Iversen Vegard Moe, Vasseljen Ottar, Mork Paul Jarle, Berthelsen Ida Reitan, Børke Janne-Birgitte Bloch, Berheussen Gro Falkener, Tveter Anne Therese, Salvesen Øyvind, Fimland Marius Steiro
Department of Public Health and General Practice, Norwegian University of Science and Technology, Trondheim, Norway.
Department of Physical Medicine and Rehabilitation, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.
Contemp Clin Trials Commun. 2017 Apr 12;6:115-121. doi: 10.1016/j.conctc.2017.04.001. eCollection 2017 Jun.
Chronic low back pain (LBP) is a major health problem worldwide. Multidisciplinary rehabilitation and exercise is recommended for the management of chronic LBP. However, there is a need to investigate effective exercise interventions that is available in clinics and as home-based training on a large scale. This article presents the design and rationale of the first randomized clinical trial investigating the effects of progressive resistance training with elastic bands in addition to multidisciplinary rehabilitation for patients with moderate to severe chronic LBP.
We aim to enroll 100 patients with chronic LBP referred to a specialized outpatient hospital clinic in Norway. Participants will be randomized equally to either; a) 3 tion including whole-body progressive resistance training using elastic bands - followed by home-based progressive resistance training for 9 weeks, or b) 3 weeks of multidisciplinary rehabilitation including general physical exercise - followed by home-based general physical exercise for 9 weeks. Questionnaires and strength tests will be collected at baseline, weeks 3 and 12, and at 6 and 12 months. The primary outcome is between-group changes in pain-related disability at week 12 assessed by the Oswestry disability index. Secondary outcomes include pain, work ability, work status, mental health, health-related quality of life, global rating of change, general health, and muscular strength and pain-related disability up to 12 months of follow-up.
This study will provide valuable information for clinicians working with patients with chronic LBP.
ClinicalTrials.gov, number NCT02420236.
慢性下腰痛是全球范围内的一个主要健康问题。多学科康复和运动被推荐用于慢性下腰痛的管理。然而，有必要研究在诊所和家庭训练中都能大规模开展的有效运动干预措施。本文介绍了第一项随机临床试验的设计和基本原理，该试验旨在研究除多学科康复外，使用弹力带进行渐进性抗阻训练对中重度慢性下腰痛患者的影响。
我们的目标是招募100名转诊至挪威一家专门门诊医院的慢性下腰痛患者。参与者将被随机平均分为两组：a）为期3周的全身渐进性抗阻训练，使用弹力带，随后进行为期9周的家庭渐进性抗阻训练；或b）为期3周的多学科康复，包括一般体育锻炼，随后进行为期9周的家庭一般体育锻炼。在基线、第3周和第12周以及6个月和12个月时收集问卷和力量测试数据。主要结局是在第12周时通过奥斯威斯残疾指数评估的组间疼痛相关残疾变化。次要结局包括疼痛、工作能力、工作状态、心理健康、健康相关生活质量、总体变化评分、一般健康状况以及长达12个月随访期内的肌肉力量和疼痛相关残疾。
本研究将为治疗慢性下腰痛患者的临床医生提供有价值的信息。
ClinicalTrials.gov，编号NCT02420236。
