scholarly journals Which treatment for low back pain? A factorial randomised controlled trial comparing intravenous analgesics with oral analgesics in the emergency department and a centrally acting muscle relaxant with placebo over three days [ISRCTN09719705]

2001 ◽  
Vol 1 (1) ◽  
Author(s):  
Christof Havel ◽  
Anna Sieder ◽  
Harald Herkner ◽  
Hans Domanovits ◽  
Mascha Schmied ◽  
...  
Keyword(s):  
Emergency Department ◽  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Muscle Relaxant ◽  
Controlled Trial ◽  
Low Back ◽  
Randomised Controlled ◽  
Acting Muscle

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.

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