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Comparison of a Stratified Group Intervention (Start Back) with Usual Group Care in Patients with Low Back Pain: a Nonrandomized Controlled Trial

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Comparison of a Stratified Group Intervention (Start Back) with Usual Group Care in Patients with Low Back Pain: a Nonrandomized Controlled Trial SPINE Volume 41, Number 8, pp 645–652 ß 2016 Wolters Kluwer Health, Inc. All rights reserved RANDOMIZED TRIAL Comparison of a Stratified Group Intervention (STarT Back) With Usual Group Care in Patients With Low Back Pain: A Nonrandomized Controlled Trial Susan E. Murphy, PhD,Ã Catherine Blake, PhD,y Camillus K. Power, MD,z and Brona M. Fullen, PhDy outcome over the controls (P ¼ 0.031). The medium-risk strati- Study Design. A nonrandomized controlled trial. fied intervention demonstrated equally good outcomes Objective. This study aims to explore the effectiveness of (P ¼ 0.125), and low-risk stratified patients, despite less interven- group-based stratified care in primary care. Summary of Background Data. Stratified care based on tion, did as well as the historical controls (P ¼ 0.993). Conclusion. Stratified care delivered in a group setting demon- psychosocial screening (STarT Back) has demonstrated greater strated superior outcomes in the high-risk patients, and equally clinical and cost-effectiveness in patients with low back pain. good outcomes for the medium and low-risk groups. This model, However, low back pain interventions are often delivered in embedded in primary care, provides an early and effective groups and evaluating this system of care in a group setting is model of chronic disease management and adds another dimen- important. Methods. Patients were recruited from 60 general practices and sion to the utility of the STarT Back system of care. Key words: low back pain, physiotherapy-led group linked physiotherapy services. A new group stratified intervention intervention, primary care, STarT back tool, stratification. was compared with a historical nonstratified control group. Level of Evidence: 2 Patients stratified as low, medium and high risk were offered risk- Spine 2016;41:645–652 matched group care. Consenting participants completed self-report measures of functional disability (primary outcome measure), pain, psychological distress, and beliefs. The historical control received a generic group intervention. Analysis was by intention to treat. ow back pain (LBP) is a leading cause of disability Results. In total, 251 patients in the new stratified intervention worldwide with an estimated 632 million people 1 and 332 in the historical control were included in the primary affected. It is one of the principle reasons for visiting L 2 analysis at 12 weeks. The mean age of patients was 43 Æ 10.98 general practitioners and constitutes a major drain on 3 years. Overall adjusted mean changes in the RMDQ scores were health system resources. Current best practice advocates higher in the stratified intervention than in the control arm at that LBP patients are managed conservatively within a 4 12-week follow-up (P ¼ 0.028). Exploring the risk groups, indivi- biospychosocial framework. However, despite the prolifer- dually the high-risk stratified group, demonstrated better ation of clinical trials, available treatments tend to produce at best, small to moderate effects.5–7 Emerging evidence demonstrates that stratifying patients into more hom- From the ÃBackCare Programme, Orthopaedic Department, University y ogenous groups and offering targeted treatment leads to Hospital, Waterford, Ireland; School of Public Health, Physiotherapy 8–10 and Population Science, University College, Dublin, Ireland; and zPain better patient outcomes. Service, Adelaide and Meath Hospital, Dublin, Ireland. The STarT Back Trial has demonstrated efficacy with Acknowledgment date: May 26, 2015. First revision date: October 8, 2015. respect to prognostic risk stratification on an individual Acceptance date: October 9, 2015. basis within the controlled environment of a randomized The manuscript submitted does not contain information about medical 8 device(s)/drug(s). controlled trial (RCT). The translation of this model of An unrestricted educational grant from Pfizer Healthcare, Ireland, was care to everyday clinical practice is the next phase in the received in support of this work. implementation of this system of care. LBP interventions No relevant financial activities outside the submitted work. can be delivered individually or in groups. The use of Address correspondence and reprint requests to Susan E. Murphy, PhD, group-based programs is well established and is equally Back Care Programme, Orthopaedic Department, University Hospital, efficacious as individual physical therapy and has the added Waterford, Ireland; E-mail: [email protected] advantage of promoting self-management and greater 4,11,12 DOI: 10.1097/BRS.0000000000001305 