Stepping up the evidence for musculoskeletal services

ISRCTN	ISRCTN23378642
DOI	https://doi.org/10.1186/ISRCTN23378642
Protocol serial number	14803
Sponsor	Keele University (UK)
Funder	Chartered Society of Physiotherapy Charitable Trust (UK)

Submission date: 05/07/2013
Registration date: 05/07/2013
Last edited: 14/03/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
This study is evaluating local NHS services for patients with pain conditions. Aches and pains are very common symptoms. The study aims to find out more about patients with pain or pain-related symptoms and the services available to them.

Who can participate?
Patients aged 18 or over seeing a GP with a pain or pain-related problem and who are registered at one of the four participating GP practices will be invited to take part in the study.

What does the study involve?
It involves completion of four questionnaires in total over a period of 12 months and a medical record review, where a researcher will collect information from the patient's medical records about their pain or related symptoms over the 12 months of the study.

What are the possible benefits and risks of participating?
We do not expect any problems for patients from taking part in this study and although there is no direct benefit from taking part, what we learn from the study should help to develop better services for patients with pain and pain-related symptoms in the future.

Where is the study run from?
The study is run by a research team based at the Arthritis Research UK Primary Care Centre at Keele University, UK.

When is the study starting and how long is it expected to run for?
Recruitment began in early June 2013 and is expected to be completed by January 2014. Follow-up of participants will continue until January 2015.

Who is funding the study?
Charitable Trust of the Chartered Society of Physiotherapy (CSP) (UK)

Who is the main contact?
Stephanie Tooth
Tel: 01782 734835
s.j.tooth@keele.ac.uk

Contact information

Prof Nadine Foster
Scientific

Primary Care Sciences Research Centre
Keele
Newcastle
ST5 5BG
United Kingdom

Email	n.foster@keele.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Not specified
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	STEMS study: STepping up the Evidence for Musculoskeletal Services: a pilot cluster randomised controlled trial
Study acronym	STEMS
Study objectives	Musculoskeletal problems are common and costly, leading to 9.3 million lost working days in the UK per year. The most common presentations include low back pain, shoulder pain, neck pain, knee pain and widespread pain where many sufferers develop persistent or recurrent problems. Given our ageing population and the impact of these problems, the demand for musculoskeletal healthcare is set to rise. For most patients in the UK, the first professional seen is the GP and access to NHS physiotherapy is controlled through GP referral. For example approximately 1.3 million of all consultations for low back pain in UK general practice are referred onwards to physiotherapists. This pilot randomised controlled cluster trial will test the addition of a self-referral to physiotherapy pathway to usual GP-led care. Self-referral is a system of access in which patients are able to refer themselves to a physiotherapist directly without having to see anyone else first or without being told to refer themselves by a doctor. All patients in the trial (intervention and control) will receive care for their musculoskeletal condition as indicated by their clinical need and as directed by their health care professionals, but patients in the intervention practices will have the option to self-refer to physiotherapy. We aim to recruit for a 6 month period estimating that around 960 participants will be recruited. Participants will complete questionnaires at baseline, 2, 6 and 12 months providing information about their musculoskeletal condition, the care received for the condition and clinical and cost outcomes.
Ethics approval(s)	First MREC approval date 08/02/2013, ref: 13/NW/0053
Health condition(s) or problem(s) studied	Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases
Intervention	Self referral physio pathway. The intervention is the addition of a self-referral to physiotherapy pathway to usual GP-led care for patients with a musculoskeletal condition Study Entry: Single Randomisation only
Intervention type	Other
Primary outcome measure(s)	Physical function, measured by Version 2.0 of SF-36 Health Survey Scoring Demonstration (SF36v2) physical component summary at baseline, 2, 6 and 12 months follow-up
Key secondary outcome measure(s)	1. Accessibility of services; Timepoint(s): 2 and 6 months 2. Baseline risk of persistent problems; Timepoint(s): Baseline only 3. Comorbidities; Timepoint(s): Baseline only 4. Demographics; Timepoint(s): Baseline only 5. Experience of consultations; Timepoint(s): Baseline, 2 and 6 months 6. Further health care utilisation; Timepoint(s): 2 and 6 months 7. Mental health; SF36v2 Mental Component Summary; Timepoint(s): baseline, 2, 6 and 12 months 8. Overall change in condition; Global Assessment of Change one question; Timepoint(s): 2, 6 and 12 months 9. Pain duration; Timepoint(s): Baseline only 10. Pain location; Timepoint(s): Baseline only 11. Presenteeism; Timepoint(s): Baseline, 2, 6 and 12 months 12. Quality of Life; Timepoint(s): Baseline, 2, 6 and 12 months 13. Satisfaction with services; Timepoint(s): 2 and 6 months 14. Self-efficacy; Timepoint(s): Baseline, 2, 6 and 12 months 15. Understanding of condition; Timepoint(s): Baseline, 2, 6 and 12 months 16. Willingness to pay; Timepoint(s): 12 months only 17. Work absence; Timepoint(s): Baseline, 2, 6 and 12 months
Completion date	31/12/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	960
Key inclusion criteria	Adults consulting participating GP practices or physiotherapy services with musculoskeletal problems (for either their first consultation for a new episode of musculoskeletal pain or a reconsultation) Target Gender: Male & Female ; Lower Age Limit 18 years
Key exclusion criteria	1. Under 18 years old 2. Those consulting with nonmusculoskeletal problems 3. Those unable to provide their own consent to the research evaluation 4. Those undergoing palliative care 5. Those with severe learning disabilities or are housebound or are in nursing home accommodation 6. Those unable to communicate in English
Date of first enrolment	10/06/2013
Date of final enrolment	31/12/2014

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Keele University

Newcastle
ST5 5BG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	12/03/2017		Yes	No
Protocol article	protocol	01/12/2015		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/03/2017: Publication reference added.