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神经管理联合基于临床指标的积极建议和坐骨神经动态治疗对慢性坐骨神经痛患者的效果:一项对照随机临床试验研究方案。

Neural management plus advice to stay active on clinical measures and sciatic neurodynamic for patients with chronic sciatica: Study protocol for a controlled randomised clinical trial.

机构信息

Rehabilitation Science Postgraduation Program, Augusto Motta University Centre (UNISUAM), Rio de Janeiro, Brazil.

Institute for Musculoskeletal Health, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.

出版信息

PLoS One. 2022 Feb 4;17(2):e0263152. doi: 10.1371/journal.pone.0263152. eCollection 2022.

Abstract

Advice to stay active is the primary management strategy for sciatica. Other conservative treatments such as neural management techniques may also contribute to sciatica recovery, but currently, the effects have not been robustly assessed. Thus, the aim of this study is to compare the effects of adding neural management to advice to stay active versus advice to stay active alone in improving pain intensity and functional limitation. Secondarily, to compare the effects of the experimental intervention in the sciatic neurodynamic, pain modulation, and psychosocial factors. A parallel-group, controlled, examiner-blinded superiority clinical trial randomised at a 1:1 allocation will be conducted in 210 participants with chronic sciatica. Patients will be recruited from outpatient physiotherapy clinics and community advertisements. The experimental group will receive neural mobilisation techniques and soft tissue mobilisation techniques for 30 minutes per session, 10 weekly sessions, plus advice to stay active on their activities of daily living, information on physical activity, imaging tests, and sciatica for 5 biweekly sessions lasting 25-30 minutes. The control group will receive advice to stay active only. The re-evaluation will be performed out after 5 weeks, 10 weeks, and 26 weeks after randomisation and primary endpoints will be pain intensity and functional limitation at 10 weeks. Secondary outcomes will include neuropathic symptoms, sciatic neurodynamic, pain modulation, and psychosocial factors. Adverse events and patient satisfaction will be assessed. Ethical approval has been granted from an Institutional Human Research Ethics Committee. Trial registration: Trial was prospectively registered in the Brazilian Registry of Clinical Trials (number: RBR-3db643c).

摘要

对于坐骨神经痛,建议保持活动是主要的管理策略。其他保守治疗方法,如神经管理技术,也可能有助于坐骨神经痛的恢复,但目前,其效果尚未得到有力评估。因此,本研究的目的是比较在保持活动的建议中添加神经管理与单独保持活动的建议在改善疼痛强度和功能限制方面的效果。其次,比较实验干预对坐骨神经动力学、疼痛调节和心理社会因素的影响。一项平行组、对照、观察者盲法优势临床试验将在 210 名慢性坐骨神经痛患者中进行,采用 1:1 分配。患者将从门诊物理治疗诊所和社区广告中招募。实验组将接受神经松动技术和软组织松动技术,每次 30 分钟,每周 10 次,以及日常生活活动中的保持活动建议、关于体育活动、影像学检查和坐骨神经痛的信息,共 5 次,每次 25-30 分钟,持续 5 周。对照组仅接受保持活动的建议。重新评估将在随机分组后 5 周、10 周和 26 周进行,主要终点是 10 周时的疼痛强度和功能限制。次要结局包括神经病变症状、坐骨神经动力学、疼痛调节和心理社会因素。将评估不良事件和患者满意度。该试验已获得机构人类研究伦理委员会的伦理批准。试验已在巴西临床试验注册处(注册号:RBR-3db643c)进行了前瞻性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a222/8815873/38e99e2e69ca/pone.0263152.g001.jpg

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