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Using an internet intervention to support self-management of low back pain in primary care: findings from a randomised controlled feasibility trial (SupportBack).

ABSTRACT: OBJECTIVE:To determine the feasibility of a randomised controlled trial of an internet intervention for low back pain (LBP) using three arms: (1) usual care, (2) usual care plus an internet intervention or (3) usual care plus an internet intervention with additional physiotherapist telephone support. DESIGN AND SETTING:A three-armed randomised controlled feasibility trial conducted in 12 general practices in England. PARTICIPANTS:Primary care patients aged over 18 years, with current LBP, access to the internet and without indicators of serious spinal pathology or systemic illness. INTERVENTIONS:The 'SupportBack' internet intervention delivers a 6-week, tailored programme, focused on graded goal setting, self-monitoring and provision of tailored feedback to encourage physical activity. Additional physiotherapist telephone support consisted of three brief telephone calls over a 4-week period, to address any concerns and provide reassurance. OUTCOMES:The primary outcomes were the feasibility of the trial design including recruitment, adherence and retention at follow-up. Secondary descriptive and exploratory analyses were conducted on clinical outcomes including LBP-related disability at 3 months follow-up. RESULTS:Primary outcomes: 87 patients with LBP were recruited (target 60-90) over 6 months, and there were 3 withdrawals. Adherence to the intervention was higher in the physiotherapist-supported arm, compared with the stand-alone internet intervention. Trial physiotherapists adhered to the support protocol. Overall follow-up rate on key clinical outcomes at 3?months follow-up was 84%. CONCLUSIONS:This study demonstrated the feasibility of a future definitive randomised controlled trial to determine the clinical and cost-effectiveness of the SupportBack intervention in primary care patients with LBP. TRIAL REGISTRATION NUMBER:ISRCTN31034004; Results.

SUBMITTER: Geraghty AWA

PROVIDER: S-EPMC5879455 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Using an internet intervention to support self-management of low back pain in primary care: findings from a randomised controlled feasibility trial (SupportBack).

Geraghty Adam W A AWA Stanford Rosie R Stuart Beth B Little Paul P Roberts Lisa C LC Foster Nadine E NE Hill Jonathan C JC Hay Elaine M EM Turner David D Malakan Wansida W Leigh Linda L Yardley Lucy L

BMJ open 20180309 3

<h4>Objective</h4>To determine the feasibility of a randomised controlled trial of an internet intervention for low back pain (LBP) using three arms: (1) usual care, (2) usual care plus an internet intervention or (3) usual care plus an internet intervention with additional physiotherapist telephone support.<h4>Design and setting</h4>A three-armed randomised controlled feasibility trial conducted in 12 general practices in England.<h4>Participants</h4>Primary care patients aged over 18 years, wi ...[more]

PMID: 29525768

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Project description:To evaluate the feasibility of a phase 3 randomised controlled trial (RCT) of a website (Living Well with Asthma) to support self-management.Phase 2, parallel group, RCT, participants recruited from 20 general practices across Glasgow, UK. Randomisation through automated voice response, after baseline data collection, to website access for minimum 12 weeks or usual care.Adults (age≥16 years) with physician diagnosed, symptomatic asthma (Asthma Control Questionnaire (ACQ) score ≥1). People with unstable asthma or other lung disease were excluded.'Living Well with Asthma' is a desktop/laptop compatible interactive website designed with input from asthma/ behaviour change specialists, and adults with asthma. It aims to support optimal medication management, promote use of action plans, encourage attendance at asthma reviews and increase physical activity.Primary outcomes were recruitment/retention, website use, ACQ and mini-Asthma Quality of Life Questionnaire (AQLQ). Secondary outcomes included patient activation, prescribing, adherence, spirometry, lung inflammation and health service contacts after 12 weeks. Blinding postrandomisation was not possible.Recruitment target met. 51 participants randomised (25 intervention group). Age range 16-78 years; 75% female; 28% from most deprived quintile. 45/51 (88%; 20 intervention group) followed up. 19 (76% of the intervention group) used the website, for a mean of 18 min (range 0-49). 17 went beyond the 2 'core' modules. Median number of logins was 1 (IQR 1-2, range 0-7). No significant difference in the prespecified primary efficacy measures of ACQ scores (-0.36; 95% CI -0.96 to 0.23; p=0.225), and mini-AQLQ scores (0.38; -0.13 to 0.89; p=0.136). No adverse events.Recruitment and retention confirmed feasibility; trends to improved outcomes suggest use of Living Well with Asthma may improve self-management in adults with asthma and merits further development followed by investigation in a phase 3 trial.ISRCTN78556552; Results.

