Effect of m-health-based core stability exercise combined with self-compassion training for patients with non-specific chronic low back pain: study protocol for a randomized controlled trial

BACKGROUND: Non-specific chronic low back pain (NCLBP) has a high incidence, which has a significant impact on a patient’s body and mind and is a common condition affecting people’s quality of life. Core stability exercise (CSE) is a modestly effective treatment for NCLBP; however, CSE has only been shown to be a useful treatment option in the short term. Many clinical practice guidelines recommend the use of a biopsychosocial framework to guide the management of NCLBP. Self-compassion training (SCT) is a promising psychotherapy treatment option for NCLBP; however, there is still a lack of research on CSE combined with SCT. In this study, we will seek to determine whether CSE combined with SCT is an effective treatment option for patients with NCLBP compared to CSE alone. METHODS: In this study, we will randomize 166 adults with NCLBP to a combined SCT and CSE arm or a CSE alone arm (83 participants per group). Both interventions will consist of four weekly 1.5-h group sessions of CSE supplemented by home practice. The combined group protocol also includes 2 h of SCT before CSE. Interviewers masked to the treatment assignments will assess the outcomes at 4 and 16 weeks post-randomization. The primary outcomes are back pain disability (based on the Roland-Morris Disability Questionnaire) and pain intensity (NRS; average pain, worst pain, average pain) at 16 weeks. DISCUSSION: If SCT is found to enhance the effectiveness of CSE for patients with chronic back pain, the results of the study may promote the development of mind-body therapies for chronic low back pain. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100042810. Registered on 21 January 2021