cost-effectiveness. Spine www.spinejournal.com 645 Copyright © 2016 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. RANDOMIZED TRIAL Stratified Group Intervention (STarT Back) Murphy et al The STarT Back system, in particular, allows early identi- and though stratified using the STarT Back Tool, received a fication of the more psychologically distressed patients (high 12-week generic group (‘‘one treatment fits all’’) interven- risk). Approximately one-third of primary care patients tion. Physiotherapists delivering the intervention were have a psychosocial dominance8,13 and these are the patients unaware of which risk group the patient belonged to. who pose the greatest burden to health services.8 Identifying Patients attended four 90-minute group exercise/education early effective systems of care for these patients is import- sessions, with 8 to 10 participants over 4 weeks. Sessions ant.14 Low-intensity structured psychological interventions were conducted within a biopsychosocial framework and are not routinely offered in primary care and only advocated included positive evidence-based messages on managing if initial interventions fail.4 To date, the effectiveness of LBP, general ergonomic advice, a stability exercise program, group-stratified care has not been explored in the primary and physical activity promotion.16 Physical activity levels care setting. and adherence to the exercise program were monitored over the duration of the program. MATERIALS AND METHODS In the stratified arm, low-risk patients attended a single The methods are reported in full in the protocol.15 This study 1.5 hour small group education/exercise session promoting compared a new stratified group intervention with a histori- active management of their LBP and outlining positive messages on maintaining a healthy spine, in line with the cal nonstratified control treatment, within a single clinical 16 center, thus removing the risk of differences in management ‘‘The Back Book.’’ Patients were instructed with simple between centers. A pragmatic study, embedded in the clinical back exercises and encouraged to be active in their lifestyle. setting, it particularly aimed to explore outcomes in the more The medium-risk intervention was modeled on the historical group intervention (see above) as that intervention psychologically distressed high-risk group. Patient assess- 12 ment occurred at baseline and at 12 weeks. had demonstrated efficacy. As per the historical control, Our study tested the hypotheses that patients attended four 90-minute group exercise/education sessions over 4 weeks with the same content and structure as (1) Patients stratified to the new ‘‘high-risk’’ group inter- the historical intervention. vention (STarT Back) will have better physical and High-risk patients attended four 120-minute group ses- psychological outcomes than a ‘‘high-risk’’ historical sions. Each group consisted of approximately 4 to 6 patients control group. and an informal problem-solving approach was utilized. (2) Patients stratified to the ‘‘medium’’ and ‘‘low-risk’’ The content was modeled on the ‘‘high-risk’’ intervention 8 group interventions (STarT Back) will have better delivered in the STarT Back Trial. Sessions utilized cogni- physical and psychological outcomes than the tive behavioral (CBT) strategies to promote self-manage- ‘‘medium’’ and ‘‘low’’ risk historical control groups. ment and address unhelpful beliefs and behaviors around LBP. Each session also included an exercise component Ethical approval was granted from University Hospital similar to the medium-risk intervention. Physical therapists Waterford ethics committee (June 2011). delivering the high-risk intervention received additional training to enhance their CBT skills.17 Participants Patients referred by their GP to a primary care physiother- Outcomes Measures apy led spinal triage clinic in the south east of Ireland were Demographic data and clinical outcomes were gathered at invited to participate (February 2012–June 2013). Patients baseline and 12 weeks. The Roland Morris Disability Ques- were included if they were over 18 years old, English speak- tionnaire (RMDQ: scale 0–24; high scores indicate severe ing, had LBP of greater than 3 months duration, with or disability)18 was the primary outcome measure in keeping without associated leg symptoms. Patients with potentially with prior research.8 serious spinal pathology, serious illness, previous spinal Secondary measures included LBP intensity [visual ana- surgery, or who were pregnant were excluded. Physiothera- log scale (VAS)],19 back beliefs [back beliefs questionnaire pists were at senior or clinical specialist level. (BBQ)],20 distress [distress and risk assessment method (DRAM)],21 and a 6-point self-rated scale (worse, Procedure unchanged, <25% better, 25–50% better, 51–75% better, At initial screening, patients were routinely assessed, out- and >75% better).
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