Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2018-022205 on 18 October 2018. Downloaded from Better Outcomes for Older people with Spinal Trouble (BOOST) Trial: a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication, a protocol Esther Williamson,1 Lesley Ward,1 Karan Vadher,2 Susan J Dutton,2 Ben Parker,3 Stavros Petrou,3 Charles E Hutchinson,3 Richard Gagen,3 Nigel K Arden,4 Karen Barker,4,5 Graham Boniface,1 Julie Bruce,3 Gary Collins,2 Jeremy Fairbank,4 Judith Fitch,6 David P French,7 Angela Garrett,1 Varsha Gandhi,1 Frances Griffiths,3 Zara Hansen,1 Christian Mallen,8 Alana Morris,1 Sarah E Lamb1,2 To cite: Williamson E, ABSTRACT Strengths and limitations of this study Ward L, Vadher K, et al. Introduction Neurogenic claudication due to spinal Better Outcomes for Older stenosis is common in older adults. The effectiveness of ► The BOOST (Better Outcomes for Older people people with Spinal Trouble conservative interventions is not known. The aim of the (BOOST) Trial: a randomised with Spinal Trouble) Trial is a large, multicentred, study is to estimate the clinical and cost-effectiveness controlled trial of a combined randomised controlled trial with a prespecified sam- of a physiotherapist-delivered, combined physical and physical and psychological ple size estimate and includes health economic and psychological intervention. intervention for older adults qualitative evaluations. with neurogenic claudication, Methods and analysis This is a pragmatic, multicentred, ► The primary outcome is the Oswestry Disability randomised controlled trial. Participants are randomised a protocol. BMJ Open Index, but we also collect a range of secondary 2018;8:e022205. doi:10.1136/ to a combined physical and psychological intervention outcomes including objective physical capacity http://bmjopen.bmj.com/ bmjopen-2018-022205 (Better Outcomes for Older people with Spinal Trouble measures and self-reported pain, symptoms and (BOOST) programme) or best practice advice (control). ► Prepublication history for mobility, which are highly relevant to this patient Community-dwelling adults, 65 years and over, with this paper is available online. group. To view these files, please visit neurogenic claudication are identified from community and ► The intervention is individually tailored and uses secondary care services. Recruitment is supplemented the journal online (http:// dx. doi. group supervision to maximise the potential for org/ 10. 1136/ bmjopen- 2018- using a primary care-based cohort. Participants are cost-effectiveness. 022205). registered prospectively and randomised in a 2:1 ratio ► Due to the nature of the intervention, participants (intervention:control) using a web-based service to cannot be blinded to treatment allocation. Received 6 February 2018 ensure allocation concealment. The target sample size Revised 21 August 2018 ► At some sites, the same physiotherapist is delivering on September 26, 2021 by guest. Protected copyright. is a minimum of 402. The BOOST programme consists Accepted 30 August 2018 both trial interventions, but treatments are delivered of an individual assessment and twelve 90 min classes, according to a manualised protocol and quality con- including education and discussion underpinned by trol visits are conducted to reduce the risk of intro- cognitive behavioural techniques, exercises and walking ducing bias to the trial. circuit. During and after the classes, participants undertake home exercises and there are two support telephone calls to promote adherence with the exercises. Best practice advice is delivered in one to three individual sessions with 16/LO/0349). This protocol adheres to the Standard Protocol a physiotherapist. The primary outcome is the Oswestry Items: Recommendations for Interventional Trials checklist. © Author(s) (or their Disability Index at 12 months. Secondary outcomes The results will be reported at conferences and in peer- employer(s)) 2018. Re-use include the 6 Minute Walk Test, Short Physical Performance reviewed publications using the Consolidated Standards of permitted under CC BY. Battery, Fear Avoidance Beliefs Questionnaire and Gait Reporting Trials guidelines. A plain English summary will be Published by BMJ. Self-Efficacy Scale. Outcomes are measured at 6 and published on the BOOST website. For numbered affiliations see 12 months by researchers who are masked to treatment Trial registration number ISRCTN12698674; Pre-results. end of article. allocation. The primary statistical analysis will be by Correspondence to ‘intention to treat’. There is a parallel health economic Dr Esther Williamson; evaluation and qualitative study. INTRODUCTIon esther. williamson@ ndorms. ox. Ethics and dissemination Ethical