EFFICACY AND MECHANISM EVALUATION VOLUME 1 ISSUE 2 OCTOBER 2014 ISSN 2050-4365 Alexander technique and Supervised Physiotherapy Exercises in back paiN (ASPEN): a four-group randomised feasibility trial Paul Little, Beth Stuart, Maria Stokes, Carolyn Nicholls, Lisa Roberts, Stephen Preece, Tim Cacciatore, Simon Brown, George Lewith, Adam Geraghty, Lucy Yardley, Gilly O’Reilly, Caroline Chalk, Debbie Sharp and Peter Smith DOI 10.3310/eme01020 Alexander technique and Supervised Physiotherapy Exercises in back paiN (ASPEN): a four-group randomised feasibility trial Paul Little,1* Beth Stuart,1 Maria Stokes,2 Carolyn Nicholls,3 Lisa Roberts,2 Stephen Preece,4 Tim Cacciatore,5 Simon Brown,2 George Lewith,1 ’ Adam Geraghty,1 Lucy Yardley,6 Gilly O Reilly,1 Caroline Chalk,7 Debbie Sharp8 and Peter Smith9 1Primary Care and Population Sciences Group, University of Southampton, Southampton, UK 2Faculty of Health Sciences, University of Southampton, Southampton, UK 3Brighton Alexander Technique College, Brighton, UK 4School of Health Sciences, University of Salford, Salford, UK 5Institute of Neurology, University College London, London, UK 6School of Psychology, University of Southampton, Southampton, UK 7Bristol Alexander School, Bristol, UK 8Centre for Academic Primary Care, University of Bristol, Bristol, UK 9Southampton Statistical Sciences Research Institute, University of Southampton, Southampton, UK *Corresponding author Declared competing interests of authors: PaulLittle iseditor-in-chief of theProgramme Grants for Applied Research journal. Published October 2014 DOI: 10.3310/eme01020 This reportshould be referenced as follows: Little P, Stuart B, StokesM, Nicholls C, Roberts L, Preece S,et al. Alexander technique and Supervised Physiotherapy Exercises in back paiN (ASPEN): afour-group randomised feasibility trial. Efficacy Mech Eval 2014;1(2). Efficacy and Mechanism Evaluation ISSN2050-4365(Print) ISSN2050-4373(Online) ThisjournalisamemberofandsubscribestotheprinciplesoftheCommitteeonPublicationEthics(COPE)(www.publicationethics.org/). Editorialcontact:[email protected] ThefullEMEarchiveisfreelyavailabletoviewonlineatwww.journalslibrary.nihr.ac.uk/eme.Print-on-demandcopiescanbepurchasedfrom thereportpagesoftheNIHRJournalsLibrarywebsite:www.journalslibrary.nihr.ac.uk CriteriaforinclusionintheEfficacyandMechanismEvaluationjournal ReportsarepublishedinEfficacyandMechanismEvaluation(EME)if(1)theyhaveresultedfromworkfortheEMEprogramme,and (2)theyareofasufficientlyhighscientificqualityasassessedbythereviewersandeditors. 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Efficacy and Mechanism Evaluation Editor-in-Chief Professor Raj Thakker May Professor of Medicine, Nuffield Department of Medicine, University of Oxford, UK NIHR Journals Library Editor-in-Chief Professor Tom Walley Director, NIHR Evaluation, Trials and Studies and Director of the HTA Programme, UK NIHR Journals Library Editors Professor Ken Stein Chair of HTA Editorial Board and Professor of Public Health, University of Exeter Medical School, UK Professor Andree Le May Chair of NIHR Journals Library Editorial Group (EME, HS&DR, PGfAR, PHR journals) Dr Martin Ashton-Key Consultant in Public Health Medicine/Consultant Advisor, NETSCC, UK Professor Matthias Beck Chair in Public Sector Management and Subject Leader (Management Group), Queen’s University Management School, Queen’s University Belfast, UK Professor Aileen Clarke Professor of Public Health and Health Services Research, Warwick Medical School, University of Warwick, UK Dr Tessa Crilly Director, Crystal Blue Consulting Ltd, UK Dr Peter Davidson Director of NETSCC, HTA, UK Ms Tara Lamont Scientific Advisor, NETSCC, UK Professor Elaine McColl Director, Newcastle Clinical Trials Unit, Institute of Health and Society, Newcastle University, UK Professor William McGuire Professor of Child Health, Hull York Medical School, University of York, UK Professor Geoffrey Meads Professor of Health Sciences Research, Faculty of Education, University of Winchester, UK Professor Jane Norman Professor of Maternal and Fetal Health, University of Edinburgh, UK Professor John Powell Consultant Clinical Adviser, National Institute for Health and Care Excellence (NICE), UK Professor James Raftery Professor of Health Technology Assessment, Wessex Institute, Faculty of Medicine, University of Southampton, UK Dr Rob Riemsma Reviews Manager, Kleijnen Systematic Reviews Ltd, UK Professor Helen Roberts Professor of Child Health Research, University