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Chronic Primary PainNCT05860816

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

An observational study of Chronic Primary Pain and Musculoskeletal Pain, run by Castilla-León Health Service at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Survey
How many people
123 participants
Where
1 siteSpain
Study dates
12 May 2023to 31 Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Paula Areso

    Burgos, 09001

Other trials in Spain

About this study

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

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.

Read more

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.

Read the 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.

Being tested
Survey
Keywords
Primary Health Care, Chronic Pain, Physical Therapies Modalities, Health Education
Medical subject headings
Chronic Pain, Musculoskeletal Pain, Fibromyalgia, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurveyOther

    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.

Study groups in NCT05860816
Study groupRoleWhat they receive
Primary Care Physiotherapists working in the Spanish public health systemA sample of primary care physiotherapists fill out a survey on their knowledge of chronic pain management and the approach they use to treat patients with chronic pain.
Receives: Other: Survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: From May 2023 to November 2023

Secondary outcomes (1)
  1. Sample demographics

    Descriptive statistics (mean, standard deviation, frequency) of age, gender, educational level and work experience.

    Measured: From May 2023 to November 2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2023
  2. Study start12 May 2023
  3. Primary completion30 Dec 2023
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05860816
Sponsor's protocol ID
CEIm 2925
Status last verified
Feb 2025
First submitted
6 May 2023
Last updated
17 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31079836
  • 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.

    PubMed 32694387
  • 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.

    PubMed 33275908
  • 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.

    PubMed 23794640
  • 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.

    PubMed 26820898
  • 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.

    PubMed 29480409
  • 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/

    PubMed 33939353
  • 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.

    PubMed 35292455
  • 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.

    PubMed 22133255
  • 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.

    PubMed 27351541
  • 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.

    PubMed 34454458
  • 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.

    PubMed 26051220
  • 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.

    PubMed 21328162
  • 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.

    PubMed 34131526
  • 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.

    PubMed 30275918

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Primary Pain and Musculoskeletal Pain, run by Castilla-León Health Service at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Association between the characteristics of physiotherapists and their treatment approach in chronic pain. (time frame: From May 2023 to November 2023). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05860816, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.

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