Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study)
Introduction: The On&Out study is aimed at assessing the effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent intervention conducted in two different settings: online (FIBRO-On) or outdoors (FIBRO-Out). Both interventions have proved to be efficacious i...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-11-01
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| Series: | Frontiers in Physiology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphys.2022.1046613/full |
| _version_ | 1797989044240515072 |
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| author | Mayte Serrat Mayte Serrat Sònia Ferrés Sònia Ferrés William Auer Míriam Almirall Enrique Lluch Enrique Lluch Enrique Lluch Francesco D’Amico Michael Maes Sonia Lorente Sonia Lorente Jaime Navarrete Jaime Navarrete Jesús Montero-Marín Jesús Montero-Marín Randy Neblett Jo Nijs Jo Nijs Jo Nijs Xavier Borràs Xavier Borràs Juan V. Luciano Juan V. Luciano Albert Feliu-Soler Albert Feliu-Soler |
| author_facet | Mayte Serrat Mayte Serrat Sònia Ferrés Sònia Ferrés William Auer Míriam Almirall Enrique Lluch Enrique Lluch Enrique Lluch Francesco D’Amico Michael Maes Sonia Lorente Sonia Lorente Jaime Navarrete Jaime Navarrete Jesús Montero-Marín Jesús Montero-Marín Randy Neblett Jo Nijs Jo Nijs Jo Nijs Xavier Borràs Xavier Borràs Juan V. Luciano Juan V. Luciano Albert Feliu-Soler Albert Feliu-Soler |
| author_sort | Mayte Serrat |
| collection | DOAJ |
| description | Introduction: The On&Out study is aimed at assessing the effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent intervention conducted in two different settings: online (FIBRO-On) or outdoors (FIBRO-Out). Both interventions have proved to be efficacious in the short-term but there is no study assessing their comparative effectiveness nor their long-term effects. For the first time, this study will also evaluate the cost-utility (6-month time-horizon) and the effects on immune-inflammatory biomarkers and Brain-Derived Neurotrophic Factor (BDNF) levels of both interventions. The objectives of this 6-month, randomized, controlled trial (RCT) are 1) to examine the effectiveness and cost-utility of adding FIBRO-On or FIBRO-Out to Treatment-As-Usual (TAU) for individuals with fibromyalgia (FM); 2) to identify pre–post differences in blood biomarker levels in the three study arms and 3) to analyze the role of process variables as mediators of 6-month follow-up clinical outcomes.Methods and analysis: Participants will be 225 individuals with FM recruited at Vall d’Hebron University Hospital (Barcelona, Spain), randomly allocated to one of the three study arms: TAU vs. TAU + FIBRO-On vs. TAU + FIBRO-Out. A comprehensive assessment to collect functional impairment, pain, fatigue, depressive and anxiety symptoms, perceived stress, central sensitization, physical function, sleep quality, perceived cognitive dysfunction, kinesiophobia, pain catastrophizing, psychological inflexibility in pain and pain knowledge will be conducted pre-intervention, at 6 weeks, post-intervention (12 weeks), and at 6-month follow-up. Changes in immune-inflammatory biomarkers [i.e., IL-6, CXCL8, IL-17A, IL-4, IL-10, and high-sensitivity C-reactive protein (hs-CRP)] and Brain-Derived Neurotrophic Factor will be evaluated in 40 participants in each treatment arm (total n = 120) at pre- and post-treatment. Quality of life and direct and indirect costs will be evaluated at baseline and at 6-month follow-up. Linear mixed-effects regression models using restricted maximum likelihood, mediational models and a full economic evaluation applying bootstrapping techniques, acceptability curves and sensitivity analyses will be computed.Ethics and dissemination: This study has been approved by the Ethics Committee of the Vall d’Hebron Institute of Research. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and various community engagement activities. Trial registration number NCT05377567 (clinicaltrials.gov). |
| first_indexed | 2024-04-11T08:13:59Z |
| format | Article |
| id | doaj.art-adc3f8ecfcd74ce88d060dbdac591882 |
| institution | Directory Open Access Journal |
| issn | 1664-042X |
| language | English |
| last_indexed | 2024-04-11T08:13:59Z |
| publishDate | 2022-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Physiology |
| spelling | doaj.art-adc3f8ecfcd74ce88d060dbdac5918822022-12-22T04:35:14ZengFrontiers Media S.A.Frontiers in Physiology1664-042X2022-11-011310.3389/fphys.2022.10466131046613Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study)Mayte Serrat0Mayte Serrat1Sònia Ferrés2Sònia Ferrés3William Auer4Míriam Almirall5Enrique Lluch6Enrique Lluch7Enrique Lluch8Francesco D’Amico9Michael Maes10Sonia Lorente11Sonia Lorente12Jaime Navarrete13Jaime Navarrete14Jesús Montero-Marín15Jesús Montero-Marín16Randy Neblett17Jo Nijs18Jo Nijs19Jo Nijs20Xavier Borràs21Xavier Borràs22Juan V. Luciano23Juan V. Luciano24Albert Feliu-Soler25Albert Feliu-Soler26Unitat d’Expertesa en Síndromes de Sensibilització Central, Servei de Reumatologia, Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Barcelona, SpainEscoles Universitàries Gimbernat, Autonomous University of Barcelona, Barcelona, SpainEscoles Universitàries Gimbernat, Autonomous University of Barcelona, Barcelona, SpainDepartment of Basic, Developmental and Educational Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, SpainDepartment of Basic, Developmental and Educational Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, SpainUnitat d’Expertesa en Síndromes de Sensibilització Central, Servei de Reumatologia, Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Barcelona, SpainDepartment of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Valencia, SpainPhysiotherapy in Motion, Multi-Specialty Research Group (PTinMOTION), Department of Physiotherapy, University of Valencia, Valencia, SpainPain in Motion International Research Group, Brussels, BelgiumCare Policy and Evaluation