Clinical trial NCT05860816: Facilitators and Barriers in Neuroscience-based Pain Education Programmes in Primary Care Physiotherapy
Official title: Facilitators and Barriers to Implementing Pain Neuroscience Education Programmes for the Treatment of Patients With Chronic Pain in Primary Care Physiotherapy Units: the Physiotherapist's Perspective
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Primary Pain
Musculoskeletal Pain
Fibromyalgia
Keywords: Primary Health Care
Chronic Pain
Physical Therapies Modalities
Health Education
Lead sponsor: Castilla-León Health Service
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants must meet the following inclusion criteria: a) be a physiotherapist working in a primary care setting; and b) have more than 2 years of work experience in this clinical setting. Participants who do not work in the public sector will be excluded from the study.

Brief summary: The new approach in pain neuroscience education (PNE) requires specific training for the physiotherapists in charge of applying it. In recent years, public and private initiatives have offered training in different formats, online courses, face to face courses, congresses, that have facilitated access to this knowledge for many professionals. However, this offer lacks a sufficiently deep approach, so that physiotherapists do not develop the necessary skills to put it into practice, in addition to being an area of knowledge in which the concepts need constant updating given the rapid scientific progress.

As with any paradigm shift, there is resistance to change on the part of some professionals, but the extent to which this has a collective impact on the generalization of these interventions is unknown.

From our point of view, lack of training is only one of the aspects that hinder the implementation of PNE. Working conditions (pressure of care, high physiotherapist/population ratios, limited time available) and organizational conditions (dependence on hospital services, lack of vision of this model by the PC team) could be among the main daily difficulties in implementing it.

The main objective of this study is to detect the barriers and facilitators that primary care physiotherapists have to implement programmes based on the new paradigm of pain neuroscience in the treatment of patients with chronic pain.

Detailed description: Introduction: Chronic pain is a complex clinical entity with a growing impact on population health. In the Global Burden of Disease 2019 study, pain and pain-related diseases were the leading cause of disability worldwide, with musculoskeletal problems being the most prevalent. According to the International Association for the Study of Pain (IASP), pain can be defined as "an unpleasant sensory and emotional experience associated with, or similar to that associated with, actual or potential tissue damage". This definition tries to include the different dimensions of pain, evolving from survival-oriented nociceptive pain to neuropathic or neuroplastic pain, more related to processes of central sensitisation, inhibition of downstream modulators or temporary summation of stimuli.

Due to its multidimensional nature, pain management is complex and requires frequent assessments to adjust the interventions needed to maintain the quality of life of individuals. Current scientific evidence supports the implementation of primary care programmes based on pain neuroscience education and therapeutic exercise for chronic pain management. The rationale for these interventions is based on autonomous management of the disease by the patient, through increased knowledge of the neurophysiology of pain, improved functional capacity and an addressing of the psychosocial factors involved. Primary care physiotherapists have been shown to play a key role in the management of chronic pain at community level through the development of such programmes.

However, the implementation of these programmes is a clinical challenge due to the lack of knowledge of the approach to chronic pain, the need for specialised training or the provision of resources by health systems. The aim of this study is to identify facilitators and barriers from the point of view of primary care physiotherapists to implement chronic pain management through primary care programmes based on education and therapeutic exercise.

Study design: A cross-sectional observational study will be carried out in primary care physiotherapists in the Spanish national health system. The survey to be used will be an adaptation to Spanish of the one developed by Wilson et al. Study participants should meet the following inclusion criteria: a) be a physiotherapist working in a primary care setting; and b) have more than 2 years of experience in this context. Not working in the public sector will be considered an exclusion criterion.

Potential participants will be contacted through the nursing directors of each health area (an administrative division of the Spanish health system). Participation will also be promoted through social networks. Information about this study will be also available at the IV National Conference on Physiotherapy in Primary Care, to be held on May 12 and 13, 2023 in Barcelona (Spain).

Variables: Independent variables will be: 1) current situation of the primary care physiotherapist (working conditions), 2) training in pain neuroscience, 3) barriers to implementing the approach and 4) available resources. Dependent variables will be: 1) clinical approach used in the management of chronic pain; and 2) Interventions used by the primary care physiotherapist in the treatment of people with chronic pain.

Data collection: The survey will be administered through Google Forms. Participants will receive information on the basic aspects of the study and will sign an informed consent form before taking the survey. The sample size was set at 323 participants considering a confidence level of 95%, an standard deviation of .5, and a margin of error of 土5%.

Data analysis: Survey data will be exported into Excel for cleaning, then transferred to SPSS (v26, IBM Corp., New York, USA) for analysis. Descriptive statistics (mean, standard deviation, frequency) will be used to summarise demographic/survey data. Univariate logistic regression will examine associations between the training of physiotherapists, the barriers experienced, their clinical setting and their available resources (independent variables) and their competency/use of an approach based on pain neuroscience education (dependent variables). For continuous outcomes, univariate linear regression will be used. Multivariate regressions will be used if relevant covariates exist (identified via p\<0.10 in univariate regression analysis). Where appropriate, content or thematic analysis will ensure transparent synthesis of open-ended question data. Themes will be identified via answer coding line-by-line if applicable. Only responses with ≥80% of the data completed will be included.

Eligibility criteria: Inclusion Criteria:

* Primary Care Physiotherapists in the Spanish national health system with more than two years of experience.

Exclusion Criteria:

* Less than two years of experience in Primary Care
* Do not work in the public system

Primary outcomes:
measure: Association between the characteristics of physiotherapists and their treatment approach in chronic pain.
timeFrame: From May 2023 to November 2023
Secondary outcomes:
measure: Sample demographics
timeFrame: From May 2023 to November 2023
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Paula Areso
Study officials:
name: Goretti Aranburu-Guenaga, PT
role: STUDY_CHAIR
affiliation: University of South Australia
name: Tasha Stanton, MSc, PhD
role: STUDY_CHAIR
affiliation: University of South Australia
name: Felicity A Braithwaite, PhD
role: STUDY_CHAIR
affiliation: University of South Australia
name: Monique Wilson, PhD C
role: STUDY_CHAIR
affiliation: Servicio de salud de Castilla y León (SACYL)
name: Paula Areso-Bóveda, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valladolid
name: Héctor Hernández-Lázaro, PT
role: STUDY_CHAIR
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