Supporting self-management of low back pain with an internet intervention with and without telephone support in primary care (SupportBack 2): a randomised controlled trial of clinical and cost-effectiveness.

BACKGROUND: Low back pain is prevalent and a leading cause of disability. We aimed to determine the clinical and cost-effectiveness of an accessible, scalable internet intervention for supporting behavioural self-management (SupportBack). METHODS: Participants in UK primary care with low back pain without serious spinal pathology were randomly assigned 1:1:1 using computer algorithms stratified by disability level and telephone-support centre to usual care, usual care and SupportBack, or usual care and SupportBack with physiotherapist telephone-support (three brief calls). The primary outcome was low back pain-related disability (Roland Morris Disability Questionnaire [RMDQ] score) at 6 weeks, 3 months, 6 months, and 12 months using a repeated measures model, analysed by intention to treat using 97·5% CIs. A parallel economic evaluation from a health services perspective was used to estimate cost-effectiveness. People with lived experience of low back pain were involved in this trial from the outset. This completed trial was registered with ISRCTN, ISRCTN14736486. FINDINGS: Between Nov 29, 2018, and Jan 12, 2021, 825 participants were randomly assigned (274 to usual care, 275 to SupportBack only, 276 to SupportBack with telephone-support). Participants had a mean age of 54 (SD 15), 479 (58%) of 821 were women and 342 (42%) were men, and 591 (92%) of 641 were White. Follow-up rates were 687 (83%) at 6 weeks, 598 (73%) at 3 months, 589 (72%) at 6 months, and 652 (79%) at 12 months. For the primary analysis, 736 participants were analysed (249 usual care, 245 SupportBack, and 242 SupportBack with telephone support). At a significance level of 0·025, there was no difference in RMDQ over 12 months with SupportBack versus usual care (adjusted mean difference -0·5 [97·5% CI -1·2 to 0·2]; p=0·085) or SupportBack with telephone-support versus usual care (-0·6 [-1·2 to 0·1]; p=0·048). There were no treatment-related serious adverse events. The economic evaluation showed that the SupportBack group dominated usual care, being both more effective and less costly. Both interventions were likely to be cost-effective at a threshold of £20 000 per quality adjusted life year compared with usual care. INTERPRETATION: The SupportBack internet interventions did not significantly reduce low back pain-related disability over 12 months compared with usual care. They were likely to be cost-effective and safe. Clinical effectiveness, cost-effectiveness, and safety should be considered together when determining whether to apply these interventions in clinical practice. FUNDING: National Institute for Health and Care Research Health Technology Assessment (16/111/78).

Exploring Patients' Experiences of Internet-Based Self-Management Support for Low Back Pain in Primary Care.

OBJECTIVE: We explored patients' experiences of using Internet-based self-management support for low back pain (LBP) in primary care, with and without physiotherapist telephone guidance. DESIGN: Exploratory descriptive qualitative study using thematic analysis, nested within a randomized feasibility trial. METHODS: Patients with LBP who participated in a feasibility trial of the SupportBack Internet intervention (ISRCTN: 31034004) were invited to take part in semistructured telephone interviews after the three-month intervention period (a convenience sample from within the trial population). Fifteen participants took part (age range = 36-87 years, 66.7% female, characteristics representative of the trial population). Data were analyzed thematically. RESULTS: Analysis resulted in the development of six themes (subthemes in parentheses): Perceptions of SupportBack's design (Clarity and ease of use, Variety and range of information provided, Need for specificity and flexibility), Engaging with the SupportBack intervention, Promoting positive thought processes (Reassurance, Awareness of self-management), Managing behavior with SupportBack (Motivation and goal setting, Using activity as a pain management strategy, Preferences for walking or gentle back exercises), Feeling supported by telephone physiotherapists (Provision of reassurances and clarity, Physiotherapists are motivating), Severity and comorbidity as barriers (Preexisting condition or severity acting as a barrier, Less useful for mild low back pain). CONCLUSIONS: The Internet intervention SupportBack appeared to feasibly support self-management of LBP. Reassurance and ongoing support to implement behavioral changes were central to reported benefits. The addition of physiotherapist telephone support further enhanced the patient experience and the potential utility of the intervention.

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

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.

Investigations for radiculopathy: The patient perspective. A qualitative, interpretative inquiry.

