My Back My Plan is a feasible and acceptable individualised program for acute low back pain in primary care

Keywords: acceptability, back pain, feasibility, general practice, integrated care, person-centred, physiotherapy, primary care.

Low back pain (LBP) is a complex, multidimensional condition (O’Sullivan et al. 2016; Hush 2020), and one of the leading causes of years lost to disability globally (Vos et al. 2020). There has been an urgent call to include LBP as a national health priority in Australia (Briggs and Dreinhöfer 2017). In Australia, as many as one-third of patients who receive primary care for acute LBP develop chronic pain (Henschke et al. 2008), which leads to a reduction in an individual’s quality of life and associated burden of disability (Australian Institute of Health and Welfare 2019). Back problems have been reported to lead to a loss of workforce, with nearly 144 000 Australians aged 45–64 years unable to work at substantial personal and national costs (Schofield et al. 2008). Further, research evaluating personal and economic costs of back problems in Australians with spinal disorders aged 45–64 years show that substantial costs include lost income and cost to the state from ‘lost income taxation, increased benefits payments, and lost gross domestic product (GDP) as a result of early retirement’ (Schofield et al. 2011, 2012). One cause of this high burden is that treatment of acute LBP is often ineffective, resulting in the development of disabling chronic pain (Henschke et al. 2008; Chou and Shekelle 2010). Therefore, one potential solution to this problem is to optimise treatment of LBP in the acute stage. An evidence synthesis in The Lancet revealed, there is a lack of high-quality evidence for treatment of acute LBP that results in a clinically worthwhile reduction in pain (Maher et al. 2017). This failure to achieve clinically worthwhile outcomes may be attributed to a failure to develop appropriate interventions utilising scholarly methodologies, continued testing of unimodal therapies and one-size-fits all treatments. Addressing these limitations may enable the development of treatments that are multimodal and person-centred, and based on rigorous methodologies.

My Back My Plan (MBMP) is a program for acute LBP that has been designed to address and overcome some of the limitations of existing interventions. It was developed using hybrid theoretical intervention-development frameworks, and co-designed for contextual refinement for delivery at MQ Health Primary Care at Macquarie University, Sydney, Australia (Ahern et al. 2022). The scholarly development and content of My Back My Plan has been described elsewhere (Ahern et al. 2022).

The aims of this study were to:

1. Evaluate the feasibility of delivering MBMP for acute LBP at MQ Health Primary Care.

2. Assess the participant-rated acceptability and usefulness of MBMP.

3. Investigate participant-reported changes in pain, recovery and function after completing MBMP.

This trial was a phase 1, single-group, pre–post intervention study. Ethical approval was obtained from the Macquarie University Human Research Ethics committee (Medical sciences) (Ref: 5201938387497) and clinical research governance authorisation was received from the Macquarie University Clinical Research Executive committee (Ref: MQCRG2018053). The study was registered with the Australian New Zealand Clinical Trials Registry (ANZCTRN12619000482167) and reporting followed the CONSORT 2010 checklist of information to include when reporting a pilot or feasibility trial (Eldridge et al. 2016).

MQ Health Primary Care at Macquarie University, Sydney, Australia.

People with acute LBP presenting to MQ Health Primary Care General Practice (GP) or Physiotherapy (PT) clinics between May 2019 and October 2019 were invited to participate in the study. Eligible participants were informed of the study by their treating clinicians at initial consultation, and consent was sought to provide contact details to the research team for further screening and enrolment. To be eligible, participants had to have: (1) acute (<12 weeks) LBP, (2) be at least 18 years old, and (3) have sufficient English literacy. LBP was defined as pain and discomfort, localised in the lumbar region below the costal margin and above the inferior gluteal fold, with or without referred leg pain. Participants were excluded from the study if there was: (1) suspicion of LBP due to specific pathology (e.g. nerve root compression) or serious disease (e.g. fracture, tumour, infection), or (2) had reported a previous episode of LBP in the past 6 months requiring health care. If participants were eligible and interested in participating in the study, the researcher arranged to meet them prior to their first study consultation, and written informed consent and demographics information via questionnaire were obtained from those who agreed to participate. This was completed prior to their initial appointment while they were in the waiting room, and delivered by a research team member (or research assistant). Participants were provided with a AUD50 gift voucher at the completion of the study for participating in the project.