Centre (CPEC), London School of Economics and Political Science (LSE), London, United KingdomDepartment of Psychiatry, Faculty of Medicine, Chulalongkorn University, Bangkok, ThailandDepartment of Psychobiology and Methodology of Health Science, Autonomous University of Barcelona, Barcelona, Spain0Pediatric Area, PNP, Hospital de Terrassa, Consorci Sanitari de Terrassa, Terrassa, SpainDepartment of Basic, Developmental and Educational Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, Spain1Psychological Research in Fibromyalgia and Chronic Pain (AGORA Research Group), Parc Sanitari Sant Joan de Déu, Barcelona, Spain1Psychological Research in Fibromyalgia and Chronic Pain (AGORA Research Group), Parc Sanitari Sant Joan de Déu, Barcelona, Spain2Warneford Hospital, Department of Psychiatry, University of Oxford, Oxford, United Kingdom3PRIDE Research Foundation, Dallas, TX, United StatesPain in Motion International Research Group, Brussels, Belgium4Pain in Motion Research Group (PAIN), Department of Physiotherapy, Human Physiology, and Anatomy, Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium5Department of Health and Rehabilitation, Unit of Physiotherapy, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenDepartment of Basic, Developmental and Educational Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, Spain1Psychological Research in Fibromyalgia and Chronic Pain (AGORA Research Group), Parc Sanitari Sant Joan de Déu, Barcelona, Spain1Psychological Research in Fibromyalgia and Chronic Pain (AGORA Research Group), Parc Sanitari Sant Joan de Déu, Barcelona, Spain7Department of Clinical and Health Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, Spain1Psychological Research in Fibromyalgia and Chronic Pain (AGORA Research Group), Parc Sanitari Sant Joan de Déu, Barcelona, Spain7Department of Clinical and Health Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, SpainIntroduction: The On&Out study is aimed at assessing the effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent intervention conducted in two different settings: online (FIBRO-On) or outdoors (FIBRO-Out). Both interventions have proved to be efficacious in the short-term but there is no study assessing their comparative effectiveness nor their long-term effects. For the first time, this study will also evaluate the cost-utility (6-month time-horizon) and the effects on immune-inflammatory biomarkers and Brain-Derived Neurotrophic Factor (BDNF) levels of both interventions. The objectives of this 6-month, randomized, controlled trial (RCT) are 1) to examine the effectiveness and cost-utility of adding FIBRO-On or FIBRO-Out to Treatment-As-Usual (TAU) for individuals with fibromyalgia (FM); 2) to identify pre–post differences in blood biomarker levels in the three study arms and 3) to analyze the role of process variables as mediators of 6-month follow-up clinical outcomes.Methods and analysis: Participants will be 225 individuals with FM recruited at Vall d’Hebron University Hospital (Barcelona, Spain), randomly allocated to one of the three study arms: TAU vs. TAU + FIBRO-On vs. TAU + FIBRO-Out. A comprehensive assessment to collect functional impairment, pain, fatigue, depressive and anxiety symptoms, perceived stress, central sensitization, physical function, sleep quality, perceived cognitive dysfunction, kinesiophobia, pain catastrophizing, psychological inflexibility in pain and pain knowledge will be conducted pre-intervention, at 6 weeks, post-intervention (12 weeks), and at 6-month follow-up. Changes in immune-inflammatory biomarkers [i.e., IL-6, CXCL8, IL-17A, IL-4, IL-10, and high-sensitivity C-reactive protein (hs-CRP)] and Brain-Derived Neurotrophic Factor will be evaluated in 40 participants in each treatment arm (total n = 120) at pre- and post-treatment. Quality of life and direct and indirect costs will be evaluated at baseline and at 6-month follow-up. Linear mixed-effects regression models using restricted maximum likelihood, mediational models and a full economic evaluation applying bootstrapping techniques, acceptability curves and sensitivity analyses will be computed.Ethics and dissemination: This study has been approved by the Ethics Committee of the Vall d’Hebron Institute of Research. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and various community engagement activities. Trial registration number NCT05377567 (clinicaltrials.gov).https://www.frontiersin.org/articles/10.3389/fphys.2022.1046613/fullfibromyalgiaonlineoutdoorpain neuroscience educationeffectivenesscost-utility |
| spellingShingle | Mayte Serrat Mayte Serrat Sònia Ferrés Sònia Ferrés William Auer Míriam Almirall Enrique Lluch Enrique Lluch Enrique Lluch Francesco D’Amico Michael Maes Sonia Lorente Sonia Lorente Jaime Navarrete Jaime Navarrete Jesús Montero-Marín Jesús Montero-Marín Randy Neblett Jo Nijs Jo Nijs Jo Nijs Xavier Borràs Xavier Borràs Juan V. Luciano Juan V. Luciano Albert Feliu-Soler Albert Feliu-Soler Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study) Frontiers in Physiology fibromyalgia online outdoor pain neuroscience education effectiveness cost-utility |
| title | Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study) |
| title_full | Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study) |
| title_fullStr | Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study) |
| title_full_unstemmed | Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study) |
| title_short | Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study) |
| title_sort | effectiveness cost utility and physiological underpinnings of the fibrowalk multicomponent therapy in online and outdoor format in individuals with fibromyalgia study protocol of a randomized controlled trial on out study |
| topic | fibromyalgia online outdoor pain neuroscience education effectiveness cost-utility |
| url | https://www.frontiersin.org/articles/10.3389/fphys.2022.1046613/full |
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