The Effect of M-Health-Based Core Stability Exercise Combined with Self-Compassion Training for Patients with Nonspecific Chronic Low Back Pain: A Randomized Controlled Pilot Study.

introductionNonspecific chronic low back pain (NCLBP) is a leading contributor to disease burden worldwide, and the management of NCLBP has always been a problem. This study is designed to explore the feasibility and efficacy of m-health-based core stability exercise (CSE) combined with self-compassion training (SCT) and compare it with m-health-based CSE alone for the management of NCLBP.

methodsThis study is a pilot, patient-blinded randomized controlled trial. Participants with NCLBP were randomized into an intervention group and a control group. All the participants received m-health-based CSE, but those in the intervention group also received SCT before CSE. The intervention took place weekly on Saturday or Sunday for 4 weeks in total. Patients self-assessed their outcomes by filling out electronic questionnaires at 4 and 16 weeks after the start of the study. The primary outcome metrics for these questionnaires were back pain disability (based on the Roland-Morris Disability Questionnaire, RMDQ) and Pain intensity (Numeric Rating Scale, NRS; current pain, worst pain, average pain). The secondary outcome metrics were anxiety (GAD-7,7-item Generalized Anxiety Disorder scale), Depression Symptoms (PHQ-9,Patient Health Questionnaire-9), pain catastrophizing (PCS, Pain Catastrophizing Scale) and Self-efficiency (PSEQ, Pain Self-Efficiency Questionnaire).

resultsA total of 37 patients comprising 28 (75.7%) females completed the study, with 19 patients in the intervention group and 18 in the control group. The mean (SD) patient age was 35.2 (11.1) years. For all primary outcomes, although there were no significant differences between groups, we found that participants in the intervention group improved function and pain earlier. The RMDQ score changed by - 1.771 points (95% CI - 3.768 to 0.227) from baseline to 4 weeks in the control group and by - 4.822 points (95% CI - 6.752 to - 2.892) in the intervention group (difference between groups, - 3.052 [95% CI - 5.836 to - 0.267]). Also, the RMDQ score changed by - 3.328 points (95% CI - 5.252 to - 1.403) from baseline to 16 weeks in the control group and by - 5.124 points (95% CI - 7.014 to - 3.233) in the intervention group (difference between groups - 1.796 [95% CI - 4.501 to 0.909]). A similar pattern was found in the NRS scores. For secondary outcomes, the intervention group was superior to the control group in for GAD-7 (intervention difference from CSE along at week 16, - 2.156 [95% CI - 4.434 to - 0.122; P value for group effect was 0.030]). At the end of treatment, the improvement in PCS in the intervention group was significant (difference in PCS score at week 4, - 6.718 [95% CI - 11.872 to - 1.564]). We also found significant changes in PCS in the control group (- 6.326 [95% CI, - 11.250 to - 1.401]) at the 16-week follow-up. As for PSEQ, there were no apparent differences between the two groups. There were no adverse events relented to study participation.

conclusionsThe pilot study is feasible to deliver, and our results indicate that participants in the group of m-health-based CSE combined with SCT may experience faster relief from pain intensity and back disability than those in the group of m-health-based CSE alone.

trial registrationChiCTR2100042810.