Cargando…

Feasibility of a multidisciplinary group videoconferencing approach for chronic low back pain: a randomized, open-label, controlled, pilot clinical trial (EN-FORMA)

BACKGROUND: Low back pain is a common condition that becomes even more prevalent with aging. A non-pharmacological multidisciplinary approach for chronic non-specific low back pain (CNSLBP) has been recommended, but integrating different healthcare professionals is challenging. A multidisciplinary g...

Descripción completa

Detalles Bibliográficos
Autores principales: Garreta-Catala, Iago, Planas-Balagué, Rosa, Abouzari, Reza, Carnaval, Thiago, Nolla, Joan M., Videla, Sebastián, Agulló-Ferré, José-Luis
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10410913/
https://www.ncbi.nlm.nih.gov/pubmed/37558990
http://dx.doi.org/10.1186/s12891-023-06763-6
_version_ 1785086557578854400
author Garreta-Catala, Iago
Planas-Balagué, Rosa
Abouzari, Reza
Carnaval, Thiago
Nolla, Joan M.
Videla, Sebastián
Agulló-Ferré, José-Luis
author_facet Garreta-Catala, Iago
Planas-Balagué, Rosa
Abouzari, Reza
Carnaval, Thiago
Nolla, Joan M.
Videla, Sebastián
Agulló-Ferré, José-Luis
author_sort Garreta-Catala, Iago
collection PubMed
description BACKGROUND: Low back pain is a common condition that becomes even more prevalent with aging. A non-pharmacological multidisciplinary approach for chronic non-specific low back pain (CNSLBP) has been recommended, but integrating different healthcare professionals is challenging. A multidisciplinary group videoconferencing approach (MGVA) can be helpful. Our aim was to provide evidence on MGVA's feasibility in managing CNSLBP and its impact on clinical practice. METHODS: We conducted an open-label, randomized, controlled, parallel-group pilot clinical trial with CNSLBP patients irresponsive to conservative treatment. Patients between 18 and 67 years of age were randomly assigned (1:1) to either Standard-of-Care + MGVA (experimental group) or Standard-of-Care alone (control group). MGVA consisted of integrated sessions for physical rehabilitation/physiotherapy, psychology, and social work treatments. The control group received standard clinical practice treatment. The feasibility was assessed by the number of study procedures completed to at least 80% as planned. The impact on clinical practice was evaluated by the number of patients who changed their status from "candidate" to "non-candidate" to low back surgery as the treatment of choice for CNSLBP. The SF–36, Oswestry Disability Index, and TMMS–24 questionnaires were used. We performed a whole population-based descriptive analysis. RESULTS: We included 20 patients, but only 18 were randomized (2 withdrew consent before randomization). The mean (SD) age was 53.1 (5.9) years, and mostly women (13/18); 7 were actively employed. In the experimental group, 6/9 (67%, 95%CI:35–88%) patients attended at least 80% of the scheduled procedures, while in the control group, 8/9 (89%, 95%CI:57–98%) did. Additionally, 1 out of 4 (25%) patients in the experimental group changed their status from "candidate" for low back surgery to "non-candidate". None of the 2 patients in the control group did so. We found differences between groups in the SF-36 mental health component (p-value:0.061), Oswestry Disability Index (p-value:0.032), and TMMS-24 Repair component (p-value:0.014) at the end of the trial favoring MGVA. CONCLUSIONS: The multidisciplinary group videoconferencing approach to managing chronic non-specific low back pain was feasible, suggesting overall beneficial effects on patients’ health and could play a role in changing a patient's status from “candidate” to “non-candidate” for surgery. TRIAL REGISTRATION: NCT05093543 (ClinicalTrials.gov), first registered in 26/10/2021. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12891-023-06763-6.
format Online
Article
Text
id pubmed-10410913
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-104109132023-08-10 Feasibility of a multidisciplinary group videoconferencing approach for chronic low back pain: a randomized, open-label, controlled, pilot clinical trial (EN-FORMA) Garreta-Catala, Iago Planas-Balagué, Rosa Abouzari, Reza Carnaval, Thiago Nolla, Joan M. Videla, Sebastián Agulló-Ferré, José-Luis BMC Musculoskelet Disord Research BACKGROUND: Low back pain is a common condition that becomes even more prevalent with aging. A non-pharmacological multidisciplinary approach for chronic non-specific low back pain (CNSLBP) has been recommended, but integrating different healthcare professionals is challenging. A multidisciplinary group videoconferencing approach (MGVA) can be helpful. Our aim was to provide evidence on MGVA's feasibility in managing CNSLBP and its impact on clinical practice. METHODS: We conducted an open-label, randomized, controlled, parallel-group pilot clinical trial with CNSLBP patients irresponsive to conservative treatment. Patients between 