approval was given on 3 Neurogenic claudication (NC) is a condi- ac. uk March 2016 (National Research Ethics Committee number: tion that frequently affects older adults.1 The Williamson E, et al. BMJ Open 2018;8:e022205. doi:10.1136/bmjopen-2018-022205 1 Open access BMJ Open: first published as 10.1136/bmjopen-2018-022205 on 18 October 2018. Downloaded from burden of symptoms is substantial. NC presents as pain, METHODS/DESIGN discomfort or other symptoms radiating from the spine Overview into the buttocks and legs, which are provoked by walking The study design is a multicentred RCT with embedded or prolonged standing and relieved by sitting or lumbar qualitative study and economic evaluation (see figure 1). flexion.2 Other signs and symptoms include weakness, We are currently recruiting community-dwelling altered sensation, fatigue and gait changes.2 Pain in the older adults with symptoms of NC. Recruitment opened lower back is usual but not a necessary diagnostic feature. on 25 July 2016 and we anticipate recruitment to be The symptoms of NC are thought to arise from pressure completed around June 2018. Participants are identified on the nerves and blood vessels in the spinal canal caused from National Health Service (NHS) physiotherapy and by degenerative changes narrowing the volume of the consultant spinal clinics in community and secondary spinal canal. Narrowing may or may not be evident on care settings. In addition, participants are identified radiological imaging.2 3 When narrowing is evident radio- through a primary care-based cohort study (the Oxford logically, the condition is termed lumbar spinal stenosis Pain, Activity and Lifestyle (OPAL) cohort study). The (LSS). The relationship between imaging results and OPAL cohort study is being conducted in the same local- symptoms is inconsistent as not all people with radiolog- ities as the trial. ical narrowing report symptoms of NC.2 3 The experimental intervention is a physiotherapist-de- Symptoms due to spinal stenosis are the most common livered, combined physical and psychological programme. reason for spinal surgery in people over 65 years of age.4 Participants attend an individual session, followed by 12 However, the effectiveness of surgery is unclear, and it group sessions delivered over a 12-week period. During exposes older people to considerable risk of complica- the individual session, participants undergo an assessment tions, including wound infection and cardiorespiratory and are prescribed the exercises they will carry out during problems.4–6 Surgery is also expensive. Current clin- the group sessions tailored to their ability, symptom ical guidelines suggest that physiotherapy is an option presentation and general health. The group sessions for patients with symptoms arising from LSS before consist of (1) education and group discussion based on proceeding to surgery.7 However, we do not know cognitive behavioural (CB) techniques; (2) warm-up and whether physiotherapy is effective, nor which physio- circuit exercises; and (3) a walking circuit. The educa- therapy techniques should be used.8 A Cochrane system- tion component focuses on pain management strategies, atic literature review reports that the current evidence engagement with home exercises and increasing physical for non-operative care for people with NC is very low to activity. The exercises target muscle strength, balance low quality.9 All recent reviews agree that higher quality and flexibility, while the walking circuit aims to increase trials are needed.9–13 Despite NC being a condition associ- walking self-efficacy and mobility. The education compo- ated with older age, interventions tested to date have not nent and supervised exercise are provided in groups of targeted age-associated changes in the musculoskeletal approximately six participants to maximise the potential http://bmjopen.bmj.com/ system of participants (such as generalised sarcopenia for cost-effectiveness. There are two follow-up phone calls and frailty) or the psychological impact of pain. In order on completion of the group sessions to encourage adher- to generate high-quality evidence regarding non-surgical ence with the home exercise programme. care for NC, our aim is to conduct a high-quality, multi- The comparator is advice given by a physiotherapist centred, randomised controlled trial (RCT) of a physio- (best practice advice), ideally in one session, but up to two therapist-delivered, combined physical and psychological further review sessions are permissible. Advice includes intervention. self-management strategies, home exercises and encour- agement to increase physical activity. on September 26, 2021 by guest. Protected copyright. Participants are randomised