BACKGROUND: Clinical guidelines recommend that investigations, such as magnetic resonance imaging, are offered only when likely to change management. Meanwhile, the optimal process of diagnosing radiculopathy remains uncertain and, in clinical practice, differences of opinion can occur between patient and clinician regarding the perceived importance of investigations. OBJECTIVES: To explore peoples' experiences of investigations and the effect of concordance between clinical presentation and investigation findings. METHODS: In this qualitative study, 14 participants who had recently undergone investigations for a clinical presentation of radiculopathy were purposively recruited from an NHS, Primary Care Service in the United Kingdom. Based on the principles of interpretative phenomenological analysis, individual, semi-structured interviews were recorded and transcribed verbatim. Data were managed using a framework approach and analysed thematically. FINDINGS: Although people reported wanting investigations to understand the cause of symptoms and inform management, access to them was reported to be difficult and protracted. When investigations revealed potentially relevant findings, people experienced relief, validation, empowerment and decisive decision-making. Disappointment emerged, however, regarding treatment options and waiting times, and long-term prognosis. When investigations failed to identify relevant findings, people were unable to make sense of their symptoms, relinquish their search to identify the cause, or to move forward in their management. CONCLUSIONS: This study provides the first reported in-depth interpretation of peoples' experience of undergoing investigations specifically for radiculopathy. Important implications have been identified for: investigation referral criteria; shared-decision-making; information sharing and managing expectations and disappointment. CLINICALTRIALS. GOV REFERENCE: UOS-2307-CR.

Opening clinical encounters in an adult musculoskeletal setting.

Effective communication between healthcare professionals and their patients is crucial for successful consultations, and can profoundly affect patients' adherence to treatment. Despite this evidence, communication within the physiotherapy profession is still underexplored, in particular, how 'best' to open clinical encounters. This study explores the issue by seeking the preferences of physiotherapists for opening encounters in the adult musculoskeletal outpatient setting. Initially, 42 consultations and 17 first follow-up encounters were observed between qualified physiotherapists and patients with back pain. These encounters were audio-recorded, analysed and used to develop a questionnaire to determine clinicians' preferences for opening encounters. From these findings, a synopsis of the questionnaire was posted on the four most-relevant professional networks of the national, interactive Chartered Society of Physiotherapy (iCSP) website, to canvass opinion more widely. Among the 43 physiotherapists who responded, the preferred 'key clinical question' for an initial encounter was: "Do you want to just tell me a little bit about [your 'problem presentation'] first of all?"; and for follow-up encounters: 'How have you been since I last saw you?' These results provide an important and novel contribution to the profession, as debate on this issue has not previously been published. Although the sample size in this study is small, the aim of this paper is to generate reflection and debate among clinicians on their preferences for opening patient encounters and optimising the non-specific treatment effects.

Measuring verbal communication in initial physical therapy encounters.

BACKGROUND: Communication in clinical encounters is vital in ensuring a positive experience and outcome for both patient and clinician. OBJECTIVE: The purpose of this study was to measure verbal communication between physical therapists and patients with back pain during their initial consultation and trial management of the data using a novel, Web-based application. DESIGN: A cross-sectional study was conducted. METHODS: Nine musculoskeletal physical therapists and 27 patients with back pain participated in this study. Twenty-five initial consultations were observed, audio recorded, and categorized using the Medical Communications Behavior System. Data were managed using Synote, a freely available application enabling synchronization of audio recordings with transcripts and coded notes. RESULTS: In this sample, physical therapists spoke for 49.5% of the encounter and patients for 33.1%. Providers and patients spent little time overtly discussing emotions (1.4% and 0.9%, respectively). More-experienced clinicians used more "history/background probes," more "advice/suggestion," and less "restatement" than less-experienced staff, although they demonstrated a greater prevalence of talking concurrently and interrupting patients (7.6% compared with 2.6%). LIMITATIONS: Although studies measuring actual behavior are considered to be the gold standard, audio recordings do not enable nonverbal behaviors to be recorded. CONCLUSION: This study investigated a method for measuring the verbal content of clinical encounters in a physical therapy outpatient setting. The study has directly contributed to developing a research-friendly version of the application (i.e., Synote Researcher). Given the pivotal role of communication in ensuring a positive experience and outcome for both patient and provider, investing time in further developing communication skills should be an on-going priority for providers. Further work is needed to explore affective behaviors and the prevalence of interrupting patients, considering differences in sex and provider experience.