Periodic Reporting for period 2 - COMPEL (COsts and Mechanisms of Personalised Exercise and Education for chronic Low back pain)
Período documentado: 2020-01-08 hasta 2021-01-07
Chronic low back pain is the leading cause of disability in Europe and worldwide. The societal costs are enormous, and this economic burden is predicted to increase as the EU population ages.
Exercise and education are both safe and effective options for back pain. The next step is to establish ways to increase the size of their effect. Personalised exercise and education has promise over existing ‘one size fits all’ exercise and education. Two randomised controlled trials (RCTs) by my research group (One in Norway and one trial led by me for my PhD in University of Limerick (n=208)) demonstrate that when exercise and education is tailored to the physical, lifestyle and psychological profile of each individual with CLBP, clinical outcomes are superior to ‘one size fits all’ therapies. Personalised exercise and education, delivered by a single clinician, appears a promising option for CLBP.
The objectives of COMPEL are:
1. To determine how personalised exercise and education reduces pain and disability in individuals with CLBP
2. To determine if there are individuals with CLBP who respond better or worse to personalised exercise and education
3. To investigate the cost-effectiveness of personalised exercise and education for CLBP
4. To disseminate and communicate results to the scientific community, clinicians, patients and policymakers
The action found that changing pain self-efficacy accounts for most of the benefit from personalised care; people of a lower socioeconomic status and poorer health do not respond as well to personalised care; and personalised care is cost effective compared to group care.
Exercise and education are both safe and effective options for back pain. The next step is to establish ways to increase the size of their effect. Personalised exercise and education has promise over existing ‘one size fits all’ exercise and education. Two randomised controlled trials (RCTs) by my research group (One in Norway and one trial led by me for my PhD in University of Limerick (n=208)) demonstrate that when exercise and education is tailored to the physical, lifestyle and psychological profile of each individual with CLBP, clinical outcomes are superior to ‘one size fits all’ therapies. Personalised exercise and education, delivered by a single clinician, appears a promising option for CLBP.
The objectives of COMPEL are:
1. To determine how personalised exercise and education reduces pain and disability in individuals with CLBP
2. To determine if there are individuals with CLBP who respond better or worse to personalised exercise and education
3. To investigate the cost-effectiveness of personalised exercise and education for CLBP
4. To disseminate and communicate results to the scientific community, clinicians, patients and policymakers
The action found that changing pain self-efficacy accounts for most of the benefit from personalised care; people of a lower socioeconomic status and poorer health do not respond as well to personalised care; and personalised care is cost effective compared to group care.
Objective 1. To determine how personalised exercise and education reduces pain and disability in individuals with CLBP
I performed a causal mediation analysis on my PhD trial data. My PhD trial was a multicentre randomised controlled trial, including 208 participants with CLBP in Ireland. It supported the effectiveness of personalised exercise and education for reducing disability, but not pain, compared to a group exercise and education intervention. I performed a causal mediation analysis to determine whether the effect of personalised exercise and education on disability and the lack of effect on pain (relative to a group exercise and education intervention) is influenced by certain psychological and lifestyle factors. I examined a number of possible influences (called mediators). These were: pain self-efficacy (confidence to manage one's pain), stress, fear of physical activity, coping, depression, anxiety, and sleep, at 6 months. The outcomes measured were functional disability and pain intensity at 12 months. I found that the majority of benefit of personalised exercise and education for disability is due to increasing pain self-efficacy. Personalised exercise and education did not improve the majority of the measured mediators (stress, fear of physical activity, coping, depression, anxiety and sleep) and these mediators were not associated with either disability or pain.
Objective 2. To determine if there are individuals with CLBP who respond better or worse to personalised exercise and education
I performed an exploratory secondary analysis of my PhD trial data. Moderators are factors measured prior to randomisation that affect whether an individual has a greater, or less benefit from treatment. For pain and disability, I found that low socioeconomic status and poorer general health (more subjective health complaints) was a moderator of treatment effect. I found that people of a lower socioeconomic standing and poorer general health responded better to personalised exercise and education compared to a group exercise and education intervention. I found no evidence that age, sex, duration of CLBP, risk of chronicity, or number of pain sites had a moderating effect on disability and pain.
Objective 3. To investigate the cost-effectiveness of personalised exercise and education for CLBP
I performed a cost analysis 6 and 12 months after initial randomisation to the two interventions. The aims of the analysis will be to identify, measure and compare individual costs incurred by the participants in both groups. Concomitant care, interventions and tests received, hospitalisations and tests, medications, equipment, aids and informal care, travel costs, employment status and work absenteeism were be assessed by a postal questionnaire at these follow-up times and statistical analyses compare differences between the two interventions.The provision of personalised exercise and education was cost-effective compared to a group-education programme but not superior.
Objective 4: To disseminate and communicate results to the scientific community, clinicians, patients and policymakers
During the outgoing phase, I first delivered a workshop on personalised exercise and education in my host institution to transfer the knowledge I had gained during my PhD in Ireland to the back pain researchers in Sydney. I presented the results of objective 1 and 2 at Wednesday seminars in my host institution in 2018 and 2019 and at a visit to La Trobe University in Melbourne in September 2019. I disseminated the results of objective 1 and 2 at 4 national and international conferences. These were the World Confederation of Physiotherapy Congress, May 10 - 13, 2019, Geneva, Switzerland, The Sydney Musculoskeletal Bone and Joint Health Alliance: 3th Annual Scientific Meeting 2019, July 30 - 31, 2019, University of Sydney, Australia, The 11th Congress of the European Pain Federation, Pain in Europe XI, September 4 - 7th, Valencia, Spain, and Preventing Overdiagnosis, December 5 - 7th, Sydney, Australia.
