Exploring What Factors Mediate Treatment Effect: Example of the STarT Back Study High-Risk Intervention

Mansell, Gemma; Hill, Jonathan; Main, Chris J.; Vowles, Kevin E.; Windt, D.A.W.M. van der

doi:10.1016/j.jpain.2016.08.005

Cited by 46 publications

(54 citation statements)

References 53 publications

(53 reference statements)

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“…Although several studies have shown significant mediating effects of psychological factors such as catastrophizing (Spinhoven et al 2004;Smeets et al 2006;Hall et al 2016), fear avoidance (Mansell et al 2016a;Fordham et al 2017;Whittle et al 2017), pain self-efficacy (Fordham et al 2017) and pain related distress (Mansell et al 2016b) on LBP outcomes, only one previous study has investigated physical factors, showing that frequency and engagement with every day activities mediated the effect of a CBT programme on disability (Fordham et al 2017). As physical factors such as muscle strength (Taylor et al 2014), physical activity (Heneweer et al 2011) and sleep (Kelly et al 2011;Alsaadi et al 2014) have been linked to the development/prognosis of LBP we are unsure as to why physical factors have been largely ignored.…”

Section: Comparisons With Other Studiesmentioning

confidence: 99%

Mechanisms for reducing low back pain: a mediation analysis of a multifaceted intervention in workers in elderly care

Stevens

Boyle

Hartvigsen

et al. 2018

Int Arch Occup Environ Health

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Section: Comparisons With Other Studiesmentioning

confidence: 99%

Mechanisms for reducing low back pain: a mediation analysis of a multifaceted intervention in workers in elderly care

Stevens

Boyle

Hartvigsen

et al. 2018

Int Arch Occup Environ Health

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“…A mediation analysis quantifies the causal mechanisms by dividing the causal effect of the intervention on the outcome into the indirect effect (the effect which acts through a hypothesized mediator) and direct effect (total effect minus the indirect effect; Lee et al, 2019). Available mediation analyses have shown that interventions including exercise (Smeets, Vlaeyen, Kester, & Knottnerus, 2006), graded exposure, graded activity (Leeuw et al, 2008), cognitive behavioural therapy (Smeets et al, 2006), the STarT back approach, (Mansell, Hill, Main, Vowles, & Van Der Windt, 2016) and multidisciplinary treatment, (Spinhoven et al, 2004) can reduce disability and pain in individuals with CLBP, through changes in catastrophizing (Hall, Kamper, Emsley, & Maher, 2016;Leeuw et al, 2008;Mansell et al, 2016;Smeets et al, 2006;Spinhoven et al, 2004), pain-self-efficacy, pain-related stress and pain intensity (Mansell et al, 2016;Smeets et al, 2006;Spinhoven et al, 2004). While a number of mediation trials for CLBP have been conducted (Lee et al, 2016), none have specifically involved the analysis of CFT.…”

Section: Introductionmentioning

confidence: 99%

Examining what factors mediate treatment effect in chronic low back pain: A mediation analysis of a Cognitive Functional Therapy clinical trial

O’Neill

O’Sullivan

et al. 2020

European Journal of Pain

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Background Cognitive Functional Therapy (CFT) is a physiotherapist‐led individualized intervention for people with people with non‐specific chronic low back pain (CLBP), involving biopsychosocial pain education, graded movement exposure and lifestyle coaching. Methods A multicentre randomized controlled trial (RCT), including 206 participants with CLBP in Ireland, supported CFT’s effectiveness for reducing disability, but not pain, compared to a group exercise and education intervention. In this study, causal mediation analysis was used to determine whether the effect of CFT on disability and the lack of effect on pain (relative to a group exercise and education intervention) is mediated by certain psychological and lifestyle factors. Hypothesized mediators measured were pain self‐efficacy, 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. Results This causal mediation study shows that the majority of benefit of CFT (relative to a group exercise and education intervention) for disability is due to increasing pain self‐efficacy. Conclusion Conclusion: CFT did not improve the majority of the hypothesized mediators (stress, fear of physical activity, coping, depression, anxiety and sleep) and these mediators were not associated with either disability or pain. Unfortunately, the proportion of missing data in this study is substantial and these findings can only be considered hypothesis‐generating. Therefore, future research should examine replicating the results of this study to verify the role of self‐efficacy and other proposed mediators (e.g. stress, coping, sleep, fear) on clinical outcomes. Significance An exploration of seven potential mediators was undertaken to determine the effect of Cognitive Functional Therapy (CFT) on disability and pain intensity in individuals with chronic low back pain compared to a group exercise and education intervention. CFT improved pain self‐efficacy, which was associated with disability and pain outcomes. CFT did not improve the other six potential mediators (stress, fear of physical activity, coping, depression, anxiety and sleep) and these were not associated with disability or pain. The proportion of missing data in this study is substantial and these findings should be considered hypothesis‐generating only.

