Zheng Fuming, Zheng Yiyi, Liu Shufeng, Yang Jiajia, Xiao Weihui, Xiao Wenwu, Chen Lichang, Yang Wanting, Zhang Shanshan, Yu Qiuhua, Hao Zengming, Wang Yuyin, Wang Chuhuai
Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, 510080, China.
Department of Psychology, Sun Yat-Sen University, Guangzhou, 510006, China.
Pain Ther. 2022 Jun;11(2):511-528. doi: 10.1007/s40122-022-00358-0. Epub 2022 Feb 8.
INTRODUCTION: Nonspecific 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. METHODS: This 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). RESULTS: A 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. CONCLUSIONS: The 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 REGISTRATION: ChiCTR2100042810.
引言:非特异性慢性下腰痛(NCLBP)是全球疾病负担的主要成因,NCLBP的管理一直是个难题。本研究旨在探讨基于移动健康的核心稳定性训练(CSE)联合自我同情训练(SCT)的可行性和有效性,并将其与单纯基于移动健康的CSE用于NCLBP管理的效果进行比较。 方法:本研究是一项试点、患者盲法随机对照试验。NCLBP患者被随机分为干预组和对照组。所有参与者均接受基于移动健康的CSE,但干预组的参与者在CSE前还接受了SCT。干预每周在周六或周日进行一次,共持续4周。患者在研究开始后的第4周和第16周通过填写电子问卷进行自我评估。这些问卷的主要结局指标是背痛残疾程度(基于罗兰·莫里斯残疾问卷,RMDQ)和疼痛强度(数字评定量表,NRS;当前疼痛、最痛、平均疼痛)。次要结局指标是焦虑(GAD-7,7项广泛性焦虑障碍量表)、抑郁症状(PHQ-9,患者健康问卷-9)、疼痛灾难化(PCS,疼痛灾难化量表)和自我效能感(PSEQ,疼痛自我效能问卷)。 结果:共有37例患者完成研究,其中女性28例(75.7%),干预组19例,对照组18例。患者平均年龄为35.2(11.1)岁。对于所有主要结局,尽管两组之间无显著差异,但我们发现干预组的参与者功能改善和疼痛缓解更早。对照组从基线到第4周RMDQ评分变化了-1.771分(95%CI -3.768至0.227),干预组变化了-4.822分(95%CI -6.752至-2.892)(组间差异为-3.052 [95%CI -5.836至-0.267])。同样,对照组从基线到第16周RMDQ评分变化了-3.328分(95%CI -5.252至-1.403),干预组变化了-5.124分(95%CI -7.014至-3.233)(组间差异为-1.796 [95%CI -4.501至0.909])。NRS评分也呈现类似模式。对于次要结局,干预组在GAD-7方面优于对照组(第16周时CSE联合SCT组与CSE组的干预差异为-2.156 [95%CI -4.434至-0.122];组效应P值为0.030)。治疗结束时,干预组PCS的改善显著(第4周时PCS评分差异为-6.718 [95%CI -11.872至-1.564])。我们还发现对照组在16周随访时PCS也有显著变化(-6.326 [95%CI,-11.250至-1.401])。至于PSEQ,两组之间无明显差异。未发现与研究参与相关的不良事件。 结论:该试点研究实施可行,我们的结果表明,与单纯基于移动健康的CSE组相比,基于移动健康的CSE联合SCT组的参与者疼痛强度和背部残疾缓解可能更快。 试验注册:ChiCTR2100042810
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