RESUMO
BACKGROUND: Core stability exercise (CSE) is a globally acknowledged intervention for managing chronic low back pain. However, the sustained adherence of patients with chronic low back pain to CSE can be challenging, mainly due to the absence of supervision and guidance from physical therapists during home-based exercise sessions. Consequently, exercise compliance tends to decline, resulting in suboptimal long-term effectiveness of the intervention. In this trial, our primary aim is to evaluate the potential therapeutic equivalence between home-based rehabilitation training employing key point identification technology and exercise guidance administered in a hospital setting. METHODS: In this trial, we will randomly assign 104 adults with chronic low back pain (CLBP) to either an intervention or control group, with 52 participants in each group. Both interventions will consist of three weekly 0.5-h sessions of core stability exercise (CSE). The intervention group will engage in home rehabilitation training utilizing key identification technology for movement, while the control group will perform supervised exercises in a hospital setting. Outcome assessments will be conducted at 4 weeks and 16 weeks after randomization. The primary outcome measure will be the change in pain intensity based on numeric rating scale (NRS scores) from baseline to 4 weeks. Secondary outcomes will include changes in physical function (measured by the Oswestry Disability Index (ODI)) and lumbar spine mobility as well as activity participation and treatment satisfaction. DISCUSSION: If home-based rehabilitation method is demonstrated to be non-inferior or even superior to traditional face-to-face exercise guidance, it could significantly advance the adoption of digital medical care and contribute to improving the overall health of the population. TRIAL REGISTRATION: NCT05998434 . Registered on 16 August 2023.
Assuntos
Dor Crônica , Dor Lombar , Adulto , Humanos , Dor Lombar/diagnóstico , Dor Lombar/terapia , Resultado do Tratamento , Terapia por Exercício/métodos , Avaliação de Resultados em Cuidados de Saúde , Vértebras Lombares , Dor Crônica/diagnóstico , Dor Crônica/terapia , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
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.