Facilitators and Barriers in Neuroscience-based Pain Education Programmes in Primary Care Physiotherapy

Fibromyalgia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05860816
• Other study ID #: CEIm 2925
• Status: Not yet recruiting
• Start date: May 12, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: May 2023
• Source: Castilla-León Health Service
• Contact: Paula Areso-Bóveda, PT
• Phone: +34629858714
• Email: pareso[@]saludcastillayleon.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 323
• Est. completion date: March 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Musculoskeletal Pain

Intervention

Other:
• Survey
Survey aimed at finding out the barriers and facilitators that Spanish primary care physiotherapists have to implement pain neuroscience-based education programmes in patients with chronic pain.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Castilla-León Health Service

References & Publications (17)

Areso-Boveda PB, Mambrillas-Varela J, Garcia-Gomez B, Moscosio-Cuevas JI, Gonzalez-Lama J, Arnaiz-Rodriguez E, Del Barco MBA, Teodoro-Blanco PS. Effectiveness of a group intervention using pain neuroscience education and exercise in women with fibromyalgia: a pragmatic controlled study in primary care. BMC Musculoskelet Disord. 2022 Apr 4;23(1):323. doi: 10.1186/s12891-022-05284-y. — View Citation

Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain. London: National Institute for Health and Care Excellence (NICE); 2021 Apr 7. Available from http://www.ncbi.nlm.nih.gov/books/NBK569960/ — View Citation

Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021 Dec 19;396(10267):2006-2017. doi: 10.1016/S0140-6736(20)32340-0. Epub 2020 Dec 1. Erratum In: Lancet. 2020 Dec 4;: — View Citation

Galan-Martin MA, Montero-Cuadrado F, Lluch-Girbes E, Coca-Lopez MC, Mayo-Iscar A, Cuesta-Vargas A. Pain neuroscience education and physical exercise for patients with chronic spinal pain in primary healthcare: a randomised trial protocol. BMC Musculoskelet Disord. 2019 Nov 3;20(1):505. doi: 10.1186/s12891-019-2889-1. — View Citation

Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018 Sep;27(Suppl 6):796-801. doi: 10.1007/s00586-017-5432-9. Epub 2018 Feb 26. — View Citation

King R, Robinson V, Elliott-Button HL, Watson JA, Ryan CG, Martin DJ. Pain Reconceptualisation after Pain Neurophysiology Education in Adults with Chronic Low Back Pain: A Qualitative Study. Pain Res Manag. 2018 Sep 12;2018:3745651. doi: 10.1155/2018/3745651. eCollection 2018. — View Citation

Korownyk CS, Montgomery L, Young J, Moore S, Singer AG, MacDougall P, Darling S, Ellis K, Myers J, Rochford C, Taillefer MC, Allan GM, Perry D, Moe SS, Ton J, Kolber MR, Kirkwood J, Thomas B, Garrison S, McCormack JP, Falk J, Dugre N, Sept L, Turgeon RD, Paige A, Potter J, Nickonchuk T, Train AD, Weresch J, Chan K, Lindblad AJ. PEER simplified chronic pain guideline: Management of chronic low back, osteoarthritic, and neuropathic pain in primary care. Can Fam Physician. 2022 Mar;68(3):179-190. doi: 10.46747/cfp.6803179. — View Citation

Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198. — View Citation

Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28. — View Citation

Mills S, Torrance N, Smith BH. Identification and Management of Chronic Pain in Primary Care: a Review. Curr Psychiatry Rep. 2016 Feb;18(2):22. doi: 10.1007/s11920-015-0659-9. — View Citation

Mills SEE, Nicolson KP, Smith BH. Chronic pain: a review of its epidemiology and associated factors in population-based studies. Br J Anaesth. 2019 Aug;123(2):e273-e283. doi: 10.1016/j.bja.2019.03.023. Epub 2019 May 10. — View Citation

Moseley GL, Butler DS. Fifteen Years of Explaining Pain: The Past, Present, and Future. J Pain. 2015 Sep;16(9):807-13. doi: 10.1016/j.jpain.2015.05.005. Epub 2015 Jun 5. — View Citation

Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-1982. doi: 10.1097/j.pain.0000000000001939. — View Citation

Sillevis R, Trincado G, Shamus E. The immediate effect of a single session of pain neuroscience education on pain and the autonomic nervous system in subjects with persistent pain, a pilot study. PeerJ. 2021 May 31;9:e11543. doi: 10.7717/peerj.11543. eCollection 2021. — View Citation

Stanton TR, Braithwaite FA, Butler D, Moseley GL, Hill C, Milte R, Ratcliffe J, Maher C, Tomkins-Lane C, Pulling BW, MacIntyre E, Esterman A, Stanford T, Lee H, Fraysse F, Metcalf B, Mouatt B, Bennell K. The EPIPHA-KNEE trial: Explaining Pain to target unhelpful pain beliefs to Increase PHysical Activity in KNEE osteoarthritis - a protocol for a multicentre, randomised controlled trial with clinical- and cost-effectiveness analysis. BMC Musculoskelet Disord. 2021 Aug 28;22(1):738. doi: 10.1186/s12891-021-04561-6. — View Citation

van Hecke O, Torrance N, Smith BH. Chronic pain epidemiology and its clinical relevance. Br J Anaesth. 2013 Jul;111(1):13-8. doi: 10.1093/bja/aet123. — View Citation

Van Oosterwijck J, Nijs J, Meeus M, Truijen S, Craps J, Van den Keybus N, Paul L. Pain neurophysiology education improves cognitions, pain thresholds, and movement performance in people with chronic whiplash: a pilot study. J Rehabil Res Dev. 2011;48(1):43-58. doi: 10.1682/jrrd.2009.12.0206. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between the characteristics of physiotherapists and their treatment approach in chronic pain.	Univariate logistic regression 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)	From May 2023 to November 2023
Secondary	Sample demographics	Descriptive statistics (mean, standard deviation, frequency) of age, gender, educational level and work experience.	From May 2023 to November 2023

External Links

•   the New Strategic Framework for PC of the Ministry of Health, Consumer Affairs and Social Welfare (2019) has among its objectives to strengthen community orientation, health promotion and prevention in PC.
•   Wilson et al are carrying out a study to detect the problems faced by physiotherapists practising freely in that country when applying interventions based on education in pain neuroscience.