Reductions in kinesiophobia and distress after pain neuroscience education and exercise lead to favourable outcomes: a secondary mediation analysis of a randomized controlled trial in primary care.

ABSTRACT: Pain neuroscience education combined with exercise (PNE + exercise) is an effective treatment for patients with chronic spinal pain. Yet, however, little is known about its underlying therapeutic mechanisms. Thus, this study aimed to provide the first insights by performing a novel mediation analysis approach in a published randomized controlled trial in primary care where PNE + exercise was compared with standard physiotherapy. Four mediators (catastrophizing, kinesiophobia, central sensitization-related distress, and pain intensity) measured at postintervention and 3 outcomes (disability, health-related quality of life, and pain medication intake) measured at 6-month follow-up were included into the analysis. The postintervention measure of each outcome was also introduced as a competing candidate mediator in each respective model. In addition, we repeated the analysis by including all pairwise mediator-mediator interactions to allow the effect of each mediator to differ based on the other mediators' values. Postintervention improvements in disability, medication intake, and health-related quality of life strongly mediated PNE + exercise effects on each of these outcomes at 6-month follow-up, respectively. Reductions in disability and medication intake were also mediated by reductions in kinesiophobia and central sensitization-related distress. Reductions in kinesiophobia also mediated gains in the quality of life. Changes in catastrophizing and pain intensity did not mediate improvements in any outcome. The mediation analyses with mediator-mediator interactions suggested a potential effect modification rather than causal independence among the mediators. The current results, therefore, support the PNE framework to some extent as well as highlight the need for implementing the recent approaches for mediation analysis to accommodate dependencies among the mediators.

Effectiveness of a Physical Therapeutic Exercise Programme for Caregivers of Dependent Patients: A Pragmatic Randomised Controlled Trial from Spanish Primary Care.

Female family caregivers (FFCs) constitute one of the basic supports of socio-health care for dependence in developed countries. The care provided by FFCs may impact their physical and mental health, negatively affecting their quality of life. In order to alleviate the consequences of providing care on FFCs, the Spanish Public Health System has developed the family caregiver care programme (FCCP) to be applied in primary care (PC) centres. The effectiveness of this programme is limited. To date, the addition of a physical therapeutic exercise (PTE) programme to FCCP has not been evaluated. A randomised multicentre clinical trial was carried out in two PC centres of the Spanish Public Health System. In total, 68 FFCs were recruited. The experimental group (EG) performed the usual FCCP (4 sessions, 6 h) added to a PTE programme (36 sessions in 12 weeks) whereas the control group performed the usual FCCP performed in PC. The experimental treatment improved quality of life (d = 1.17 in physical component summary), subjective burden (d = 2.38), anxiety (d = 1.52), depression (d = 1.37) and health-related physical condition (d = 2.44 in endurance). Differences between the groups (p < 0.05) were clinically relevant in favour of the EG. The experimental treatment generates high levels of satisfaction.

Pain Neuroscience Education and Physical Therapeutic Exercise for Patients with Chronic Spinal Pain in Spanish Physiotherapy Primary Care: A Pragmatic Randomized Controlled Trial.

Chronic musculoskeletal pain affects more than 20% of the population, leading to high health care overload and huge spending. The prevalence is increasing and negatively affects both physical and mental health, being one of the leading causes of disability. The most common location is the spine. Most treatments used in the Public Health Services are passive (pharmacological and invasive) and do not comply with current clinical guidelines, which recommend treating pain in primary care (PC) with education and exercise as the first-line treatments. A randomized multicentre clinical trial has been carried out in 12 PC centres. The experimental group (EG) conducted a program of pain neuroscience education (6 sessions, 10 h) and group physical exercise with playful, dual-tasking, and socialization-promoting components (18 sessions in 6 weeks, 18 h), and the control group performed the usual physiotherapy care performed in PC. The experimental treatment improved quality of life (d = 1.8 in physical component summary), catastrophism (d = 1.7), kinesiophobia (d = 1.8), central sensitization (d = 1.4), disability (d = 1.4), pain intensity (d = 3.3), and pressure pain thresholds (d = 2). Differences between the groups (p < 0.001) were clinically relevant in favour of the EG. Improvements post-intervention (week 11) were maintained at six months. The experimental treatment generates high levels of satisfaction.