Tsiarleston Gavriella, López-Fernández María Dolores, Pavón-Muñoz Rodrigo, Aguilera-García Iván, López-Corchón María, Delgado-Fernández Manuel, Castellote-Caballero María Yolanda, Donoso Belén, Mesa-Ruiz Antonio Manuel, Pozuelo-Calvo Rocío, Ríos-Ortiz Ángela María, Álvarez-Corral Gemma, Marín-Jiménez Nuria, Martinez-Garcia Dario, Chirosa Ríos Ignacio Jesús, Segura-Jiménez Víctor
Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.
UGC Medicina Física y Rehabilitación, Hospital Universitario Virgen de las Nieves, Granada, Spain.
BMJ Open Sport Exerc Med. 2024 Nov 21;10(4):e002188. doi: 10.1136/bmjsem-2024-002188. eCollection 2024.
The HEALTHYBACK trial is based on a multimodal intervention to determine the effectiveness of a supervised physical exercise, mindfulness, behaviour change and pain neuroscience education programme on several health variables in individuals with chronic primary low back pain (CPLBP). The study will be a randomised controlled trial among 70 individuals diagnosed with CPLBP (aged 18-65 years). The intervention will be conducted in person within a hospital setting for 16 weeks and comprises a first phase (16 sessions supervised physical exercise (2 days/week, 45 min/session), mindfulness (1 day/week, 2.5 hours/session), behaviour change (daily/24 hours via a wrist-worn activity prompting device) and pain neuroscience education (1 day/biweekly, 2 hours/session)) and a second phase (16 sessions functional full-body muscle strengthening exercise, 3 days/week, 50 min/session). The primary outcomes will include perceived acute pain, pain pressure threshold, conditioned pain modulation, temporal summation of pain and disability due to pain. Secondary measures will include physical fitness, body composition, gait parameters, device-measured physical activity and sedentary behaviour, haematological profile, self-reported sedentary behaviour, quality of life, pain catastrophising, mental health, sleep duration and quality, and symptoms related to central sensitisation. The groups will undergo pretest (before the intervention), post-test (after each phase of the intervention) and retest (at a 6-week detraining period after the intervention) measurements. The results will determine the effectiveness of multidimensional interventions on several health parameters in individuals with CPLBP. They will provide knowledge for pain management and functioning in affected individuals, which might diminish the need for primary healthcare services. Trial registration number: NCT06114264.
“健康背部”试验基于一种多模式干预措施，旨在确定一项有监督的体育锻炼、正念训练、行为改变和疼痛神经科学教育计划对慢性原发性下腰痛（CPLBP）患者的若干健康变量的有效性。该研究将是一项针对70名被诊断为CPLBP（年龄在18 - 65岁之间）个体的随机对照试验。干预将在医院环境中亲自进行，为期16周，包括第一阶段（16节有监督的体育锻炼（每周2天，每次45分钟）、正念训练（每周1天，每次2.5小时）、行为改变（通过佩戴在手腕上的活动提示设备每天/24小时进行）和疼痛神经科学教育（每两周1天，每次2小时））以及第二阶段（16节功能性全身肌肉强化锻炼，每周3天，每次50分钟）。主要结局将包括感知到的急性疼痛、疼痛压力阈值、条件性疼痛调制、疼痛的时间总和以及因疼痛导致的残疾。次要测量指标将包括身体素质、身体成分、步态参数、设备测量的身体活动和久坐行为、血液学指标、自我报告的久坐行为、生活质量、疼痛灾难化、心理健康、睡眠时间和质量，以及与中枢敏化相关的症状。各小组将在干预前（干预前）、干预后测试（干预各阶段后）和重新测试（干预后6周的停训期）进行测量。研究结果将确定多维度干预对CPLBP患者若干健康参数的有效性。它们将为受影响个体的疼痛管理和功能提供知识，这可能会减少对初级医疗服务的需求。试验注册号：NCT06114264。
