Adjunctive tonic motor activation enables opioid reduction for refractory restless legs syndrome: a prospective, open-label, single-arm clinical trial.
Adjunctive tonic motor activation enables opioid reduction for refractory restless legs syndrome: a prospective, open-label, single-arm clinical trial.
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辅助紧张性运动激活使难治性不宁腿综合征的阿片类药物减少：一项前瞻性、开放标签、单臂临床试验。
DOI：
10.1186/s12883-023-03462-6
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发表时间：
2023-11-21
期刊：
影响因子：
2.6
通讯作者：
Charlesworth, Jonathan D.
中科院分区：
文献类型：
--
作者：
Buchfuhrer, Mark J.;Roy, Asim;Rodriguez, Stephanye;Charlesworth, Jonathan D.
关键词：
对药物的难治性，有大量的腿部综合症（RLS）患者，而专家建议非标签的阿片类药物作为难治性RLS的有效长期治疗，减少阿片类药物可以大大减少副作用和风险激活（TOMAC）是一种非药理学治疗装置，用于此处的难治性RL。 RLS。
这项前瞻性，开放标签的单臂临床试验[NCT04698343]招募了20名成年人每天服用≤60毫米的吗啡毫克等效物（MME），用于自我管理的RLS，自助式30分钟的tomac tomactions在RLS象征中均匀地训练。在TOMAC治疗期间，阿片类药物剂量每2-3周迭代降低，直到临床医生全球改善印象（CGI-I）相对于基线超过5的得分。主要终点是成功降低阿片类药物剂量≥20％的参与者的百分比。次要终点包括平均成功降低CGI-I 5的成功百分比阿片类药物剂量。
平均而言，参与者对3.2药物（SD 1.6）耐火，并服用稳定剂量的阿片类药物（SD 3.9）（SD 3.9）。 CGI-I≤5。与CGI-I≤5降低阿片类药物的平均百分比为29.9％（SD 23.7％，n = 20），从39.0到26.8 mme。减少剂量为4.0（SD 1.4），表明RLS严重程度没有变化。
对于难治性RLS，Tomac启用了大量的阿片类药物剂量，而无需增加RLS症状。
Clinicaltrials.gov试验号NCT04698343于2021年1月6日注册。
在线版本中包含10.1186/s12883-023-03462-6的补充材料。
There is a large population of restless legs syndrome (RLS) patients who are refractory to medication. Whereas experts recommend off-label opioids as an effective long-term treatment for refractory RLS, reducing opioid dose could substantially reduce side effects and risks. Tonic motor activation (TOMAC) is a nonpharmacological therapeutic device indicated for refractory RLS. Here, we investigated if TOMAC could enable opioid dose reduction for refractory RLS. This prospective, open-label, single-arm clinical trial [NCT04698343] enrolled 20 adults taking ≤ 60 morphine milligram equivalents (MMEs) per day for refractory RLS. Participants self-administered 30-min TOMAC sessions bilaterally over the peroneal nerve when RLS symptoms presented. During TOMAC treatment, opioid dose was reduced iteratively every 2–3 weeks until Clinician Global Impression of Improvement (CGI-I) score relative to baseline exceeded 5. Primary endpoint was percent of participants who successfully reduced opioid dose ≥ 20% with CGI-I ≤ 5. Secondary endpoints included mean successful percent opioid dose reduction with CGI-I ≤ 5. On average, participants were refractory to 3.2 medications (SD 1.6) and were taking a stable dose of opioids for 5.3 years (SD 3.9). Seventy percent of participants (70%, 14 of 20) successfully reduced opioid dose ≥ 20% with CGI-I ≤ 5. Mean percent opioid dose reduction with CGI-I ≤ 5 was 29.9% (SD 23.7%, n = 20) from 39.0 to 26.8 MME per day. Mean CGI-I score at the reduced dose was 4.0 (SD 1.4), indicating no change to RLS severity. For refractory RLS, TOMAC enabled substantial opioid dose reduction without increased RLS symptoms. These results suggest that TOMAC has the potential to reduce the risk profile associated with opioid therapy for refractory RLS. ClinicalTrials.gov trial number NCT04698343 registered on January 6, 2021. The online version contains supplementary material available at 10.1186/s12883-023-03462-6.
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