VA Portland Health Care System, 3710 SW US Veterans Hospital Rd. R&D 27, Portland, OR, 97239, USA.
Department of Neurology, Oregon Health & Science University, 3303 SW Sam Jackson Park Rd. L226, Portland, OR, 97239, USA.
BMC Neurol. 2020 Oct 7;20(1):368. doi: 10.1186/s12883-020-01902-1.
Spasticity affects 60-80% of people with multiple sclerosis (MS), impacting activity, participation and quality of life. We developed the group delivered spasticity self-management program, "MS Spasticity: Take Control" (STC), with DVDs for education and lower extremity stretching. STC is based on an international guideline and recommendations from systematic reviews and emphasizes the importance of stretching with specific stretching exercises. Our pilot trial (n = 38) compared STC followed by one month of home stretching practice to unguided use of the National MS Society (NMSS) brochure titled "Stretching for People with MS: An Illustrated Manual," also followed by one month of home stretching practice. In this pilot trial, STC showed promising effects on the impact of spasticity (MS Spasticity Scale-88) and other self-report and physical performance measures. We will now carry out a fully-powered trial to evaluate the effect of STC compared to a comparably delivered control program on the impact and severity of spasticity in people with MS and self-reported lower extremity spasticity.
Two hundred-twenty ambulatory adults with MS self-reported spasticity interfering with daily activities will be randomized 1:1 to STC or control, using the same NMSS brochure used in the pilot study, with both programs delivered in groups with trained facilitators. Outcomes are the impact of spasticity with the MS Spasticity Scale-88, the severity of spasticity with the Numeric Rating Scale for Spasticity, other self-report questionnaires, and physical performance walking measures at baseline and one and 6 months after the interventions.
Stretching is the cornerstone of spasticity management. Stretching takes time and energy every day. Unfortunately, beyond the logical expectation that regular stretching should help prevent muscle shortening and contractures in the presence of spasticity, there is very little data on the effects of stretching on spasticity in people with MS or any other condition. Our pilot trial of STC suggested that education and stretching help reduce the impact of spasticity. To definitively determine if this education and instructional program with daily stretching practice is effective, a fully powered trial with a comparable control intervention and facilitators who did not create STC is needed. Here we report the protocol for this trial.
NCT03166930 May 25, 2017.
痉挛影响了 60-80%多发性硬化症（MS）患者，影响了他们的活动、参与和生活质量。我们开发了团体提供的痉挛自我管理计划“多发性硬化症痉挛：掌控（STC）”，其中包括用于教育和下肢伸展的 DVD。STC 基于国际指南以及系统评价的建议，强调了使用特定伸展运动进行伸展的重要性。我们的初步试验（n=38）比较了 STC 后一个月的家庭伸展练习与无指导使用国家多发性硬化症协会（NMSS）小册子“伸展对多发性硬化症患者：插图手册”的使用，后者也进行了一个月的家庭伸展练习。在这个初步试验中，STC 显示出在痉挛影响（多发性硬化症痉挛量表-88）和其他自我报告和身体表现措施方面有良好的效果。现在，我们将开展一项全面的试验，以评估 STC 与以类似方式提供的对照方案相比，对多发性硬化症患者痉挛的影响和严重程度以及自我报告的下肢痉挛的影响。
220 名有日常活动障碍的多发性硬化症活动患者自我报告有痉挛，将被随机分为 1:1 至 STC 或对照，使用与初步研究中相同的 NMSS 小册子，两组均由接受过培训的促进者提供。主要结局是使用多发性硬化症痉挛量表-88 评估痉挛的影响，使用数字评定量表评估痉挛的严重程度，以及其他自我报告的问卷和干预后 1 个月和 6 个月的身体表现步行测量。
伸展是痉挛管理的基石。伸展需要每天花费时间和精力。不幸的是，除了定期伸展应该有助于预防痉挛存在时肌肉缩短和挛缩的逻辑预期之外，关于伸展对多发性硬化症患者或任何其他疾病痉挛的影响的数据非常有限。我们的 STC 初步试验表明，教育和伸展有助于减轻痉挛的影响。为了确定这种教育和有日常伸展练习的指导方案是否有效，需要进行一项有类似对照干预和未创建 STC 的促进者的全面试验。这里我们报告了该试验的方案。
NCT03166930 于 2017 年 5 月 25 日注册。