Project description:BackgroundThe self-management of osteoarthritis (OA) and low back pain (LBP) through activity and skills (SOLAS) theory-driven group-based complex intervention was developed primarily for the evaluation of its acceptability to patients and physiotherapists and the feasibility of trial procedures, to inform the potential for a definitive trial.MethodsThis assessor-blinded multicentre two-arm parallel cluster randomised controlled feasibility trial compared the SOLAS intervention to usual individual physiotherapy (UP; pragmatic control group). Patients with OA of the hip, knee, lumbar spine and/or chronic LBP were recruited in primary care physiotherapy clinics (i.e. clusters) in Dublin, Ireland, between September 2014 and November 2015. The primary feasibility objectives were evaluated using quantitative methods and individual telephone interviews with purposive samples of participants and physiotherapists. A range of secondary outcomes were collected at baseline, 6 weeks (behaviour change only), 2 months and 6 months to explore the preliminary effects of the intervention. Analysis was by intention-to-treat according to participants' cluster allocation and involved descriptive analysis of the quantitative data and inductive thematic analysis of the qualitative interviews. A linear mixed model was used to contrast change over time in participant secondary outcomes between treatment arms, while adjusting for study waves and clusters.ResultsFourteen clusters were recruited (7 per trial arm), each cluster participated in two waves of recruitment, with the average cluster size below the target of six participants (intervention: mean (SD) = 4.92 (1.31), range 2-7; UP: mean (SD) = 5.08 (2.43), range 1-9). One hundred twenty participants (83.3% of n = 144 expected) were recruited (intervention n = 59; UP n = 61), with follow-up data obtained from 80.8% (n = 97) at 6 weeks, 84.2% (n = 101) at 2 months and 71.7% (n = 86) at 6 months. Most participants received treatment as allocated (intervention n = 49; UP n = 54). The qualitative interviews (12 participants; 10 physiotherapists (PTs) found the intervention and trial procedures acceptable and appropriate, with minimal feasible adaptations required. Linear mixed methods showed improvements in most secondary outcomes at 2 and 6 months with small between-group effects.ConclusionsWhile the SOLAS intervention and trial procedures were acceptable to participants and PTs, the recruitment of enough participants is the biggest obstacle to a definitive trial.Trial registrationISRCTN ISRCTN49875385 . Registered on 26 March 2014.

Project description:IntroductionSelf-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the 'SupportBack' internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients.Methods and analysisA three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted.Ethics and disseminationThis trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy.Trial registration numberISRCTN14736486.

Project description:BackgroundThe Medical Research Council framework provides a useful general approach to designing and evaluating complex interventions, but does not provide detailed guidance on how to do this and there is little evidence of how this framework is applied in practice. This study describes the use of intervention mapping (IM) in the design of a theory-driven, group-based complex intervention to support self-management (SM) of patients with osteoarthritis (OA) and chronic low back pain (CLBP) in Ireland's primary care health system.MethodsThe six steps of the IM protocol were systematically applied to develop the self-management of osteoarthritis and low back pain through activity and skills (SOLAS) intervention through adaptation of the Facilitating Activity and Self-management in Arthritis (FASA) intervention. A needs assessment including literature reviews, interviews with patients and physiotherapists and resource evaluation was completed to identify the programme goals, determinants of SM behaviour, consolidated definition of SM and required adaptations to FASA to meet health service and patient needs and the evidence. The resultant SOLAS intervention behavioural outcomes, performance and change objectives were specified and practical application methods selected, followed by organised programme, adoption, implementation and evaluation plans underpinned by behaviour change theory.ResultsThe SOLAS intervention consists of six weekly sessions of 90-min education and exercise designed to increase participants' physical activity level and use of evidence-based SM strategies (i.e. pain self-management, pain coping, healthy eating for weight management and specific exercise) through targeting of individual determinants of SM behaviour (knowledge, skills, self-efficacy, fear, catastrophizing, motivation, behavioural regulation), delivered by a trained physiotherapist to groups of up to eight individuals using a needs supportive interpersonal style based on self-determination theory. Strategies to support SOLAS intervention adoption and implementation included a consensus building workshop with physiotherapy stakeholders, development of a physiotherapist training programme and a pilot trial with physiotherapist and patient feedback.ConclusionsThe SOLAS intervention is currently being evaluated in a cluster randomised controlled feasibility trial. IM is a time-intensive collaborative process, but the range of methods and resultant high level of transparency is invaluable and allows replication by future complex intervention and trial developers.