I was awarded Best Platform Presentation at the World Confederation of Physiotherapy Congress and The Lisa Schwartz Prize for best early career presentation at Preventing Overdiagnosis 2019.
During the incoming phase, i presented my research virtually at the European Pain Federation virtual summits. Other planned communication was hampered by COVID-19.
I performed a causal mediation analysis on my PhD trial data. My PhD trial was a multicentre randomised controlled trial, including 208 participants with CLBP in Ireland. It supported the effectiveness of personalised exercise and education for reducing disability, but not pain, compared to a group exercise and education intervention. I performed a causal mediation analysis to determine whether the effect of personalised exercise and education on disability and the lack of effect on pain (relative to a group exercise and education intervention) is influenced by certain psychological and lifestyle factors. I examined a number of possible influences (called mediators). These were: pain self-efficacy (confidence to manage one's pain), stress, fear of physical activity, coping, depression, anxiety, and sleep, at 6 months. The outcomes measured were functional disability and pain intensity at 12 months. I found that the majority of benefit of personalised exercise and education for disability is due to increasing pain self-efficacy. Personalised exercise and education did not improve the majority of the measured mediators (stress, fear of physical activity, coping, depression, anxiety and sleep) and these mediators were not associated with either disability or pain.
Objective 2. To determine if there are individuals with CLBP who respond better or worse to personalised exercise and education
I performed an exploratory secondary analysis of my PhD trial data. Moderators are factors measured prior to randomisation that affect whether an individual has a greater, or less benefit from treatment. For pain and disability, I found that low socioeconomic status and poorer general health (more subjective health complaints) was a moderator of treatment effect. I found that people of a lower socioeconomic standing and poorer general health responded better to personalised exercise and education compared to a group exercise and education intervention. I found no evidence that age, sex, duration of CLBP, risk of chronicity, or number of pain sites had a moderating effect on disability and pain.
Objective 3. To investigate the cost-effectiveness of personalised exercise and education for CLBP
I performed a cost analysis 6 and 12 months after initial randomisation to the two interventions. The aims of the analysis will be to identify, measure and compare individual costs incurred by the participants in both groups. Concomitant care, interventions and tests received, hospitalisations and tests, medications, equipment, aids and informal care, travel costs, employment status and work absenteeism were be assessed by a postal questionnaire at these follow-up times and statistical analyses compare differences between the two interventions.The provision of personalised exercise and education was cost-effective compared to a group-education programme but not superior.
Objective 4: To disseminate and communicate results to the scientific community, clinicians, patients and policymakers
During the outgoing phase, I first delivered a workshop on personalised exercise and education in my host institution to transfer the knowledge I had gained during my PhD in Ireland to the back pain researchers in Sydney. I presented the results of objective 1 and 2 at Wednesday seminars in my host institution in 2018 and 2019 and at a visit to La Trobe University in Melbourne in September 2019. I disseminated the results of objective 1 and 2 at 4 national and international conferences. These were the World Confederation of Physiotherapy Congress, May 10 - 13, 2019, Geneva, Switzerland, The Sydney Musculoskeletal Bone and Joint Health Alliance: 3th Annual Scientific Meeting 2019, July 30 - 31, 2019, University of Sydney, Australia, The 11th Congress of the European Pain Federation, Pain in Europe XI, September 4 - 7th, Valencia, Spain, and Preventing Overdiagnosis, December 5 - 7th, Sydney, Australia.
I was awarded Best Platform Presentation at the World Confederation of Physiotherapy Congress and The Lisa Schwartz Prize for best early career presentation at Preventing Overdiagnosis 2019.
During the incoming phase, i presented my research virtually at the European Pain Federation virtual summits. Other planned communication was hampered by COVID-19.
My projects are the first to examine how personalised exercise and education works for CLBP, and what individuals may respond best. The finding that pain-self efficacy mediates the treatment effect of personalised exercise and education on pain and disability has major implications for the management of CLBP. This is novel as treatments for CLBP often focus on physical and anatomical factors. Focussing on one's confidence to engage in self-management represents a paradigm shift in the management of CLBP. Giving individuals with CLBP the skills and confidence to engage in self-management will likely help reduce the costs and burden associated with the condition.
The finding that individuals with CLBP of a lower socioeconomic status and poorer general health may do better with personalised care compared to generic one size fits all interventions is relevant in light of the major problem of multimorbidity facing Europe. More often that not, individuals with CLBP will present with other pain and health complaints that may influence their CLBP outcomes. Our results may mean that more tailored treatment is required so the unique goals of each individual are addressed in an intervention. The results align more broadly with the wider literature that CLBP is a complex biopsychosocial problem with lots of interacting drivers.
The approach is cost-effective, but not cheaper, than usual care.
The finding that individuals with CLBP of a lower socioeconomic status and poorer general health may do better with personalised care compared to generic one size fits all interventions is relevant in light of the major problem of multimorbidity facing Europe. More often that not, individuals with CLBP will present with other pain and health complaints that may influence their CLBP outcomes. Our results may mean that more tailored treatment is required so the unique goals of each individual are addressed in an intervention. The results align more broadly with the wider literature that CLBP is a complex biopsychosocial problem with lots of interacting drivers.
The approach is cost-effective, but not cheaper, than usual care.