Comparison of a stratified group intervention (start back) with usual group care in patients with low back pain: A non-randomised controlled trial

2017 ◽  
Vol 28 ◽  
pp. e8
Author(s):  
S. Murphy ◽  
C. Blake ◽  
B. Fullen
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Group Intervention ◽  
Controlled Trial ◽  
Group Care ◽  
Low Back ◽  
Stratified Group ◽  
Randomised Controlled

scholarly journals Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT)

2019 ◽  
Vol 54 (13) ◽  
pp. 782-789 ◽  
Author(s):  
Mary O'Keeffe ◽  
Peter O'Sullivan ◽  
Helen Purtill ◽  
Norma Bargary ◽  
Kieran O'Sullivan
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Chronic Low Back Pain ◽  
Group Intervention ◽  
Controlled Trial ◽  
Mean Difference ◽  
Low Back ◽  
Functional Therapy ◽  
Randomised Controlled

BackgroundOne-size-fits-all interventions reduce chronic low back pain (CLBP) a small amount. An individualised intervention called cognitive functional therapy (CFT) was superior for CLBP compared with manual therapy and exercise in one randomised controlled trial (RCT). However, systematic reviews show group interventions are as effective as one-to-one interventions for musculoskeletal pain. This RCT investigated whether a physiotherapist-delivered individualised intervention (CFT) was more effective than physiotherapist-delivered group-based exercise and education for individuals with CLBP.Methods206 adults with CLBP were randomised to either CFT (n=106) or group-based exercise and education (n=100). The length of the CFT intervention varied according to the clinical progression of participants (mean=5 treatments). The group intervention consisted of up to 6 classes (mean=4 classes) over 6–8 weeks. Primary outcomes were disability and pain intensity in the past week at 6 months and 12months postrandomisation. Analysis was by intention-to-treat using linear mixed models.ResultsCFT reduced disability more than the group intervention at 6 months (mean difference, 8.65; 95% CI 3.66 to 13.64; p=0.001), and at 12 months (mean difference, 7.02; 95% CI 2.24 to 11.80; p=0.004). There were no between-group differences observed in pain intensity at 6 months (mean difference, 0.76; 95% CI -0.02 to 1.54; p=0.056) or 12 months (mean difference, 0.65; 95% CI -0.20 to 1.50; p=0.134).ConclusionCFT reduced disability, but not pain, at 6 and 12 months compared with the group-based exercise and education intervention. Future research should examine whether the greater reduction in disability achieved by CFT renders worthwhile differences for health systems and patients.Trial registration numberClinicalTrials.gov registry (NCT02145728).

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.

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