College London, UK Professor Helen Snooks Professor of Health Services Research, Institute of Life Science, College of Medicine, Swansea University, UK Please visit the website for a list of members of the NIHR Journals Library Board: www.journalslibrary.nihr.ac.uk/about/editors Editorial contact: [email protected] NIHRJournalsLibrary www.journalslibrary.nihr.ac.uk DOI:10.3310/eme01020 EFFICACYANDMECHANISMEVALUATION2014 VOL.1 NO.2 Abstract Alexander technique and Supervised Physiotherapy Exercises in back paiN (ASPEN): a four-group randomised feasibility trial Paul Little,1* Beth Stuart,1 Maria Stokes,2 Carolyn Nicholls,3 Lisa Roberts,2 Stephen Preece,4 Tim Cacciatore,5 Simon Brown,2 George Lewith,1 Adam Geraghty,1 Lucy Yardley,6 Gilly O’Reilly,1 Caroline Chalk,7 Debbie Sharp8 and Peter Smith9 1Primary Careand Population Sciences Group, University ofSouthampton, Southampton, UK 2Faculty of Health Sciences, University of Southampton, Southampton, UK 3Brighton Alexander Technique College, Brighton, UK 4School ofHealth Sciences, University of Salford, Salford, UK 5Institute of Neurology, University College London, London, UK 6School ofPsychology, University ofSouthampton, Southampton, UK 7Bristol Alexander School, Bristol, UK 8Centre forAcademic Primary Care, University of Bristol, Bristol, UK 9Southampton Statistical Sciences Research Institute, University ofSouthampton, Southampton, UK *Corresponding author [email protected] Background: The Alexander technique probably helps back painbut itis unclearwhether or notit canbe combined with physiotherapy exercise classes, howmany lessons areneededand what mechanisms might be involved. Objectives: To undertake afeasibility trial of the Alexander technique and supervised exercise classes and perform exploratory biomechanical andneuromuscular physiological marker analysesto better understand mediators of recovery. Design: Feasibility parallel-group randomised controlled trial. Setting: General practices in southern England. Participants: Patients with recurrent back pain (atleast 3weeks’ duration of acurrent episode). Interventions: Participants were allocated by anexternal randomisation line to four groups: (1) normal care, (2) 10 Alexander technique lessons, (3) 12 physiotherapy exercise classes, (4) Alexander technique lessons plus exercise classes. Main outcome measures:The feasibility outcomes were recruitment, acceptability and follow-up. The clinical outcomes were theRoland–Morris Disability Questionnaire (RMDQ), days in pain, theVon Korff pain anddisability scale, overall improvement, fear of activity, enablement, the Oswestry Disability Index and theAberdeen painand function scale. Laboratory-based markers were axial muscle toneand flexibility, electrical activity, muscle toneand mechanical properties of elasticity andstiffness, trunk strength, and proprioception. ©Queen’sPrinterandControllerofHMSO2014.ThisworkwasproducedbyLittleetal.underthetermsofacommissioningcontractissuedbytheSecretaryofStateforHealth. Thisissuemaybefreelyreproducedforthepurposesofprivateresearchandstudyandextracts(orindeed,thefullreport)maybeincludedinprofessionaljournalsprovidedthat v suitableacknowledgementismadeandthereproductionisnotassociatedwithanyformofadvertising.Applicationsforcommercialreproductionshouldbeaddressedto:NIHR JournalsLibrary,NationalInstituteforHealthResearch,Evaluation,TrialsandStudiesCoordinatingCentre,AlphaHouse,UniversityofSouthamptonSciencePark,Southampton SO167NS,UK. ABSTRACT Results: Intotal, 83 patients consented, 69 were randomised and56 (81%) were followed up at 6 months.Most patients had long-standing pain (median >300 days of pain). TheRMDQ and other instruments were sensitive to changeand thepreliminary evidence suggests that the Aberdeen scale could be auseful measure. Study procedures were feasible and three methods of recruitment were successfully piloted. At 6months the control grouphad changed little (RMDQ1point lower than at baseline) and, compared with thecontrol group, clinically important improvements in RMDQ were seen in all groups, albeit not significant [Alexander technique −3.0, 95% confidence interval (CI) −6.7 to 0.8]; exercise classes −2.9, 95% CI −6.5to 0.8; combined Alexander technique+exercise classes −2.50, 9%CI −6.20 to 1.19]. Novel biomechanical variables strongly associated with RMDQ scoreat 6months were muscle tone (0.94 increase in RMDQ per unit increase in Hz, 95% CI 0.48 to 1.40; p<0.0001), lumbar proprioception (1.48 increase in RMDQ per