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光生物调节疗法联合运动控制训练对慢性非特异性下腰痛的影响:一项随机安慰剂对照试验方案

Effects of photobiomodulation therapy associated with motor control exercise for chronic non-specific low back pain: protocol for a randomised placebo-controlled trial.

作者信息

de Oliveira Marcelo Ferreira Duarte, Bjordal Jan Magnus, Schardong Jociane, Plentz Rodrigo Della Méa, Casalechi Heliodora Leão, Leal-Junior Ernesto Cesar Pinto, Tomazoni Shaiane Silva

机构信息

Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Post-graduate Program in Rehabilitation Sciences, Universidade Nove de Julho, Sao Paulo, Brazil.

Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.

出版信息

BMJ Open Sport Exerc Med. 2024 Sep 26;10(3):e002199. doi: 10.1136/bmjsem-2024-002199. eCollection 2024.

Abstract

Photobiomodulation therapy (PBMT), as an adjunct therapy to exercise, can reduce pain in musculoskeletal disorders. In addition, PBMT associated with exercise decreases fatigue, accelerates muscle recovery and enhances performance and gain through different training protocols. Although it has not been investigated, the association of PBMT and exercise therapy could be an alternative to improve the positive effects of exercise in patients with non-specific low back pain (LBP). Therefore, we aim to evaluate the effects of PBMT associated with motor control exercise (MCE) versus placebo associated with MCE in patients with chronic non-specific LBP. This is a prospectively registered, two-arm, randomised, placebo-controlled, triple-blind trial. A total of 148 patients with chronic non-specific LBP will be randomised to either active PBMT associated with MCE or placebo PBMT associated with MCE. Treatment sessions will be provided twice a week for 6 weeks. The primary outcomes will be pain intensity and general disability measured at the end of the treatment. The secondary outcomes will be pain intensity and general disability measured 1 month after the end of the treatment, 3, 6 and 12 months after randomisation, in addition to levels of prostaglandin E2 measured at the end of the treatment. Medication intake, cointerventions and adverse events will be measured at all time points. This study was approved by the Research Ethics Committee of Irmandade de Santa Casa de Misericórdia de Porto Alegre. The results will be disseminated through scientific publications and presentations at scientific meetings. Trial registration number: NCT05487118.

摘要

光生物调节疗法(PBMT)作为运动的辅助疗法,可减轻肌肉骨骼疾病中的疼痛。此外,与运动相关的PBMT可减轻疲劳、加速肌肉恢复,并通过不同的训练方案提高运动表现和增加肌肉量。尽管尚未进行研究,但PBMT与运动疗法相结合可能是改善非特异性下腰痛(LBP)患者运动积极效果的一种替代方法。因此,我们旨在评估与运动控制锻炼(MCE)相结合的PBMT与与MCE相结合的安慰剂相比,对慢性非特异性LBP患者的影响。这是一项前瞻性注册、双臂、随机、安慰剂对照、三盲试验。总共148例慢性非特异性LBP患者将被随机分为与MCE相结合的活性PBMT组或与MCE相结合的安慰剂PBMT组。治疗将每周进行两次,持续6周。主要结局指标将是治疗结束时测量的疼痛强度和总体功能障碍。次要结局指标将是治疗结束后1个月、随机分组后3个月、6个月和12个月测量的疼痛强度和总体功能障碍,以及治疗结束时测量的前列腺素E2水平。在所有时间点都将测量药物摄入量、联合干预措施和不良事件。本研究已获得阿雷格里港圣卡塔琳娜慈善会研究伦理委员会的批准。研究结果将通过科学出版物和在科学会议上的报告进行传播。试验注册号:NCT05487118。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0f5/11429343/afcbed33253a/bmjsem-10-3-g001.jpg

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