Condition category
Musculoskeletal Diseases
Date applied
05/07/2013
Date assigned
05/07/2013
Last edited
17/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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?
The study has been funded by the 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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Nadine Foster

ORCID ID

Contact details

Primary Care Sciences Research Centre
Keele
Newcastle
ST5 5BG
United Kingdom
-
n.foster@keele.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14803

Study information

Scientific title

STEMS study: STepping up the Evidence for Musculoskeletal Services: a pilot cluster randomised controlled trial

Acronym

STEMS

Study hypothesis

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

13/NW/0053; First MREC approval date 08/02/2013

Study design

Randomised; Interventional; Design type: Not specified

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase III

Drug names

Primary outcome measures

Physical function: measured by Version 2.0 of SF-36 Health Survey Scoring Demonstration (SF36v2) physical component summary over baseline, 2 month, 6 month and 12 month follow-up

Secondary outcome measures

1. Accessibility of services; Timepoint(s): 2 month and 6 month
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 month and 6 months
6. Further health care utilisation; Timepoint(s): 6 month and 2 month
7. Mental health; Timepoint(s): SF36v2 Mental Component Summary - baseline, 2 month, 6 month and 12 month
8. Overall change in condition; Timepoint(s): Global Assessment of Change one question, at 2 month, 6 month and 12 months
9. Pain duration; Timepoint(s): Baseline only
10. Pain location; Timepoint(s): Baseline only
11. Presenteeism; Timepoint(s): Baseline, 2 month, 6 month and 12 month
12. Quality of Life; Timepoint(s): Baseline, 2 month, 6 month, 12 month
13. Satisfaction with services; Timepoint(s): 2 month and 6 month
14. Self-efficacy; Timepoint(s): Baseline, 2 month, 6 month and 12 month
15. Understanding of condition; Timepoint(s): Baseline, 2 month, 6 month and 12 month
16. Willingness To Pay; Timepoint(s): 12 month only
17. Work absence; Timepoint(s): Baseline, 2 month, 6 month and 12 month

Overall trial start date

10/06/2013

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 960; UK Sample Size: 960

Participant 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

Recruitment start date

10/06/2013

Recruitment end date

31/12/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Care Sciences Research Centre
Newcastle
ST5 5BG
United Kingdom

Sponsor information

Organisation

Keele University (UK)

Sponsor details

Keele
Newcastle
ST5 5BG
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Chartered Society of Physiotherapy Charitable Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.pilotfeasibilitystudies.com/content/1/1/26

Publication citations

Additional files

Editorial Notes