Effectiveness of brief patient information materials for promoting correct beliefs about imaging and inevitable consequences of low back pain: A randomised controlled trial

2021 ◽  
pp. 026921552110659
Author(s):  
Leandro M. Diniz ◽  
Crystian B. Oliveira ◽  
Gustavo C. Machado ◽  
Christopher G. Maher ◽  
Arianne P. Verhagen ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Patient Information ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Low Back ◽  
Information Materials ◽  
Randomised Controlled ◽  
To Receive

Objective To investigate what format for providing patient information (i.e. written summary, infographic or video animation) is most effective for promoting correct beliefs about imaging and inevitable consequences of low back pain (LBP). Design Randomised controlled trial. Setting/Patients One hundred and fifty-nine patients with non-specific LBP were recruited from outpatient physiotherapy clinics. Intervention Participants were randomised to receive patient information in one of three formats: video animation, infographic or written summary. Patients were allowed to read or watch the materials for up to 20 min. Measurements Outcome were assessed before and immediately after the intervention. The primary outcome was the Back Beliefs Questionnaire. The secondary outcome was beliefs about imaging for LBP assessed by two questions. Results All 159 patients completed the study. Our findings revealed no difference between groups for the Back Beliefs Questionnaire. Correct beliefs about imaging were more likely with the infographic than the video animation (Question 1- Odds Ratio [OR] = 3.9, 95% confidence interval [CI]: 1.7, 8.7; Question 2- OR = 6.8, 95%CI: 2.7, 17.2) and more likely with the written summary than the video animation (Question 1- OR = 3.3, 95%CI: 1.5, 7.4; Question 2- OR = 3.7, 95%CI: 1.6, 8.5). No difference between infographic and written summary formats were reported for the questions assessing LBP imaging beliefs. Conclusion The three materials were equally effective in improving patient's general beliefs about LBP care. However, the traditional written summary or infographic formats were more effective than the video animation format for improving beliefs about imaging for LBP.

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

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.

scholarly journals Exercise intervention for unilateral amputees with low back pain: study protocol for a randomised, controlled trial

Trials ◽  
2017 ◽  
Vol 18 (1) ◽  
Author(s):  
Joseph G. Wasser ◽  
Daniel C. Herman ◽  
MaryBeth Horodyski ◽  
Jason L. Zaremski ◽  
Brady Tripp ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Low Back ◽  
Randomised Controlled

scholarly journals 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

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e056339
Author(s):  
Joshua R Zadro ◽  
Christopher Needs ◽  
Nadine E Foster ◽  
David Martens ◽  
Danielle M Coombs ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Waiting Times ◽  
Education Programme ◽  
Low Back ◽  
Pain Education ◽  
Stratified Care ◽  
Randomised Controlled

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.

scholarly journals Feasibility study on recruitment in general practice for a low back pain online information study (part of the ADVIN Back Trial)

2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Allan Riis ◽  
Michael Skovdal Rathleff ◽  
Jan Hartvigsen ◽  
Janus Laust Thomsen ◽  
Tamana Afzali ◽  
...  
Keyword(s):  
General Practice ◽  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Web Application ◽  
Controlled Trial ◽  
Low Back ◽  
Loss To Follow Up ◽  
Randomised Controlled

Abstract Objective In a future full-scale randomised controlled trial, we plan to compare satisfaction with a standard website versus satisfaction with a participatory driven web-application. The participatory driven web-application may facilitate the delivery of targeted evidence-based advice and information to patients with low back pain in general practice (ClinicalTrials.gov Identifier: NCT03088774). This feasibility study is intended to inform a future randomised controlled trial. The aim is to report on the lessons learned from recruitment to report on reasons for loss to follow-up. Results We recruited 12 women and 8 men from two general practices with each practice recruiting for 3 months. Full follow-up data was available in only three patients (15%). Based on the high loss to follow-up, we do not consider it feasible to conduct the full-scale confirmatory trial as planned. Modifying inclusion criteria to include only patients expressing an interest in using online health information or randomising patients directly at the general practice, supporting them in accessing the web-application, and letting patients respond with their immediate satisfaction may improve the speed of recruitment and follow-up rates. Furthermore, the participatory driven web-application can be included in a larger multi-faceted intervention, making the combined intervention seem more relevant to study participants.

scholarly journals 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 ◽  
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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