Musculoskeletal DiseasesNCT05842915
The National Musculoskeletal Audit and Research Database
An observational study of Musculoskeletal Diseases, run by Keele University at 1 site in United Kingdom.
Trial summary
Developing and testing a musculoskeletal national audit in community/primary care Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 22,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 May 2024to 7 Jun 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 22,000 adult patients (over 2-year period), aged 18+ years consulting a) a Community MSK Service or b) a First Contact Practitioner (FCP) service in primary care, for a musculoskeletal pain condition
Who may be able to join
- (MSK Services)
- MSK service seeing adult (+18 years) set in community care
- MSK service with at least 10 WTE HCPs
- System in place for digital collection of PROM/PREM data
- (FCP Services)
- FCP service seeing adult (+18 years) in primary care
Show all 14Show fewer
- FCP service with at least 1 WTE FCP seeing MSK patients
- Use of EMIS or SYSTMONE
- Able to implement Midlands FCP template
- System in place for digital collection of PROM/PREM data
- (For patients)
- +18 years
- Active phone number or verified email address to participate in the patient questionnaire
- Able to provide informed consent
Who cannot join
- (MSK Services)
- Secondary care MSK services
- (For patients)
- Has declined for data to be part of research as part of consent process
- Unable to complete surveys due to health issues including severe or terminal illness, severe learning difficulties or psychological disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Keele University
Keele, Staffordshire, ST5 5BG
Roanna Burgess, Dr, 01782 733900, r.m.burgess@keele.ac.uk
Jonathan Hill, Prof, 01782 733900, j.hill@keele.ac.uk
About this study
Official title: Developing and Testing a Musculoskeletal National Audit in Community/Primary Care
Developing and testing a musculoskeletal national audit in community/primary care
Read the detailed description
This project aims to develop, setup and test an MSK national audit which will use patient and clinician inputted data to measure the quality of care for patients presenting in community MSK services and general practice with common MSK conditions. Secondly this project aims to use the national MSK audit information to understand and improve the quality and consistency of care for MSK patients.
- Conditions
- Musculoskeletal Diseases
- Being tested
- Questionnaire
- Keywords
- Primary Care, Community, Benchmarking, Audit, Quality Improvement
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Baseline and 3 month questionnaire
| Study group | Role | What they receive |
|---|---|---|
| First Contact Practitioner (FCP) | A continuous routine-data cohort study involving FCP primary care services aiming to recruit a minimum of 25patients per service from 10 FCP services, with complete data from at least 25 patients at baseline and 3-month follow up per service for each 12-month period. Data collection will involve:
Patient survey (to collect outcomes and experiences)
Organisational characteristics (collected via a survey to service leads and via publicly available national sources)
Electronic health record (EHR) data (collected via a standardised FCP template and search within EHR systems) Receives: Behavioral: Questionnaire | |
| MSK Community Services | A continuous routine-data cohort study involving MSK Community Services, aiming to recruit a minimum of 250 patients per service from a minimum of 10 MSK services, with complete data from at least 250 patients at baseline and 3-month follow up per service for each 12-month period. Data collection will involve:
Patient survey (to collect outcomes and experiences)
Organisational characteristics (collected via a survey to service leads and via publicly available national sources) Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide a secure national MSK research database for participating MSK providers to upload their routinely collected data.
Measured: 12 months
Secondary outcomes (1)
To develop a standard dashboard and reporting system that supports an ongoing automated process to analyse and present the data for quality improvement purposes.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start7 May 2024
- Primary completion7 Jun 2028 (estimated)
- Study completion7 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 22,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Keele University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842915
- Sponsor's protocol ID
- RG-0359-22
- Status last verified
- Feb 2026
- First submitted
- 24 Apr 2023
- Last updated
- 5 Feb 2026
- 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 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Musculoskeletal National Audit in Community/Primary Care
- ClinicalTrials.gov ID
- NCT05842915
- Acronym / sponsor ID
- RG-0359-22
- Conditions
- Musculoskeletal Diseases
- Keywords
- Primary Care, Community, Benchmarking, Audit, Quality Improvement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 22,000 participants (estimated)
- Lead sponsor
- Keele UniversityUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 7 Jun 2028 (estimated)
- Study completion
- 7 Jun 2028 (estimated)
- First posted
- 6 May 2023 (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.
Developing and testing a musculoskeletal national audit in community/primary care
Detailed description
This project aims to develop, setup and test an MSK national audit which will use patient and clinician inputted data to measure the quality of care for patients presenting in community MSK services and general practice with common MSK conditions. Secondly this project aims to use the national MSK audit information to understand and improve the quality and consistency of care for MSK patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Contact Practitioner (FCP) | – | Behavioral: QuestionnaireA continuous routine-data cohort study involving FCP primary care services aiming to recruit a minimum of 25patients per service from 10 FCP services, with complete data from at least 25 patients at baseline and 3-month follow up per service for each 12-month period. Data collection will involve: Patient survey (to collect outcomes and experiences) Organisational characteristics (collected via a survey to service leads and via publicly available national sources) Electronic health record (EHR) data (collected via a standardised FCP template and search within EHR systems) |
| MSK Community Services | – | Behavioral: QuestionnaireA continuous routine-data cohort study involving MSK Community Services, aiming to recruit a minimum of 250 patients per service from a minimum of 10 MSK services, with complete data from at least 250 patients at baseline and 3-month follow up per service for each 12-month period. Data collection will involve: Patient survey (to collect outcomes and experiences) Organisational characteristics (collected via a survey to service leads and via publicly available national sources) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 22,000 adult patients (over 2-year period), aged 18+ years consulting a) a Community MSK Service or b) a First Contact Practitioner (FCP) service in primary care, for a musculoskeletal pain condition
Key inclusion criteria (14 listed)
- (MSK Services)
- MSK service seeing adult (+18 years) set in community care
- MSK service with at least 10 WTE HCPs
- System in place for digital collection of PROM/PREM data
- (FCP Services)
Key exclusion criteria (5 listed)
- (MSK Services)
- Secondary care MSK services
- (For patients)
- Has declined for data to be part of research as part of consent process
- Unable to complete surveys due to health issues including severe or terminal illness, severe learning difficulties or psychological disorders
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 |
|---|---|---|
| QuestionnaireBaseline and 3 month questionnaire | Behavioural | First Contact Practitioner (FCP), MSK Community Services |
Primary outcome
To provide a secure national MSK research database for participating MSK providers to upload their routinely collected data.
Time frame: 12 months
1 secondary outcome
To develop a standard dashboard and reporting system that supports an ongoing automated process to analyse and present the data for quality improvement purposes.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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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.
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 Musculoskeletal Diseases, run by Keele University 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 14 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roanna Burgess, Dr (01782733900, r.m.burgess@keele.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To provide a secure national MSK research database for participating MSK providers to upload their routinely collected data. (time frame: 12 months). 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 5 Feb 2026.