Study protocol randomised controlled trial comparison of cost-utility and cost-effectiveness of a face-to-face rehabilitation programme versus a telemedicine programme in the treatment of patients with chronic low back pain

Adelaida M Castro-Sanchez, Guillermo Adolfo Matarán-Peñarrocha, Silvia Gómez-García, Héctor García-López, Lazaro Andronis, Manuel Albornoz-Cabello, Inmaculada C Lara Palomo, Adelaida M Castro-Sanchez, Guillermo Adolfo Matarán-Peñarrocha, Silvia Gómez-García, Héctor García-López, Lazaro Andronis, Manuel Albornoz-Cabello, Inmaculada C Lara Palomo

Abstract

Introduction: Chronic lower back pain is a highly prevalent medical condition in Western countries, which that incurs a considerable social and economic burden. Although prescription exercise at home for chronic pain has become a widely used alternative to reduce healthcare costs, the evidence regarding patient adherence and decreased in costs in European countries is scarce and inconclusive. The objective of this study is to examine the cost-utility and cost-effectiveness in patients with chronic lower back pain treated with the McKenzie Method and electroanalgesia via a telemedicine programme versus a face-to-face programme.

Methods and analysis: This study reports the protocol for a randomised, two-arm, multicentre, parallel controlled trial. A total of 540 patients with chronic lower back pain (onset time ≥3 months, Roland Morris Disability Questionnaire ≥4) will be recruited in three hospitals in Andalusia. Participants will be assigned to one of two groups (n=270, respectively) to receive electroanalgesia and Mckenzie method exercises through a telemedicine or a face-to-face programme. A total of 24 sessions will be administered three times a week for 8 weeks. Since the study design does not allow participant blinding, the outcome assessor and the statistician will be blinded. Use of helth care resources and costs due to work absenteeism will be captured and analysed. In addition, pain, intensity, fear of movement, quality of life and strength of the core muscle and anteflexion lumbar will be recorded at 2 and 6 months after the start of treatment.

Ethics and dissemination: Human Research and Local Ethics Committee of the 'Hospital Complex Torrecárdenas of Almeria, University Hospital of Granada and Virgen Macarena de Sevilla Hospital-Andalusian Health Service'. Study findings will be released to the research, clinical and health service through publication in international journals and conferences.

Trial registration number: NCT04266366.

Keywords: health economics; musculoskeletal disorders; pain management; protocols & guidelines; rehabilitation medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Design and flow of participants through the trial. ODI, Oswestry Disability Index; PHCC, Primary Healthcare Centres; QALYs, quality-adjusted life year; RMQ, Roland-Morris Questionnaire; SF-36, Short-Form Health Survey 36; TSK, Tampa Scale of Kinesiophobia; VAS, Visual Analogue Scale.
Figure 2
Figure 2
Time points of each assessment index. EQ-5D, EuroQol 5 dimensions; ODI, Oswestry Disability Index; RMDQ, Roland-Morris Disability Questionnaire; SF-36, Short-Form Health Survey 36; TSK, Tampa Scale of Kinesiophobia; VAS, Visual Analogue Scale.

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