School of Health and Social Work, University of Hertfordshire, Hatfield, AL10 9AB, UK.
Primoris Contract Solutions Ltd, Ascot, SL5 0LW, UK.
BMC Geriatr. 2024 Aug 14;24(1):683. doi: 10.1186/s12877-024-05271-z.
Lower leg pain and symptoms, and poor leg circulation are common in older adults. These can significantly affect their function and quality of life. Neuromuscular electrical stimulation (NMES) applied via the feet as 'foot NMES' activates the leg musculovenous pump. This study investigated the effects of foot NMES administered at home using Revitive among community-dwelling older adults with lower leg pain and/or other lower leg symptoms such as cramps, or sensations of tired, aching, and heavy feeling legs.
A randomised placebo-controlled study with three groups (2 NMES, 1 Sham) and three assessments (baseline, week 8, week 12 follow-up) was carried out. Self-reported function using Canadian occupational performance measure (COPM), leg pain, overall leg symptoms score (heaviness, tiredness, aching, or cramps), and ankle blood flow were assessed. Analysis of covariance (ANCOVA) and logistic regression were used to compare the groups. Statistical significance was set at p < 0.05 (two-sided 5%).
Out of 129 participants enrolled, 114 completed the study. The improvement in all outcomes were statistically significant for the NMES interventions compared to Sham at both week 8 (p < 0.01) and week 12 (p < 0.05). The improvement in COPM met the minimal clinically important difference (MCID) for the NMES interventions compared to Sham at both week 8 (p < 0.005) and week 12 (p < 0.05). Improvement in leg pain met MCID at week 8 compared to Sham (p < 0.05). Ankle blood flow increased approximately 3-fold during treatment compared to Sham. Compliance with the interventions was high and no device-related adverse events were reported.
The home-based foot NMES is safe, and significantly improved self-reported function, leg pain and overall leg symptoms, and increased ankle blood flow compared to a Sham among older adults.
The trial was prospectively registered in ISRCTN on 17/06/2019 with registration number ISRCTN10576209. It can be accessed at https://www.isrctn.com/ISRCTN10576209 .
小腿疼痛和症状以及腿部血液循环不良在老年人中很常见。这些问题会严重影响他们的功能和生活质量。通过脚部施加的神经肌肉电刺激（NMES），即“脚部 NMES”，可以激活腿部的肌肉静脉泵。本研究调查了在社区居住的老年人中使用 Revitive 在家中进行脚部 NMES 治疗时的效果，这些老年人存在小腿疼痛和/或其他小腿症状，如抽筋，或感觉腿部疲劳、疼痛、沉重。
采用随机安慰剂对照研究，共设 3 组（2 个 NMES 组，1 个假刺激组）和 3 次评估（基线、第 8 周、第 12 周随访）。采用加拿大职业表现量表（COPM）评估自我报告的功能，小腿疼痛，总体腿部症状评分（沉重感、疲劳感、疼痛、或抽筋）和踝部血流。采用协方差分析（ANCOVA）和逻辑回归比较组间差异。统计学显著性水平设定为 p<0.05（双侧 5%）。
在纳入的 129 名参与者中，有 114 名完成了研究。与假刺激组相比，NMES 干预组在第 8 周（p<0.01）和第 12 周（p<0.05）时所有结局的改善均具有统计学意义。与假刺激组相比，NMES 干预组在第 8 周（p<0.005）和第 12 周（p<0.05）时 COPM 的改善达到了最小临床重要差异（MCID）。与假刺激组相比，第 8 周时小腿疼痛的改善达到了 MCID（p<0.05）。与假刺激组相比，踝部血流在治疗期间增加了约 3 倍。干预措施的依从性很高，没有报告与设备相关的不良事件。
与假刺激相比，基于家庭的脚部 NMES 安全且显著改善了老年人的自我报告功能、小腿疼痛和总体腿部症状，并增加了踝部血流。
该试验于 2019 年 6 月 17 日在 ISRCTN 进行了前瞻性注册，注册号为 ISRCTN10576209。可在 https://www.isrctn.com/ISRCTN10576209 上获取。
