Condition category
Musculoskeletal Diseases
Date applied
04/09/2018
Date assigned
11/09/2018
Last edited
11/09/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In the UK 3.2 million working days are lost annually due to 30% of adults experiencing low back pain at any one time. 20% of individuals with low back pain seek care from their GP, representing 7% of all GP consultations. Early assessment and management of low back pain is important to reduce long-term pain and disability. Currently, there are too few GPs to meet the demands of the British public, with numbers predicted to fall further by 2020. To help combat this shortage, a range of organisations including the British Medical Association and the Chartered Society of Physiotherapy have committed to enabling direct access to physiotherapists in their local health centre without having to see a GP first for problems such as low back pain. It is envisaged that Advanced Physiotherapy Practitioners (APPs) working in these roles will prescribe medicines such as painkillers as part of a holistic treatment strategy to get patients managing their back pain as quickly and as best as possible. Physiotherapist prescribing remains novel, with the first prescribers qualifying in 2013. The true benefits now need to be evaluated, to do this we need to complete a clinical trial. To ensure that we are able to complete a trial of worth, we are first completing a feasibility trial.

Who can participate?
Patients aged 18 and over with low back pain

What does the study involve?
As per current normal practice, an APP completes the initial assessment and physiotherapeutic treatment of participants as deemed appropriate (traditional role). In addition to the physiotherapist’s traditional role, the APP can prescribe medicines independently. If advice about medication or prescription drugs are required/no longer required, these are prescribed/de-prescribed by the APP immediately, rather than referring the patient back to their GP for assessment for medications as per current normal practice. The medications provided should be taken by the patient as prescribed in the time frames discussed in the clinical consultation. Following initial assessment by a physiotherapist the participants are required to complete online questionnaires at 6 and 12 weeks. The trial explores the measures used to assess outcomes from treatment by using questionnaires and small devices call accelerometers (like 'fitbits') which assess how active or still people are during the day. The trial also explores how patients and physiotherapists involved found taking part via focus groups and interviews.

What are the possible benefits and risks of participating?
It is anticipated that the results of this trial will be used to help design a full trial. The information participants provide may help them and other patients in the future. It will not change the treatment that they receive for their back pain. There are no anticipated risks associated with undertaking this study and the only cost to the participant(s) is the time involved with completing the questionnaire and (for some people) attending a focus group. Participation in this study is entirely voluntary. It is possible that when talking about a participants back pain or filling in the questionnaire participants may be asked to relive events which are emotional for them. However, every effort will be made to ensure that participants are comfortable at all times.

Where is the study run from?
1. Guys and St Thomas' NHS Foundation Trust (UK)
2. Windermere Health Centre & Ambleside Health Centre (UK)
3. Sheffield Teaching Hospitals NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
May 2018 to December 2019

Who is funding the study?
1. Health Education England (UK)
2. Private Physiotherapy Education Fund (UK)

Who is the main contact?
Mr Timothy Noblet

Trial website

Contact information

Type

Public

Primary contact

Mr Timothy Noblet

ORCID ID

Contact details

Centre of Precision Rehabilitation Spinal Pain
School of Sport
exercise and Rehabilitation Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RG_18-101

Study information

Scientific title

Independent prescribing by advanced physiotherapists for patients with low back pain in primary care: a feasibility trial with an embedded qualitative component

Acronym

Study hypothesis

Aim: To evaluate the feasibility, suitability and acceptability of assessing the effectiveness of independent prescribing by advanced physiotherapy practitioners (APPs) for patients with LBP in primary care, to inform the design of a future definitive stepped-wedged cluster trial.

Ethics approval

Not provided at time of registration

Study design

The feasibility trial will utilise a mixed-methods research approach, comprising of:
1. A quantitative one-armed feasibility trial
2. Qualitative semi-structured interviews and patient focus groups, using thematic analysis

Primary study design

Interventional

Secondary study design

Feasibility trial with an embedded qualitative component

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Low back pain

Intervention

Randomisation will not occur in this feasibility trial as the aim is to test the methods etc. The feasibility trial will use the proposed experimental arm for the full study to test the feasibility of the methods, outcome measures, analysis and synthesis. The control arm of the definitive trial will be current normal practice. As per current normal practice, an APP acting as a FCP will complete the initial assessment and physiotherapeutic treatment of participants as deemed appropriate through evidence based clinical reasoning and best practice (traditional role). In addition to the physiotherapist’s traditional role, the APP will have the competence and legal ability to prescribe medicines independently. If advice about medication or prescription drugs are required/no longer required within the multi-modal physiotherapeutic context, these will be prescribed/de-prescribed by the APP immediately, rather than referring the patient back to their GP for assessment for medications as per current normal practice. The medications provided should be taken by the patient as prescribed in the time frames discussed in the clinical consultation. Following initial assessment by a physiotherapist the participants will be required to complete online outcome measurement questionnaires at 6 and 12 weeks.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Measured at 6 and 12 weeks:
1. Overall pain, measured using the Numerical Rating Scale (NRS)
2. Disability, assessed using the Roland Morris Disability Questionnaire (RMDQ)

Secondary outcome measures

Measured at 6 and 12 weeks:
1. Health-related quality of life, measured using EQ5D
2. Kinesiophobia, measured using the Tampa scale
3. Physical activity/sedentary behaviour, measured using accelerometers
4. Sleep, measured using accelerometers
5. Return to work (days)
6. Prescription utilisation (number of occasions)
7. Number of appointments with other healthcare professionals about this episode of LBP

Overall trial start date

01/05/2018

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male and female patients, aged >18 years
2. Non-specific LBP +/- leg pain requiring medication advice and drug prescription on assessment
3. Classified as Moderate risk using the STarT Back Tool (classified as potentially benefiting from medicines and active physiotherapy treatment)
4. Able to read/communicate in English (due to funding restrictions for interpreters and translators limited in the inclusion of participant speaking other languages)
5. Capable of following the demands inherent of the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Signs of lumbar nerve root compression
2. Red Flags including potential spinal fracture, inflammatory disease, infection or malignancy
3. Spinal stenosis
4. Suspicion of or confirmed corda equine syndrome
5. Does not have capacity to consent

Recruitment start date

01/10/2018

Recruitment end date

10/04/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guys and St Thomas' NHS Foundation Trust
London
SE1 9RT
United Kingdom

Trial participating centre

Windermere Health Centre & Ambleside Health Centre
Cumbria
LA23 2EG
United Kingdom

Trial participating centre

Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
S5 7AT
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

Edgbaston Park Road
Birmingham
B15 3TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health Education England

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Private Physiotherapy Education Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The dissemination strategy is multi-faceted in order to achieve maximum awareness and impact, and therefore potential change to NHS perceptions, current management strategies and service delivery in the longer term.

Professional dissemination:
1. A study report will be submitted to the funders and ethics committees
2. The Investigators will rapidly disseminate (oral presentation, email, social media) key findings to their clinical colleagues in the NHS and HEE in preparation for a full cRCT
3. The findings will be presented in an article that will be submitted to a high impact open access journal, accessible to UK and international professionals, targeting Plos One
4. Findings will be presented at Physiotherapy UK, and WCPT to target physiotherapists nationally and internationally

Patient/user dissemination:
1. A lay summary of the report will be written for patients
2. All study participants will receive a copy of the lay summary of findings
3. The source of funding will be acknowledged in all dissemination. Dissemination of findings will ensure confidentiality to participants

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

01/01/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes