Feasibility of delivering and evaluating stratified care integrated with telehealth (‘Rapid Stratified Telehealth’) for patients with low back pain: protocol for a feasibility and pilot randomised controlled trial

IntroductionLong waiting time is an important barrier to accessing recommended care for low back pain (LBP) in Australia’s public health system. This study describes the protocol for a randomised controlled trial (RCT) that aims to establish the feasibility of delivering and evaluating stratified care integrated with telehealth (‘Rapid Stratified Telehealth’), which aims to reduce waiting times for LBP.Methods and analysisWe will conduct a single-centre feasibility and pilot RCT with nested qualitative interviews. Sixty participants with LBP newly referred to a hospital outpatient clinic will be randomised to receive Rapid Stratified Telehealth or usual care. Rapid Stratified Telehealth involves matching the mode and type of care to participants’ risk of persistent disabling pain (using the Keele STarT MSK Tool) and presence of potential radiculopathy. ‘Low risk’ patients are matched to one session of advice over the telephone, ‘medium risk’ to telehealth physiotherapy plus App-based exercises, ‘high risk’ to telehealth physiotherapy, App-based exercises, and an online pain education programme, and ‘potential radiculopathy’ fast tracked to usual in-person care. Primary outcomes include the feasibility of delivering Rapid Stratified Telehealth (ie, acceptability assessed through interviews with clinicians and patients, intervention fidelity, appointment duration, App useability and online pain education programme usage) and evaluating Rapid Stratified Telehealth in a future trial (ie, recruitment rates, consent rates, lost to follow-up and missing data). Secondary outcomes include waiting times, number of appointments, intervention and healthcare costs, clinical outcomes (pain, function, quality of life, satisfaction), healthcare use and adverse events (AEs). Quantitative analyses will be descriptive and inform a future adequately-powered RCT. Interview data will be analysed using thematic analysis.Ethics and disseminationThis study has received approval from the Ethics Review Committee (RPAH Zone: X21-0221). Results will be published in peer-reviewed journals and presented at conferences.Trial registration numberACTRN12621001104842.

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Effectiveness and cost-effectiveness of a progressive, individualised walking and education programme for prevention of low back pain recurrence in adults: study protocol for the WalkBack randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-037149 ◽

2020 ◽

Vol 10 (10) ◽

pp. e037149

Author(s):

Natasha Celeste Pocovi ◽

Chung-Wei C Lin ◽

Jane Latimer ◽

Dafna Merom ◽

Anne Tiedemann ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Education Programme ◽

Current Evidence ◽

Low Back ◽

Treatment Control ◽

Randomised Controlled

IntroductionLow back pain (LBP) is recognised globally as a prevalent, costly and disabling condition. Recurrences are common and contribute to much of the burden of LBP. Current evidence favours exercise and education for prevention of LBP recurrence, but an optimal intervention has not yet been established. Walking is a simple, widely accessible, low-cost intervention that has yet to be evaluated. This randomised controlled trial (RCT) aims to establish the effectiveness and cost-effectiveness of a progressive and individualised walking and education programme (intervention) for the prevention of LBP recurrences in adults compared with no treatment (control).Methods and analysisA pragmatic, two-armed RCT comparing walking and education (n=349) with a no treatment control group (n=349). Inclusion criteria are adults recovered from an episode of non-specific LBP within the last 6 months. Those allocated to the intervention group will receive six sessions (three face to face and three telephone delivered) with a trained physiotherapist to facilitate a progressive walking programme and education over a 6-month period. The primary outcome will be days to first recurrence of an episode of activity-limiting LBP. The secondary outcomes include days to recurrence of an episode of LBP, days to recurrence of an episode of LBP leading to care seeking, disability and quality of life measured at 3, 6, 9 and 12 months and costs associated with LBP recurrence. All participants will be followed up monthly for a minimum of 12 months. The primary intention-to-treat analysis will assess difference in survival curves (days to recurrence) using the log-rank statistic. The cost-effectiveness analysis will be conducted from the societal perspective.Ethics and disseminationApproved by Macquarie University Human Research Ethics Committee (Reference: 5201949218164, May 2019). Findings will be disseminated through publication in peer-reviewed journals and conference presentations.Trial registration numberACTRN12619001134112.

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The effectiveness of a stratified care model for non-specific low back pain in Danish primary care compared to current practice: study protocol of a randomised controlled trial

Trials ◽

10.1186/s13063-018-2685-5 ◽

2018 ◽

Vol 19 (1) ◽

Cited By ~ 3

Author(s):

Lars Morso ◽

Berit Schiøttz-Christensen ◽

Jens Søndergaard ◽

Nils-Bo de Vos Andersen ◽

Flemming Pedersen ◽

...