General practitioners (GPs) and physiotherapists (PTs) employed by MQ Health Primary Care were recruited for the study. A member of the research team (or research assistant) sent an email to the MQ Health practice managers briefly outlining the purpose of the study and inviting GPs and physiotherapists to attend an information session about the study. Practitioners currently working in MQ Health Primary Care and treating patients presenting with LBP and were interested in participating in the study were invited to complete the participant information sheet and consent form. All clinicians who consented to participate completed the baseline and follow-up questionnaires during the trial. Training in the delivery of the program was provided in a 1-h group session or individually with clinicians prior to study enrolment. Online training resources were also available for clinicians. All clinicians who consented to participate completed the baseline and follow-up questionnaires during the trial.

MBMP is an individualised primary care program for acute LBP based on a comprehensive biopsychosocial assessment (Ahern et al. 2022). The aim of the intervention was to improve confidence in the management of LBP for both clinicians and patients.

The program was co-designed and developed using scholarly methods, and was contextualised for delivery at MQ Health Primary Care at Macquarie University in Sydney, Australia. A combination of assessment findings using the Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ; Linton et al. 2011) score and clinician identified contextual factors (including comorbidities, compensable injury, recurrences of LBP, lumbar spine range of movement and unhelpful thoughts/beliefs) were used to match the patient with the optimal MBMP treatment stream, using shared decision-making with the patient.

The streams were:

• MBMP Standard (up to four consultations over 2−3 weeks): ÖMPSQ <40 and few contextual factors,

• MBMP Plus (up to 10 consultations over 6 weeks): ÖMPSQ 40–65 and some contextual factors and

• MBMP Intensive (>10 consultations and psychology treatment over 6−12 weeks): ÖMPSQ >65 and many contextual factors.

The key principles and elements of the MBMP program are provided in Table 1. The program included standard GP consultations of approximately 15 min, and standard physiotherapy consultations of approximately 60 min for an initial appointment and 30–45 min for subsequent appointments. Participants were encouraged to self-manage after one or two consultations with the GP (diagnosis, imaging, medications, advice) and one or two sessions with the physiotherapist (goal setting, exercise, education, self-management skills), facilitated by an interactive Patient Booklet that was designed for this program. The development, principles and content of MBMP are described fully elsewhere (Ahern et al. 2022).

Table 1.  The seven principles and seven core elements of My Back My Plan (Ahern et al. 2022).

The primary outcomes of the trial were feasibility and acceptability of MBMP delivered at MQ Health Primary Care, which were assessed using structured questionnaires. Questionnaires were administered using the method preferred by the participants. Participants could complete the questionnaires online, via telephone with a research team member or in hard copy format, based on their own preference. Most preferred to complete an online survey or via phone interview.

Feasibility measures included: (1) feasibility of patient recruitment (assessed by examining the eligible, enrolled and retained participants as a proportion of people presenting to MQ Health Primary Care with acute onset LBP), (2) feasibility of intervention adherence (assessed by evaluating the matching of participants to treatment streams, and frequency and type of care sought), (3) clinician-rated acceptability of the program (assessed by evaluating responses on a three point scale [Yes, No, Unsure] about whether their confidence in managing acute LBP had improved and whether the program helped them manage participants within the constraints of clinical practice), (4) clinician-rated usefulness of key elements of the MBMP program (evaluated on a 7-point Likert rating scale [1 = Strongly disagree and 7 = Strongly agree]), and (5) safety (assessed by evaluating LBP flare-ups or other adverse events).

Participant-rated acceptability measures included: (1) acceptability of elements of MBMP (assessed by agreement with statements on a 7-point Likert scale [1 = Strongly disagree and 7 = Strongly agree]), (2) confidence in self-management (assessed by confidence ratings of self-managing current and future episodes of LBP on a 5-point Likert scale [1 = Really not confident and 5 = Really confident]), (3) application of self-management skills, and (4) likelihood to recommend MBMP (assessed on a 3-point scale [Very likely, Likely or Probably not] of how likely they were to recommend the program to another person).