18 and 67 years of age were randomly assigned (1:1) to either Standard-of-Care + MGVA (experimental group) or Standard-of-Care alone (control group). MGVA consisted of integrated sessions for physical rehabilitation/physiotherapy, psychology, and social work treatments. The control group received standard clinical practice treatment. The feasibility was assessed by the number of study procedures completed to at least 80% as planned. The impact on clinical practice was evaluated by the number of patients who changed their status from "candidate" to "non-candidate" to low back surgery as the treatment of choice for CNSLBP. The SF–36, Oswestry Disability Index, and TMMS–24 questionnaires were used. We performed a whole population-based descriptive analysis. RESULTS: We included 20 patients, but only 18 were randomized (2 withdrew consent before randomization). The mean (SD) age was 53.1 (5.9) years, and mostly women (13/18); 7 were actively employed. In the experimental group, 6/9 (67%, 95%CI:35–88%) patients attended at least 80% of the scheduled procedures, while in the control group, 8/9 (89%, 95%CI:57–98%) did. Additionally, 1 out of 4 (25%) patients in the experimental group changed their status from "candidate" for low back surgery to "non-candidate". None of the 2 patients in the control group did so. We found differences between groups in the SF-36 mental health component (p-value:0.061), Oswestry Disability Index (p-value:0.032), and TMMS-24 Repair component (p-value:0.014) at the end of the trial favoring MGVA. CONCLUSIONS: The multidisciplinary group videoconferencing approach to managing chronic non-specific low back pain was feasible, suggesting overall beneficial effects on patients’ health and could play a role in changing a patient's status from “candidate” to “non-candidate” for surgery. TRIAL REGISTRATION: NCT05093543 (ClinicalTrials.gov), first registered in 26/10/2021. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12891-023-06763-6. BioMed Central 2023-08-09 /pmc/articles/PMC10410913/ /pubmed/37558990 http://dx.doi.org/10.1186/s12891-023-06763-6 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Garreta-Catala, Iago
Planas-Balagué, Rosa
Abouzari, Reza
Carnaval, Thiago
Nolla, Joan M.
Videla, Sebastián
Agulló-Ferré, José-Luis
Feasibility of a multidisciplinary group videoconferencing approach for chronic low back pain: a randomized, open-label, controlled, pilot clinical trial (EN-FORMA)
title Feasibility of a multidisciplinary group videoconferencing approach for chronic low back pain: a randomized, open-label, controlled, pilot clinical trial (EN-FORMA)
title_full Feasibility of a multidisciplinary group videoconferencing approach for chronic low back pain: a randomized, open-label, controlled, pilot clinical trial (EN-FORMA)
title_fullStr Feasibility of a multidisciplinary group videoconferencing approach for chronic low back pain: a randomized, open-label, controlled, pilot clinical trial (EN-FORMA)
title_full_unstemmed Feasibility of a multidisciplinary group videoconferencing approach for chronic low back pain: a randomized, open-label, controlled, pilot clinical trial (EN-FORMA)
title_short Feasibility of a multidisciplinary group videoconferencing approach for chronic low back pain: a randomized, open-label, controlled, pilot clinical trial (EN-FORMA)
title_sort feasibility of a multidisciplinary group videoconferencing approach for chronic low back pain: a randomized, open-label, controlled, pilot clinical trial (en-forma)
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10410913/
https://www.ncbi.nlm.nih.gov/pubmed/37558990
http://dx.doi.org/10.1186/s12891-023-06763-6
work_keys_str_mv AT garretacatalaiago feasibilityofamultidisciplinarygroupvideoconferencingapproachforchroniclowbackpainarandomizedopenlabelcontrolledpilotclinicaltrialenforma
AT planasbalaguerosa feasibilityofamultidisciplinarygroupvideoconferencingapproachforchroniclowbackpainarandomizedopenlabelcontrolledpilotclinicaltrialenforma
AT abouzarireza feasibilityofamultidisciplinarygroupvideoconferencingapproachforchroniclowbackpainarandomizedopenlabelcontrolledpilotclinicaltrialenforma
AT carnavalthiago feasibilityofamultidisciplinarygroupvideoconferencingapproachforchroniclowbackpainarandomizedopenlabelcontrolledpilotclinicaltrialenforma
AT nollajoanm feasibilityofamultidisciplinarygroupvideoconferencingapproachforchroniclowbackpainarandomizedopenlabelcontrolledpilotclinicaltrialenforma
AT videlasebastian feasibilityofamultidisciplinarygroupvideoconferencingapproachforchroniclowbackpainarandomizedopenlabelcontrolledpilotclinicaltrialenforma
AT agulloferrejoseluis feasibilityofamultidisciplinarygroupvideoconferencingapproachforchroniclowbackpainarandomizedopenlabelcontrolledpilotclinicaltrialenforma
AT feasibilityofamultidisciplinarygroupvideoconferencingapproachforchroniclowbackpainarandomizedopenlabelcontrolledpilotclinicaltrialenforma