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The (cost-)effectiveness of an innovative, personalised intervention of therapeutic VirtuAl Reality IntEgrated within physioTherapY for a group of complex chronic low back pain patients (VARIETY-study)

Projectomschrijving

Fysiotherapie met therapeutische virtual reality voor mensen met ernstige chronische lage rugpijn: een gerandomiseerd gecontroleerd onderzoek (VARIETY-studie)

Mensen met langdurige (chronische) lage rugklachten blijken slechts een klein effect te hebben van fysiotherapie. Deze effecten zijn nog kleiner wanneer de pijnklachten en beperkingen ernstig zijn.

Doel

Wij denken voor deze complexere patiëntengroep de behandeling te kunnen verbeteren, door het gebruik van therapeutische virtual reality (VR).

Werkwijze

Om dit te onderzoeken voeren we een gerandomiseerd gecontroleerde studie uit bij 120 mensen. Dit zijn mensen met chronische lage rugpijn die vanwege hun rugklachten een fysiotherapeut bezoeken en waarbij sprake is van ernstige klachten en beperkingen. De ene helft ontvangt de nieuwe fysiotherapiebehandeling met VR, de andere helft ontvangt de gebruikelijke fysiotherapiebehandeling. Wij zullen bij de deelnemers vragenlijsten afnemen bij aanvang en na 3 en 12 maanden, waarmee de effectiviteit en kosteneffectiviteit van beide behandelingen vergeleken worden. Onze belangrijkste uitkomstmaat is de mate van beperkingen in dagelijkse activiteiten (ODI vragenlijst).

Interview

Lees hoe 2 innovaties voor betere behandeling van chronische lage rugpijn, deze oefeningen met Virtual Reality en een digitaal keuzehulpmiddel, elkaar kunnen versterken en leiden tot meer doelmatigheid.

> Interview met Karin Verkerk en Jesper Knoop

 

Afbeelding
Jesper Knoop en Karin Verkerk

Producten

Titel: Physiotherapy with integrated virtual reality for patients with complex chronic low back pain: protocol for a pragmatic cluster randomized controlled trial (VARIETY study)
Auteur: Syl Slatman, Raymond Ostelo, Harry van Goor J Bart Staal, Jesper Knoop
Magazine: BMC Musculoskeletal Disorders
Begin- en eindpagina:
Link: https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-023-06232-0

Verslagen


Samenvatting van de aanvraag

OBJECTIVE Our primary objective is to investigate whether a personalised, physiotherapy intervention with integrated therapeutic virtual reality (VR) is (cost-)effective at 3 months and 12 months follow-up, compared to usual physiotherapy, in a subgroup of patients with complex chronic low back pain (LBP) and severe disability and pain. This VR-integrated intervention, personalised to specific patient characteristics and preferences, will first be refined through a co-creation process, and then pre-tested in a pilot and feasibility study, and further optimised. Second, we will test the (cost-)effectiveness of our intervention compared to usual care in a cluster randomised controlled trial, and explore underlying (pain, adherence and behaviour-related) working mechanisms. Third, if proven (cost-)effective in this trial, we will implement our intervention among physiotherapists and patients, taking into account barriers and facilitators for implementation, which we will identify during the pilot and feasibility study and the trial. DESIGN Cluster randomized controlled trial POPULATION 120 chronic LBP patients with a combination of severe disability and severe pain, consulting a physiotherapist in primary care. OUTCOMES Physical functioning (primary outcome), in addition to pain and a minimal set of other secondary clinical, adherence-related, psychological and economic measures, at baseline and 1, 3 and 12 months follow-up. RELEVANCE Physiotherapy, mainly consisting of exercise therapy and patient education, is a first-choice primary care treatment for patients with chronic LBP. Unfortunately, especially patients with severe disability and pain demonstrate poor outcomes. The severity of their symptoms and associated pain-related fears hinder them from exercising. Moreover, physiotherapists often struggle to provide this complex subgroup an effective treatment, especially when a cognitive-behaviour-oriented approach of exercise therapy and patient education is needed because of the presence of pain-related fears. Furthermore, this complex subgroup tends to have a low level of adherence, and are more likely to drop out of treatment. This complex subgroup is also associated with more visits to expensive, but mostly ineffective secondary care and with increased sick leave, which lead to a substantial societal and economic burden. Therapeutic VR is considered a potential breakthrough for LBP patients in general and for our complex group of patients with severe disability and pain in particular, as it specifically targets the identified limitations of usual physiotherapy. VR is particularly promising for our complex subgroup, if personalised to relevant patient factors, needs and preferences and if integrated adequately within physiotherapy treatment. More specifically, our VR-integrated physiotherapy treatment is expected to facilitate patients with severe symptoms to start exercising through distraction and short-term pain relief (pain-related mechanisms), to keep them motivated to continue their exercises and physical activities (adherence-related mechanisms) and to help physiotherapists apply a cognitive-behaviour-oriented approach to exercise therapy and patient education (behaviour-related mechanisms). Therefore, a personalised, VR-integrated physiotherapy intervention, tailored to specific patient characteristics, is expected to result in larger improvements in physical functioning and pain, and more favourable cost-effectiveness, compared to usual physiotherapy. SCHEDULE Month 1-12: co-creation process, pilot and feasibility study; Month 13-36: RCT with qualitative evaluation; Month 37-48: implementation. KEYWORDS Chronic low back pain; complex patients; virtual reality, personalised care; patient characteristics; pain; adherence; psychological factors; mechanisms; randomised controlled trial

Kenmerken

Projectnummer:
10270032021502
Looptijd: 62%
Looptijd: 62 %
2021
2025
Onderdeel van programma:
Gerelateerde subsidieronde:
Projectleider en penvoerder:
dr. J. Knoop
Verantwoordelijke organisatie:
HAN University of Applied Sciences
Afbeelding

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