Keyword(s):

Primary Care ◽

Low Back Pain ◽

Back Pain ◽

Randomised Controlled Trial ◽

Current Practice ◽

Controlled Trial ◽

Low Back ◽

Care Model ◽

Stratified Care ◽

Randomised Controlled

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Individualised cognitive functional therapy compared with a combined exercise and pain education class for patients with non-specific chronic low back pain: study protocol for a multicentre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2014-007156 ◽

2015 ◽

Vol 5 (6) ◽

pp. e007156-e007156 ◽

Cited By ~ 16

Author(s):

M. O'Keeffe ◽

H. Purtill ◽

N. Kennedy ◽

P. O'Sullivan ◽

W. Dankaerts ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Randomised Controlled Trial ◽

Chronic Low Back Pain ◽

Controlled Trial ◽

Low Back ◽

Functional Therapy ◽

Pain Education ◽

Education Class ◽

Randomised Controlled

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Pain education to prevent chronic low back pain: a study protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2014-005505 ◽

2014 ◽

Vol 4 (6) ◽

pp. e005505-e005505 ◽

Cited By ~ 30

Author(s):

A. C. Traeger ◽

G. L. Moseley ◽

M. Hubscher ◽

H. Lee ◽

I. W. Skinner ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Randomised Controlled Trial ◽

Study Protocol ◽

Chronic Low Back Pain ◽

Controlled Trial ◽

Low Back ◽

Pain Education ◽

Randomised Controlled

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Individualised cognitive functional therapy compared with a combined exercise and pain education class for patients with non-specific chronic low back pain: A multicentre randomised controlled trial

Manual Therapy ◽

10.1016/j.math.2016.05.130 ◽

2016 ◽

Vol 25 ◽

pp. e79-e80 ◽

Cited By ~ 1

Author(s):

M. O'Keeffe ◽

H. Purtill ◽

N. Kennedy ◽

P. O'Sullivan ◽

W. Dankaerts ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Randomised Controlled Trial ◽

Chronic Low Back Pain ◽

Controlled Trial ◽

Low Back ◽

Functional Therapy ◽

Pain Education ◽

Education Class ◽

Randomised Controlled

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A MULTICENTRE DOUBLE-BLIND RANDOMISED CONTROLLED TRIAL TO ASSESS THE CLINICAL- AND COST-EFFECTIVENESS OF FACET-JOINT INJECTIONS IN PATIENTS WITH NON-SPECIFIC LOW BACK PAIN: A FEASIBILITY STUDY

10.26226/morressier.59ad4811d462b80290b53a8a ◽

2017 ◽

Author(s):

Ahmad Alia

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Facet Joint ◽

Controlled Trial ◽

Low Back ◽

Double Blind ◽

Randomised Controlled ◽

Joint Injections

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Faculty Opinions recommendation of Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.13491975.15768194 ◽

2012 ◽

Author(s):

Riekie de Vet

Keyword(s):

Primary Care ◽

Low Back Pain ◽

Back Pain ◽

Randomised Controlled Trial ◽

Care Management ◽

Best Practice ◽

Controlled Trial ◽

Low Back ◽

Randomised Controlled ◽

Primary Care Management

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Protocol for a feasibility randomised controlled trial comparing cognitive functional therapy with usual physiotherapy care in people with persistent low back pain

Physiotherapy Practice and Research ◽

10.3233/ppr-200488 ◽

2021 ◽

pp. 1-14

Author(s):

Christopher Newton ◽

Gurpreet Singh ◽

David Nolan ◽

Vicky Booth ◽

Claire Diver ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Low Back ◽

Functional Therapy ◽

Randomised Controlled ◽

The Uk ◽

Feasibility Rct

BACKGROUND: Combined physical and psychological programmes (CPPP) are recommended for people with disabling low back pain (LBP). Cognitive Functional Therapy (CFT) is a physiotherapist-led low intensity CPPP with positive effects in previous studies. The clinical and cost effectiveness of CFT has not previously been evaluated in a randomised controlled trial (RCT) in the United Kingdom (UK) National Health Service (NHS). Before a definitive RCT can be completed it is necessary to determine if completing such a study is possible. PURPOSE: To determine the feasibility of completing a definitive RCT, that will evaluate the clinical and cost-effectiveness of CFT in comparison to usual physiotherapy care for people with persistent LBP in the UK NHS. METHODS: A pragmatic two-arm parallel feasibility RCT comparing CFT with usual physiotherapy care for people with persistent LBP will be completed. Sixty participants will be randomly allocated to receive CFT or usual physiotherapy care. The primary outcome will be feasibility of completing a definitive RCT. Participant reported outcome measures will be recorded at baseline, three, six and twelve-month follow-up, including disability, pain intensity, quality of life and psychosocial function. Data will be analysed descriptively. A qualitative process evaluation will explore the acceptability of the research processes and interventions. DISCUSSION: The rationale and methodological design of a mixed methods feasibility RCT is presented. This study aims to inform the planning, design and completion of a future definitive RCT in the UK NHS. The results will be disseminated through peer reviewed open access journal publication.

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