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

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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A multicentred randomised controlled trial of a primary care-based cognitive behavioural programme for low back pain: the Back Skills Training (BeST) trial

Clinical Governance An International Journal ◽

10.1108/cgij.2011.24816aaf.002 ◽

2011 ◽

Vol 16 (1) ◽

Keyword(s):

Primary Care ◽

Low Back Pain ◽

Back Pain ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Skills Training ◽

Low Back ◽

Cognitive Behavioural ◽

Randomised Controlled

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Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2)

BMJ Open ◽

10.1136/bmjopen-2020-040543 ◽

2020 ◽

Vol 10 (8) ◽

pp. e040543

Author(s):

Adam W A Geraghty ◽

Lisa Roberts ◽

Jonathan Hill ◽

Nadine E Foster ◽

Lucy Yardley ◽

...

Keyword(s):

Primary Care ◽

Low Back Pain ◽

Back Pain ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Internet Intervention ◽

Self Management ◽

Low Back ◽

Telephone Support ◽

Randomised Controlled

IntroductionSelf-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the ‘SupportBack’ internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients.Methods and analysisA three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted.Ethics and disseminationThis trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy.Trial registration numberISRCTN14736486.

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