Efficacy and Safety of Intermittent Negative Pressure Treatment on Spasticity and Spasticity-Related Symptoms in Patients with Multiple Sclerosis: A Two-Arm Randomized Trial.

IF 4.7 3区医学 Q1 CLINICAL NEUROLOGY

Neurology and Therapy Pub Date : 2026-10-01 Epub Date: 2026-07-15 DOI:10.1007/s40120-026-00985-1

Jesper Nørregaard, Henrik Hoel, Iacob Mathiesen, Sarah Haghighi, Marie Kierkegaard, Fredrik Piehl, Morten Blinkenberg, Kjell Morten Myhr

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引用次数: 0

Abstract

Introduction: To compare the efficacy of treatment with two different levels of intermittent negative pressure (INP), applied to the lower limb, on self-reported spasticity and pain in patients with multiple sclerosis (MS).

Methods: A randomized, two-arm multicenter trial enrolled patients with spasticity in the leg ≥ 4 on the numeric rating scale (NRS). Patients were randomized to treatment with -10 mmHg INP (low-dose group [LDG]) or -40 mmHg INP (high-dose group [HDG]) on the most affected leg, using the FlowOx 2.0 device (Otivio AS, Oslo, Norway). The device applies alternating cycles of 10 s of negative pressure and 7 s of ambient pressure via a sealed pressure chamber around the lower leg, for 1 h daily for 4 weeks.

Results: There was no difference in the change in NRS spasticity and pain score between the two groups after 4 weeks (estimated treatment effect 0.72; 95% CI [-0.17, 1.61]; p = 0.114, and 1.09; 95% CI [-0.35, 2.53]; p = 0.138, respectively). Both HDG and LDG experienced a statistically significant decrease in NRS spasticity compared with baseline (mean change -1.0; 95% CI [-1.6, -0.4]; p = 0.001, and mean change -1.6; 95% CI [-2.5, -0.6]; p = 0.002, respectively), and both groups had a significant decrease in NRS pain score compared with baseline (mean change -1.5; 95% CI [-2.6, -0.5]; p = 0.007, and mean change -3.0; 95% CI [-5.0, -1.0]; p = 0.006, respectively). No improvements in objective walking tests were observed. Treatment compliance was high, and device-related adverse events were mild to moderate.

Conclusion: There was no difference between treatment with a high and a low INP level in spasticity and pain. Both pressure levels led to significant improvements in spasticity and pain compared with baseline. INP treatment appears safe and may represent a useful non-pharmacological treatment option for spasticity in patients with MS.

Trial registration: ClinicalTrials.gov identifier NCT05562453.

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间歇性负压治疗多发性硬化症患者痉挛和痉挛相关症状的疗效和安全性：一项两组随机试验

前言：比较两种不同水平的间歇负压（INP）应用于下肢治疗多发性硬化症（MS）患者自我报告的痉挛和疼痛的疗效。方法：一项随机、双臂多中心试验纳入了腿部痉挛数值评定量表(NRS)≥4的患者。使用FlowOx 2.0装置（Otivio AS, Oslo, Norway），患者被随机分配到受影响最严重的腿上使用-10 mmHg INP（低剂量组[LDG]）或-40 mmHg INP（高剂量组[HDG]）。该装置通过小腿周围的密封压力室施加10秒的负压和7秒的环境压力交替循环，每天1小时，持续4周。结果：两组患者4周后NRS痉挛和疼痛评分变化无差异（估计治疗效果0.72;95% CI [-0.17, 1.61]; p = 0.114, 1.09; 95% CI [-0.35, 2.53]; p = 0.138）。与基线相比，HDG和LDG的NRS痉挛度均有统计学意义上的降低（平均变化-1.0;95% CI [-1.6, -0.4]; p = 0.001，平均变化-1.6;95% CI [-2.5, -0.6]; p = 0.002），两组NRS疼痛评分均较基线显著降低（平均变化-1.5;95% CI [-2.6, -0.5]; p = 0.007，平均变化-3.0;95% CI [-5.0, -1.0]; p = 0.006）。客观行走测试未见改善。治疗依从性高，器械相关不良事件轻至中度。结论：高、低INP治疗对痉挛和疼痛的影响无显著性差异。与基线相比，这两种压力水平都能显著改善痉挛和疼痛。INP治疗似乎是安全的，可能是ms患者痉挛的一种有用的非药物治疗选择。试验注册：ClinicalTrials.gov标识符NCT05562453。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Neurology and Therapy CLINICAL NEUROLOGY-

CiteScore

5.40

自引率

8.10%

发文量

103

审稿时长

6 weeks

期刊介绍： Aims and Scope Neurology and Therapy aims to provide reliable and inclusive, rapid publication for all therapy related research for neurological indications, supporting the timely dissemination of research with a global reach, to help advance scientific discovery and support clinical practice. Neurology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of neurological and psychiatric therapies, (also covering surgery and devices). Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial designs, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Neurology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research. Rapid Publication The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted, it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. 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