Project description:BackgroundLow back pain (LBP) is a common cause of disability and is ranked as the most burdensome health condition globally. Self-management, including components on increased knowledge, monitoring of symptoms, and physical activity, are consistently recommended in clinical guidelines as cost-effective strategies for LBP management and there is increasing interest in the potential role of digital health.ObjectiveThe study aimed to synthesize and critically appraise published evidence concerning the use of interactive digital interventions to support self-management of LBP. The following specific questions were examined: (1) What are the key components of digital self-management interventions for LBP, including theoretical underpinnings? (2) What outcome measures have been used in randomized trials of digital self-management interventions in LBP and what effect, if any, did the intervention have on these? and (3) What specific characteristics or components, if any, of interventions appear to be associated with beneficial outcomes?MethodsBibliographic databases searched from 2000 to March 2016 included Medline, Embase, CINAHL, PsycINFO, Cochrane Library, DoPHER and TRoPHI, Social Science Citation Index, and Science Citation Index. Reference and citation searching was also undertaken. Search strategy combined the following concepts: (1) back pain, (2) digital intervention, and (3) self-management. Only randomized controlled trial (RCT) protocols or completed RCTs involving adults with LBP published in peer-reviewed journals were included. Two reviewers independently screened titles and abstracts, full-text articles, extracted data, and assessed risk of bias using Cochrane risk of bias tool. An independent third reviewer adjudicated on disagreements. Data were synthesized narratively.ResultsOf the total 7014 references identified, 11 were included, describing 9 studies: 6 completed RCTs and 3 protocols for future RCTs. The completed RCTs included a total of 2706 participants (range of 114-1343 participants per study) and varied considerably in the nature and delivery of the interventions, the duration/definition of LBP, the outcomes measured, and the effectiveness of the interventions. Participants were generally white, middle aged, and in 5 of 6 RCT reports, the majority were female and most reported educational level as time at college or higher. Only one study reported between-group differences in favor of the digital intervention. There was considerable variation in the extent of reporting the characteristics, components, and theories underpinning each intervention. None of the studies showed evidence of harm.ConclusionsThe literature is extremely heterogeneous, making it difficult to understand what might work best, for whom, and in what circumstances. Participants were predominantly female, white, well educated, and middle aged, and thus the wider applicability of digital self-management interventions remains uncertain. No information on cost-effectiveness was reported. The evidence base for interactive digital interventions to support patient self-management of LBP remains weak.

Project description:BACKGROUND:Chronic pain can be complex and taxing to live with, and treatment and support require a multicomponent approach, which may not always be offered or available. Smartphones, tablets, and personal computers are already incorporated into patients' daily lives, and therefore, they can be used to communicate, educate, and support self-management. Although some web-based self-management interventions exist, research examining the evidence and effect of digital solutions supporting self-management for patients living with chronic pain is limited, findings are inconclusive, and new innovative ideas and solutions are needed. OBJECTIVE:This feasibility pilot study aimed to explore the system use, perceived usefulness, ease of use, and preliminary effects of EPIO, an app-based cognitive-behavioral pain self-management intervention program for patients living with chronic pain. METHODS:The EPIO intervention was delivered in a blended-care model containing (1) one face-to-face introduction session, (2) nine cognitive behavior-based pain self-management modules, delivered in an app-based format for smartphones or tablets, and (3) one follow-up phone call at 2 to 3 weeks after the introduction session. Patients living with chronic pain (N=50) completed pre-post outcome measures at baseline and 3 months after the introduction session, with registration of system use (ie, log data) until 6 months. The use, perceived usefulness, and ease of use of the EPIO program were examined through system use data, as well as a study-specific use/usability questionnaire and the System Usability Scale (SUS). Outcome measures to test feasibility of use and estimate preliminary effects included the Brief Pain Inventory, health-related quality of life (HRQoL) scale, Hospital Anxiety and Depression Scale, Self-Regulatory Fatigue scale, Pain Catastrophizing Scale, and Chronic Pain Acceptance Questionnaire. RESULTS:Participants (N=50) had a median age of 52 years (range 29-74 years) at inclusion and were mainly female (40/50, 80%). Thirty-one participants completed at least six of the nine modules within the 3-month study period (62% completion rate). Forty-five participants completed outcome measures at 3 months, and the EPIO program was rated as useful (ie, "totally agree" or "agree"; 39/45, 87%) and easy to use (42/45, 93%), and as having easily understandable exercises (44/45, 98%). The average overall system usability (SUS) score was 85.7, indicating grade A and excellent system usability. Preliminary psychosocial outcome measure estimates showed primarily nonsignificant pre-post intervention improvements at 3 months, but with significant positive effects related to some aspects of HRQoL (bodily pain, P=.02 and change, P=.049). CONCLUSIONS: Digital self-management intervention programs may be of use and support for patients living with chronic pain. In this feasibility study, EPIO showed an acceptable program completion rate and was rated as useful and easy to use, with excellent user satisfaction. Program optimization and efficacy testing in a large-scale randomized controlled trial are warranted and in progress. TRIAL REGISTRATION:ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104.