In addition, qualitative feedback provided by participants in feasibility and acceptability questionnaires was collected at 1 month and 3 months post intervention.

Secondary outcome measures of this trial were three participant-reported clinical outcomes, evaluated at 1 month and 3 months, with pain severity also evaluated at baseline. The outcomes were: (1) pain severity (assessed as the average pain level in the last week measured on a 0−10 Numerical Pain Rating Scale (NRS; Downie et al. 1978; 0 = no pain and 10 = worst pain]), (2) recovery from LBP (measured with an 11-point Global Back Recovery Scale [5 = very much worse, 0 = no change, 5 = completely recovered; Hush et al. 2012), and (3) pain interference with function (assessed using a modified Brief Pain Inventory questionnaire, which has been validated in an LBP population; Keller et al. 2004). These secondary outcome measures were selected, as they are common primary outcomes of treatments for LBP, and are clinically relevant for both clinicians and people with LBP.

Characteristics of participants and feasibility data were analysed with descriptive statistics, reported as means (s.d.) or proportions (%). Qualitative feedback provided by participants in feasibility and acceptability questionnaires was analysed by identifying and summarising common themes. Secondary participant-reported outcomes were also analysed descriptively. Changes in pain severity from baseline to 1 month and baseline to 3 months and recovery from LBP from 1 to 3 months for recovery from LBP were calculated using paired t-tests in SPSS (IBM SPSS Statistics for Windows, V 25.0; IBM Corporation, Armonk, NY, USA) as the within-group mean change (95% confidence interval).

Fourteen participants were recruited between May 2019 and October 2019; 79% and 93% were followed up at 1 and 3 months respectively (Fig. 1). No participant cited the intervention as the reason for discontinuing participation.

Fig. 1.  Flow of participants through the trial. GP, general practitioner; LBP, low back pain; PT, physiotherapy. *Red flags defined as suspicion of LBP due to specific pathology or serious disease.

The characteristics of the participants are outlined in Table 2. The mean duration of LBP was 20.6 (s.d. 17.5) days with an average pain severity of 6.2 (s.d. 1.6). Half of the participants were rated as having a medium risk of a poor outcome based on their ÖMPSQ score.

Table 2.  Characteristics of participants.

Fourteen clinicians were recruited to this study: 71% were GPs and 29% were PTs. The characteristics of the participating clinicians are outlined in Table 3. The majority (70%) had seen over 10 people with LBP during the past year.

Table 3.  Characteristics of clinicians.

The rate of patient recruitment from MQ Health Primary Care to the trial was low. Of the 149 people presenting with LBP to either the GP clinic or PT clinic during the 6-month recruitment period, only 44 were referred for recruitment (Fig. 1). Barriers to recruitment identified by clinicians included: lack of time, lack of interest, forgetting to mention the trial and comorbidities that indicated other treatment pathways. Of the 44 participants referred to the study, 14 patients (32%) consented and were enrolled (Fig. 1).

All participants received an initial assessment, including baseline ÖMPSQ scoring. Thirteen out of 14 participants (93%) were matched to the appropriate treatment stream based on their ÖMPSQ score and contextual factors (Ahern et al. 2022), with one participant unable to return to their GP following initial consultation in the 3-month period. Interestingly, four participants had ÖMPSQ scores of >65, indicating possible allocation to the MBMP Intensive stream. However, three of these were allocated to the MBMP Plus program based on their individual preferences, indicating adherence to the shared decision-making principle. The other participant was not allocated to a specific MBMP program level and did not return for care. All participants received the Patient Booklet resource, which was developed specifically for MBMP, as per protocol.

The average number of sessions attended with GP at 3 months was 1.9 (s.d. 3.0) and physiotherapist was 2.6 (s.d. 3.7). Overall, adherence with the interdisciplinary aspect of the intervention was 57%, with eight out of 14 participants seeking care from more than one clinician type. The number of consultations for each clinician type seen for the current episode of care is reported in Table 4.

