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
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
Approved 30/10/2018, London - West London & GTAC Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; 0207 104 8124; NRESCommittee.London-WestLondon@nhs.net), ref: 18/LO/1793
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
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