Feasibility of a multidisciplinary group videoconferencing approach for chronic low back pain: a randomized, open-label, controlled, pilot clinical trial (EN-FORMA)
Authors: Garreta-Catala Iago , Planas-Balagué Rosa , Abouzari Reza , Carnaval Thiago , Nolla Joan M. , Videla Sebastián , Agulló-Ferré José-Luis ,   the EN-FORMA study group, Calvis-Garcia Paula , Carmezim João , Company-Llimona Anna , Fernandez-Mariscal Esmeralda , Fernandez-Solana Coral , Figuerola-Batista Montserrat , Gerique-Fornas Neus , Grifell-Martín Encarna , Gutierrez-Jimenez Nuria , Mariano-Martin Nuria , Mas-Garriga Xavier , Otero-Gonzalez Aurema , Soler-Soto Sandra , Tebé Cristian , Vázquez-Ventura Teresa , Vázquez-Vera Carlota , Vicent-Porquet Ramón 
Published: August 2023

Abstract
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.