The Effectiveness and Safety of Utilizing Mobile Phone–Based Programs for Rehabilitation After Lumbar Spinal Surgery: Multicenter, Prospective Randomized Controlled Trial (Preprint)

Abstract

Background:Rehabilitation is very important for postoperative patients with low back pain. However, the promotion of traditional clinic-based program is limited in developing countries like China, due to the maldistribution of medical resources. Smartphones may be a potential substitute for those who have no access to traditional rehabilitation. Objective:The aim of this study was to examine the efficacy of a smartphone based rehabilitation system in patients accepted lumbar spinal operation. Methods:Postoperative patients with low back pain were recruited and randomized to rehabilitation treatment provide by smartphone based e-health program (EH) or usual care treatment (UC) as control group. Primary outcomes were function and pain status assessed by Oswestry Disability Index (ODI) and visual analogue scale (VAS). Secondary outcomes were general mental health and life status (Likert scales, EQ-5D and SF-36). All the patients were assessed pre-operatively and then at 3, 6, 12 and 24 months post-operatively. ResultsA total of 168 of the 863 eligible patients were included and randomized in this study. The analysis showed that the improvement in EH group was superior to UC group at 24 months postoperatively (mean difference: ODI 7.02, SD 3.1, P<0.05; VAS 7.59, SD 3.42, P<0.05). No significant difference of primary outcomes was found at the other time points. Subgroup analysis showed that the improvements of the primary outcomes were more significant in those considered as high compliance in the EH group throughout the trial, compared with the UC group at 6, 12 and 24 months. Conclusion:This research demonstrated that E-health, a smart phone based tele-rehabilitation system can be an effective rehabilitation tool in self-management for postoperative patient with low back pain.The effectiveness of E-health was more evident in high adherent participants. Still, more researches are needed to understand factors associated with patients' adherence.Trial Registration: Chinese clinical trial registry, ChiCTR-TRC-13003314,