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“…Increasingly, psychological factors have been considered alongside physical factors in musculoskeletal pain [7][8][9][10]. Currently there exists limited evidence to indicate that some with PFP have higher levels of catastrophising and poorer patient-reported general mental health than controls [11].…”

Section: Introductionmentioning

confidence: 99%

The psychological features of patellofemoral pain: a cross-sectional study

Maclachlan

Matthews

Hodges

et al. 2018

Scandinavian Journal of Pain

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Abstract Background and aims: Patellofemoral pain (PFP) is a prevalent and debilitating musculoskeletal condition, considered to have a mechanical aetiology. As such, the physical impairments associated with PFP are well documented and have helped characterise different physical phenotypes. But little is known about the relationship between PFP and psychological well-being. In this study, we aimed to: (1) compare psychological profiles between groups with and without PFP; (2) compare psychological profiles and condition severity between PFP subgroups; and (3) explore relationships between psychological factors and their contribution to disability. We expected to find higher levels of psychological impairment, especially kinesiophobia and catastrophizing in the PFP group. We also expected to identify a sub-group for who worsening levels of disability correspond with worsening psychological well-being. Methods: One hundred participants with PFP (72 females, mean±SD age 27±5 years, BMI 25.3±4.8 kg/m2) completed measures of pain, disability, and psychological features (kinesiophobia, catastrophizing, anxiety and depression). Fifty controls, matched by sex, age and activity level (36 females, age 27±5 years, BMI 22.9±4.5 kg/m2) also completed psychological measures. The Knee injury and Osteoarthritis Outcome Score (KOOS) was used to cluster PFP participants (K-means cluster analysis) into more and less severe sub-groups. Differences between the control and PFP groups were analysed using t-tests, analysis of variance, Mann-Whitney U-tests or χ2 tests as appropriate (p<0.05). Pearson correlations were used to explore relationships between psychological measures. Backward stepwise regression (p out >0.05) evaluated how the psychological factors potentially relate to disability. Results: Psychological features did not differ between PFP and pain-free groups. But differences were apparent when the PFP cohort was subgrouped. Compared to controls, the more-severe group had significantly higher levels of depression (MD 1.8, 95% CI 0.8–2.8; p≤0.001) and catastrophizing (MD 5.7, 95% CI 2.4–9; p≤0.001). When compared to less-severe cases, the more-severe group also demonstrated significantly higher levels of kinesiophobia (MD 4.3, 95% CI 2.1–6.5; p≤0.001), depression (MD 1.5 95% CI 0.5–2.6; p=0.01) and catastrophizing (MD 4.9, 95% CI 1–8.8; p=0.01). The weakest relationship between psychological factors was found between kinesiophobia and anxiety (r=0.29; p=0.02). While the strongest relationship existed between depression and anxiety (r=0.52; p≤0.001). Both kinesiophobia (β −0.27, 95% CI −0.265 to −0.274) and depression (β −0.22, 95% CI −0.211 to −0.228) were associated with disability as defined by the KOOS in the regression model (R2=0.17, p≤0.001). Conclusions: Those with more-severe PFP-related disability have higher levels of psychological impairment than less-severe cases. Kinesiophobia seems to stand as an important factor in the experience of PFP, because it was elevated in the PFP group, significantly differed between the PFP sub-groups and contributed to explaining disability. Contrary to our hypothesis, levels of catastrophizing in the PFP group and severe sub-group were low and seemingly not important. Implications: These findings draw attention to psychological factors to which clinicians assessing PFP should show vigilance. They also highlight psychological impairments that might be worthwhile targets in optimising PFP management.

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Exploring What Factors Mediate Treatment Effect: Example of the STarT Back Study High-Risk Intervention

Cited by 46 publications

References 53 publications

Mechanisms for reducing low back pain: a mediation analysis of a multifaceted intervention in workers in elderly care

Mechanisms for reducing low back pain: a mediation analysis of a multifaceted intervention in workers in elderly care

Examining what factors mediate treatment effect in chronic low back pain: A mediation analysis of a Cognitive Functional Therapy clinical trial

The psychological features of patellofemoral pain: a cross-sectional study

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