Outcomes
Anxiety, Pain, Oswestry Disability, Chronic pain, Low back pain disability, Depression
The primary endpoints were clinical trial feasibility and its impact on clinical practice. The clinical trial feasibility was assessed by the number of study procedures completed to at least 80% as planned. In the experimental group, we assessed (i) the number (percentage) of scheduled visits attended by the included patients; (ii) the number (percentage) of questionnaires fulfilled by the included patients; (iii) the number (percentage) of scheduled MGVA sessions attended by the included patients; and (iv) the number (percentage) of MGVA sessions performed as planned was also assessed (sessions were considered satisfactory when performed coordinately by the three therapists, when no internet connection issues occurred, when they started and finished on the expected time and date, and when patients had a proactive role). In the control group, we assessed (i) the number (percentage) of scheduled visits attended by the patients; and (ii) the number (percentage) of questionnaires fulfilled by them.The impact on clinical practice was evaluated by the number of patients who changed their status from “candidate” to “non-candidate”/ “non-candidate” to “candidate” for low back surgery as the treatment of choice for CNSLBP.Secondary endpoints were:QoL evaluated by the SF-36 questionnaire [Low back pain disability estimated by the Oswestry Disability Index (ODI) score [Physical Activity assessed by the International Physical Activity Questionnaire – Short Form (IPAQ-SF) score [Anxiety and Depression evaluated by the Hospital Anxiety-Depression Scale (HADS) score [Chronic pain coping strategies assessed by the Vanderbilt Pain Management Inventory (VPMI) score [Awareness and emotional self-regulation evaluated by the Trait Meta-Mood Scale (TMMS-24) score [Mental wellbeing evaluated by the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) score [Level of social support estimated by the Oslo-3 questionnaire score [We used the Spanish version of all the above-mentioned scales and questionnaires. All randomized patients received the questionnaires by email at the beginning and 6 months after the study start. The SF-36 questionnaire was also sent after concluding the last MGVA session (two months after the beginning of the study). All answers were automatically inserted in the eCRF.