degree, 95% CI 0.83 to 2.12;p<0.0001) and muscle elasticity (−4.86 increase in RMDQ perunit log decrement, 95% CI −0.01 to −9.72;p<0.05). At 3months the Alexander technique improved proprioception and exercise classes improved trunk extension strength. At 6months the Alexander technique improved thetiming of multifidus muscle onset and theactive straight leg raise test and exercise classes improved multifidus muscle thickness and theability to contract. The combined effects of theAlexander technique and exercise classes were improvements in muscle tone,elasticity and thickness and contractile ability. These observations provide possible links between intervention, proprioception, muscle tone and elasticity and outcome. Interms of harms, one patient fell in the exercise classgroup. Conclusions: The trial is feasible and theinterventions may provide clinically important benefits. Exploratory analysis suggests that muscle tone, elasticity and proprioception are strongly associated with improved RMDQ score and arelikely to be modified by theinterventions. Trial registration: Current Controlled Trials ISRCTN51496752. Funding: This project was funded bythe Medical Research Council throughthe Efficacy and Mechanism Evaluation Board. vi NIHRJournalsLibrary www.journalslibrary.nihr.ac.uk DOI:10.3310/eme01020 EFFICACYANDMECHANISMEVALUATION2014 VOL.1 NO.2 Contents List oftables ix List offigures xi List ofabbreviations xiii PlainEnglish summary xv Scientific summary xvii Chapter 1Introduction 1 Existing research 1 Physiotherapy exercises 1 Alexander technique 1 Mechanism and biomechanical/physiological markers of improvement 2 Alexander technique 2 Physiotherapy exercises 2 Risks andbenefits 3 Rationalefor the full trial 3 Chapter 2Research objectives 5 Chapter 3Methods 7 Research design 7 Changes or additions to the protocol since application 7 Study population 7 Planned interventions and proposed trial groups 8 Normal care 9 Outcome measures (at 3and 6months) 9 Assessment andfollow-up 11 Proposed sample size 11 Statistical analysis 12 Ethical arrangements 13 Research governance 13 Patient andpublic involvement 13 Chapter 4Results 15 Feasibility of recruitment 15 Invited recruitment for patient attending within thelast 5years 15 Opportunistic recruitment in surgery 15 Invited recruitment based on attendance in theprevious week 15 Feasibility of randomisation 16 Feasibility of intervention lessons 18 Logistical issues 18 Feasibility of delivering the intervention: compliance with attending intervention classes 18 ©Queen’sPrinterandControllerofHMSO2014.ThisworkwasproducedbyLittleetal.underthetermsofacommissioningcontractissuedbytheSecretaryofStateforHealth. Thisissuemaybefreelyreproducedforthepurposesofprivateresearchandstudyandextracts(orindeed,thefullreport)maybeincludedinprofessionaljournalsprovidedthat vii suitableacknowledgementismadeandthereproductionisnotassociatedwithanyformofadvertising.Applicationsforcommercialreproductionshouldbeaddressedto:NIHR JournalsLibrary,NationalInstituteforHealthResearch,Evaluation,TrialsandStudiesCoordinatingCentre,AlphaHouse,UniversityofSouthamptonSciencePark,Southampton SO167NS,UK. CONTENTS Feasibility of retention 19 Feasibility of laboratory-based biomechanical andneuromuscular physiological measures 19 Sensitivity to change 20 Clinical outcome measures 20 Change in laboratory-based measures 20 Exploratory analysesof effectiveness 20 Main clinical results 20 ‘Dose response’: rating of painand function by participants at Alexander technique lessons and exercise classes 26 Exploratory analysesof intermediate markers (laboratory-based tests) 28 Understanding key issues in thetrial: qualitative substudy 30 Feedbackfrom Alexander technique teachers 32 Chapter 5Discussion 33 Strengths and limitations 33 Feasibility outcomes 33 Feasibility of laboratory biomechanical tests 34 Clinical outcomes 34 Effects of the interventions onlaboratory measures at 3 months’ follow-up 35 Effects of the interventions onlaboratory measures at 6 months’ follow-up 35 Mechanisms of treatment effects during recovery 35 Sensitivity and predictive valueof assessment tools for later studies 36 Chapter 6Conclusion 39 Recommendations for afuturetrial 39 Acknowledgements 41 References 43 Appendix 1Alexander technique lessons and physiotherapy exercise classes 47 Appendix 2Laboratory measures 63 Appendix 3Qualitative study 73 Appendix 4Comments fromteachers fed backto Carolyn Nicholls 79 viii NIHRJournalsLibrary www.journalslibrary.nihr.ac.uk