5. Patient experience measured using a questionnaire at baseline 6. Healthcare use measured using a questionnaire at baseline, 3, and 6 months |
| Overall study start date | 01/10/2020 |
| Completion date | 31/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1424 |
| Total final enrolment | 2009 |
| Key inclusion criteria | 1. Aged ≥18 years 2. Registered with a participating general practice during the study period 3. Consulting any primary healthcare professional in the general practice for painful, non-inflammatory musculoskeletal disorder during the study period (according to predefined SNOMED code lists) 4. Able to read/understand English with or without assistance (patient-report survey component only) 5. Able to provide informed consent (patient-report survey component only) |
| Key exclusion criteria | 1. Inflammatory musculoskeletal disease (according to predefined SNOMED code lists retrospectively examined over the previous 3 years) 2. Has indicated in the record that they do not consent to be approached about research studies |
| Date of first enrolment | 01/09/2021 |
| Date of final enrolment | 31/08/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Staffordshire
ST5 5BG
United Kingdom
Sponsor information
University/education
Directorate of Research, Innovation and Engagement
Innovation Centre 2
Staffordshire
ST5 5NH
England
United Kingdom
| Phone | +44 (0)1782 732975 |
|---|---|
| research.governance@keele.ac.uk | |
| Website | http://www.keele.ac.uk/ |
"ROR" |
https://ror.org/00340yn33 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- United Kingdom
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publications and dissemination in the following: 1. Written summary reports and data visualisations for participating GP practices and community musculoskeletal services 2. Press releases, briefings, articles, and interviews for local radio and newspapers 3. Presentations to stakeholder meetings 4. A study website, institutional websites, social media including Twitter, YouTube video 5. Links with key local, national and international organisations including Versus Arthritis, West Midlands Academic Health Science Network, Keele Deal: Health, Applied Research Collaboration, Public Health England, NICE, to contribute to and capitalise on their networks 6. Publications (to include PPIE co-authors) including full report, executive summary and plain English summary, peer-reviewed journals, and local NHS and research newsletters 7. Presentations at high-profile scientific and health policy conferences: NHS Evidence, Society for Academic Primary Care, Chartered Society of Physiotherapy, Public Health England |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from medicine.datasharing@keele.ac.uk. De-identified individual participant data will be available upon publication of main study findings or within 18 months of study completion (whichever is later) and with no end date. Data will be made available to bonafide researchers upon reasonable request for replication or new secondary analysis via our controlled access procedures and in accordance with Data Sharing Agreements. Consent for patient-reported outcomes/experiences data will be sought from patients; consent for EHR-only processes of care data will not be sought. Data will be anonymised. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 05/07/2021 | 13/10/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 3.0 | 03/10/2023 | 09/11/2023 | No | No |
| Other unpublished results | End of Research Summary Report to Research Ethics Committee version 1.0 |
13/01/2025 | 21/01/2025 | No | No |
| Plain English results | version 1.0 | 14/01/2025 | 27/01/2025 | No | Yes |
| Results article | 15/07/2025 | 16/07/2025 | Yes | No | |
| Protocol file | version 9.1 | 16/04/2025 | 06/08/2025 | No | No |
Additional files
- ISRCTN18132064_Protocol_v1.0_05Jul21.pdf
- ISRCTN18132064_PROTOCOL_V3.0_03Oct23.pdf
- ISRCTN18132064_Results_End_of_research_summary_report_V1.0_13Jan2025.pdf
- End of Research Summary Report to Research Ethics Committee
- ISRCTN18132064_ResultsPlainEnglish_v1.0_14Jan2025.pdf
- ISRCTN18132064_Protocol_v9.1_16April2025.pdf
Editorial Notes
06/08/2025: Protocol file version 9.1 uploaded.
16/07/2025: Publication reference added.
27/01/2025: Internal review.
21/01/2025: A lay summary of results and the final results report were uploaded.
09/11/2023: Protocol file uploaded. Total final enrolment added.
08/08/2022: The following updates have been made and the plain English summary updated accordingly:
1. The public contact was updated.
2. The recruitment end date has been changed from 30/09/2022 to 31/08/2022.
15/03/2022: The following changes have been made to the trial record:
1. The recruitment end date was changed from 30/03/2022 to 30/09/2022.
2. The target number of participants was changed from 1139 to 1424.
13/10/2021: The following changes have been made to the trial record:
1. The protocol (not peer reviewed) has been uploaded as an additional file.
2. The ethics approval has been added.
21/09/2021: The recruitment end date has been changed from 30/09/2021 to 30/03/2022.
20/07/2021: The recruitment start date was changed from 01/07/2021 to 01/09/2021.
01/07/2021: A public contact has been added.
10/06/2021: Trial’s existence confirmed by Nuffield Foundation.