Table 4.  Number of consultations for each clinician type seen for current episode of care.

Half of the clinicians reported they were more confident in managing patients presenting with acute LBP after trialling MBMP; 43% of clinicians reported MBMP was helpful in managing patients. Half of the clinicians also reported they were very likely to continue using MBMP in primary care.

Aspects of the program that clinicians rated as being useful (Fig. 2) included patient education and the Patient Booklet. Two-thirds of clinicians agreed that the interdisciplinary aspect of the MBMP program worked well, and almost 80% of clinicians reported that this program facilitated person-centred care.

Fig. 2.  Clinicians’ rating of the usefulness of specific aspects of the MBMP program. Note: there were no ratings of Slightly disagree, Disagree and Strongly disagree. MBMP, My Back My Plan.

One participant did not return for care following the initial appointment and was not allocated to a specific MBMP program level.

No major adverse events occurred during the intervention period. During the 3-month follow-up, six participants (46%) experienced fluctuations/recurrence of LBP and reported muscle soreness. None reported loss of time from study or work. Only one participant who experienced a recurrence sought care from their clinician.

Overall, participants rated MBMP as highly acceptable (Fig. 3). At 3 months follow up, the majority of participants (85%) agreed they had a better understanding of LBP due to the program and that the Patient Booklet was helpful (77%). All participants agreed or strongly agreed that they were given a personalised program for their acute LBP.

Fig. 3.  Participant-reported acceptability ratings of specific aspects of the MBMP program at 1 month and 3 months. Note: there were no ratings of Slightly disagree, Disagree and Strongly disagree. LBP, low back pain; MBMP, My Back My Plan.

At the 3 months follow-up, all participants reported they were confident (62%) or really confident (38%) to self-manage their LBP. A high proportion (92%) were also confident about knowing how to prevent future episodes following the MBMP program. Approximately half the participants were really confident (46%) about when to seek further treatment.

All participants reported using active self-management (such as movement, exercise or stretches) at the 3-month follow-up (Table 5). Additionally, 38% of patients reported making lifestyle changes (such as time management, weight loss, attend gym) to better manage their LBP. Additional self-management strategies that were commonly used included changing posture regularly, utilising educational resources and relaxation techniques.

Table 5.  Self-management strategies participants reported applying for their low back pain.

At the 3-month follow-up, the majority (85%) of participants stated they were very likely to recommend the MBMP program.

At baseline, the participants reported a moderately high average pain severity during the past week, with a mean of 6.2 (s.d. 1.6) on the 0–10 NRS. At 1 month, the mean pain rating had decreased by 3.3 (95% CI 1.3–5.3), and at 3 months by 4.3 (95% CI 3.2–5.4).

All participants reported some degree of recovery from their LBP. The mean recovery rating was 3.7 (s.d. 1.0) at 1 month, and 4.2 (s.d. 0.7) at 3 months on the 11-point scale (−5 to +5).

Patients rated the interference of their LBP on daily activities much lower at 3 months compared with 1 month (Fig. 4). Improvements were observed on all aspects of function, with the largest gains in ability to complete normal work duties (including paid or housework) and general activity.

Fig. 4.  Participant-reported pain interference with function (modified Brief Pain Inventory scale, 0–10, where 0 = no pain and 10 = pain as bad as you can imagine) at 1 and 3 months after commencing My Back My Plan.

This study demonstrates that patients experienced MBMP as highly acceptable, and that as a result of receiving personalised primary care, they perceived they had a better understanding of LBP and self-management. For clinicians, approximately half reported positive acceptability outcomes, such as having greater confidence in managing people with acute LBP and, importantly, that they were likely to continue applying MBMP in routine primary care of patients with LBP. Many aspects of the feasibility evaluation were favourable, including clinician-rated usefulness of the MBMP program, particularly in facilitating patient education and person-centred care. Participant-reported outcomes were promising. Importantly, there were no major adverse events or safety issues during the intervention period, and high levels of participant retention were achieved following recruitment.