Project description:BackgroundClinical guidelines for management of low back pain (LBP) are not routinely implemented in practice, and guidelines rarely offer tools for implementation. Therefore, we developed GLA:D® Back, a standardised intervention of patient education and supervised exercises. This pilot study tested the feasibility of implementing GLA:D Back in clinical practice in Denmark by delivering a course for physiotherapists and chiropractors. It should further inform the planning of an implementation-effectiveness study using a pre-post group design alongside nation-wide implementation.MethodsThirty-one clinicians from nine clinics participated. Feasibility of implementation was evaluated in terms of adoption and through focus group interviews and a feedback meeting. Patient-level data, including pain, disability, and pain enablement, were collected from (1) LBP patients visiting the clinics during a pre-specified 2-week period 2 months prior to clinicians attending the GLA:D Back course (n?=?84), (2) LBP patients consulting during a 2-week period 2 months after the course (n?=?77), and (3) those enrolled in GLA:D Back during 4?months after implementation (n?=?89). Patient data were collected at baseline and at 4?months.ResultsClinicians' evaluations of the course were positive and resulted in several modifications. The clinical intervention was adopted by all test sites. Most patient characteristics were similar across groups. Patients mainly had persistent LBP (73% >?3?months) and most had been treated for more than 4 weeks at inclusion. Patients in GLA:D Back were more often retired (30% vs. 16% before implementation) and at high risk of poor prognosis (25% vs. 13%). Procedures for data collection were feasible, and outcomes after implementation, especially with GLA:D Back, were as good as or better than before implementation. Recruiting patients and achieving comparable pre- and post-groups was difficult.ConclusionsImplementation of the GLA:D Back clinical intervention in Danish primary care physiotherapy and chiropractic clinics was feasible through a 2-day clinician course. Both clinicians and patients were satisfied with the programme, and patient-reported outcomes were slightly better than outcomes in patients registered before implementation. It was not deemed possible to conduct an implementation-effectiveness trial as part of a nation-wide implementation.

Project description:BackgroundLow back pain (LBP) is a long-term health condition with an unpredictable pattern of symptomatic episodes, remission, and recurrence. Recently published systematic reviews suggest that exercise is the most effective intervention for preventing recurrences of LBP in persons that have recovered. Similar programs may also be effective in preventing flare-ups in persistent LBP. The aim of this study was to test the feasibility of the Back to Living Well program (Physical activity + Education + Self-management) developed to prevent recurrence or flare-ups of LBP. The study evaluated feasibility in terms of recruitment rate, adherence, satisfaction with the exercise and education sessions, and the data collection procedures. We also aimed to evaluate barriers and facilitators to the engagement in the program.MethodsSeventeen participants with non-specific LBP recently discharged from care from physiotherapy, chiropractors or physician care (< 3 months) were referred to the study by health care providers or community advertisements between December 2018 and February 2019. Participants underwent a 12-week (1 session/week) individualized, group-based exercise in the community and 4 sessions (30 min each) of education. All participants completed an action plan weekly for 12 weeks and wore an activity monitor for 6 months. All participants responded to weekly pain measures and completed study questionnaires at baseline, 3- and 6-months. Feasibility outcomes included recruitment, attrition rates and satisfaction. At the end of the intervention, participants completed an end-of-program survey.ResultsTwenty-nine participants were screened for eligibility; 20 were deemed eligible, while 17 were included over a 2-month period meeting our feasibility targets. In total, 16 completed follow-up study questionnaires at 3 months, and 15 completed the 6-month follow-up. Fourteen participants responded to weekly messages, while 3 participants reported not having a mobile device or Internet access. In total, 15 participants responded to our end-of-program survey. Average age was 54.9 (11.7); 9 were female (53%), and the mean duration of LBP was 62.9 (69.7) months. All satisfaction responses in relation to the exercise program, education program and data collection procedures reached our threshold of 70% out of 100%. Reported barriers to engagement in the program included fear of injury, lack of motivation and travel. Facilitators included proximity to home, low cost, flexible schedule and friendly location.ConclusionThe results show the program is feasible in terms of recruitment, low attrition, and patient satisfaction. Participants highlighted the excellent, relevant education program and the positive, personalized exercise. Future studies should evaluate the effectiveness of this intervention within a fully powered randomized controlled trial.Trial registrationNCT03328689.

Dataset Information

Using an internet intervention to support self-management of low back pain in primary care: findings from a randomised controlled feasibility trial (SupportBack).

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Using an internet intervention to support self-management of low back pain in primary care: findings from a randomised controlled feasibility trial (SupportBack).

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