However, the major challenge in this trial was the feasibility of recruiting participants into the study. Only 10% of those presenting with LBP were enrolled, with 50 potential participants not screened by clinicians. Barriers to recruitment identified by clinicians included lack of time to discuss the trial with the patient, failure to recall the trial and participants having comorbidities that required prioritised treatment during the consultation period. Previous research by Bower et al. (2009) on barriers to recruitment to health research in primary care has reported several attitudinal and logistical barriers related to the characteristics of primary care clinicians and patients, and the complex nature of primary care settings. Some clinician barriers reported in this study included practical and logistical issues, attitudes to treatment and condition being treated, effects of doctor–patient relationship, incentives, work pressures, technical difficulties to recruitment process, lacking skills or confidence to introduce research, treatment preferences, and relationship with academics (Bower et al. 2009). Potential solutions to these barriers could include greater visibility in the clinics and consultation rooms of information about the program, including flyers that explain MBMP for GPs and PTs to give to LBP patients. To overcome problems with busy clinicians forgetting to screen patients, electronic reminders could be implemented into practice systems. Clearly, such approaches would need to be tailored to individual clinics to integrate with existing systems as smoothly as possible. The issue of comorbidities is complex: although MBMP is designed for patients who do not have serious or specific pathology requiring specialised treatment (Ahern et al. 2022), it is not uncommon for more serious comorbidities to require care for those conditions as a priority above their LBP (Ramanathan et al. 2018). Indeed, feedback from clinicians in our study was that LBP is rarely a ‘pure’ syndrome, but is often influenced by comorbid factors. These considerations are a reminder that excellence in evidence-based clinical care always requires integration of the clinician’s judicious decision-making, together with the patient’s preferences and best available evidence (Sackett et al. 1996) further supporting the principles of individualised and person-centred care featured in this program.

The feasibility trial also revealed that slightly more than half of participants received interdisciplinary treatment. Cost and inconvenience were identified as common barriers to interdisciplinary care. Some participants reported their preference to see a single clinician if they had been provided adequate advice and education on self-management in the initial consultation. These participants also reported high levels of confidence in their treating clinician, reflecting the importance of a strong therapeutic alliance in a ‘good back-consultation’ (Laerum et al. 2006). The issues of high costs being a barrier to effective treatment, poor therapeutic alliance and lack of patient centred care have also been highlighted in a recent Australian survey (Ahern et al. 2019).

Although the design of this feasibility trial precludes any conclusions about treatment effectiveness, the observation that clinical outcomes improved throughout the program are encouraging. Specifically, pain severity reduced by amounts that LBP patients consider clinically worthwhile (Ferreira et al. 2009), self-rated recovery from LBP was high and pain interference with daily activities was reduced. These improvements were observed at 1 month after commencing the program and were sustained at the 3-month follow-up.

One important limitation of the current study is that we did not specify a priori criteria for feasibility or acceptability, and the size of the sample in which we intended to see these criteria met. This means that our conclusions need to be treated with caution, and further research is required to support decisions on whether to proceed to a future definitive randomised controlled trial. However, this initial exploratory study can provide information that can guide the development of a priori criteria and sample sizes for future studies.

In conclusion, although the sample size of this trial was low, this phase I feasibility study suggests that the co-designed, contextually refined MBMP program for MQ Health Primary Care is acceptable to people with acute-onset LBP. Participants developed and applied effective self-management strategies from the program, and a high proportion stated they would recommend the MBMP program to others. Improvement of recruitment (for example, electronic reminders to clinicians for screening) would be a useful focus for further development and evaluation of this primary care program for acute LBP.

The data that support this study will be shared upon reasonable request to the corresponding author.

The authors declare no conflicts of interest.

MA was funded by a Macquarie University Research Training Program (RTP) full-time PhD scholarship. BFD was supported by a National Health and Medical Research (NHMRC) Emerging Leadership Fellowship and is part of a team funded by the Australian Federal Government to develop and provide a free national online assessment and treatment service, the MindSpot Clinic, for Australians with anxiety and depression. The sources of support to MA and BFD had no involvement in the decision to submit the final manuscript for publication.