Multimodal mechanical stimulation reduces acute and chronic low back pain: Pilot data from a HEAL phase 1 study.

Multimodal mechanical stimulation reduces acute and chronic low back pain: Pilot data from a HEAL phase 1 study.
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DOI:
10.3389/fpain.2023.1114633
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发表时间:
2023
期刊:
Frontiers in pain research (Lausanne, Switzerland)
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其他
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有效的非阿片类药物疼痛管理具有重要的临床意义。这项初步研究的目的是评估多模式机械刺激治疗下腰痛的有效性。11名女性和9名男性患者,年龄22-74岁(平均41.9岁,SD 11.04),接受急性(12)或慢性(8)腰痛的物理康复治疗,选择热(9)或冰(11)伴随20分钟的机械刺激(M-Stim)治疗(注册于Clinicaltrials.gov NCT 04494841)。M-Stim通过三个振幅在0.1-0.3 m/s2之间的振动电机(50Hz、100 Hz、200 Hz)以12种可能的重复“治疗周期”模式输送。   10名患者使用了连接到导热单曲线金属板的封闭式电机底盘。接下来10名患者的器械的电机直接连接到多维弯曲接骨板上。第一种马达/接骨板配置的10 cm视觉模拟量表(VAS)的平均疼痛从4.9 ± 2.3 cm降至2.5 ± 2.1 cm(减少57%,p = 0.0112),而第二种配置的疼痛从4.8 ± 2.0 cm降至3.2 ± 1.9 cm(45%,p = 0.0353)。     急性损伤(5.8 ± 2.0 cm vs. 3.98 ± 1.8,p = 0.025)和40岁以上患者(5.44 vs. 4.52)的初始疼痛更大,但慢性和年轻患者的疼痛减轻成比例。 接骨板配置之间无显著差异。多电机多模式器械的I期临床试验研究有望实现无药物疼痛缓解。结果表明,疼痛缓解独立的热模态,患者年龄,或疼痛慢性。未来的研究应该调查随着时间的推移,急性和慢性疼痛的疼痛减轻。,标识符:NCT 04494841。
Effective non-opioid pain management is of great clinical importance. The objective of this pilot study was to evaluate the effectiveness of multimodal mechanical stimulation therapy on low back pain. 11 female and 9 male patients aged 22–74 years (Mean 41.9 years, SD 11.04) receiving physical rehabilitation for acute (12) or chronic (8) low back pain chose heat (9) or ice (11) to accompany a 20-minute session of mechanical stimulation (M-Stim) therapy (Registered with Clinicaltrials.gov NCT04494841.) The M-Stim was delivered in 12 possible repeating “therapy cycle” patterns by three vibration motors (50 Hz, 100 Hz, 200 Hz) with amplitudes between 0.1–0.3 m/s2. Ten patients used a contained motor chassis attached to a thermoconductive single-curve metal plate. The next 10 patients' device had motors attached directly to a multidimensionally curved plate. Mean pain on a 10 cm Visual Analog Scale (VAS) with the first motor/plate configuration went from 4.9 ± 2.3 cm to 2.5 ± 2.1 cm (57% decrease, p = 0.0112), while the second reduced pain from 4.8 ± 2.0 cm to 3.2 ± 1.9 cm (45%, p = 0.0353). Initial pain was greater with acute injury (5.8 ± 2.0 cm vs. 3.98 ± 1.8, p = 0.025) and for patients older than 40 (5.44 vs. 4.52), but pain reduction was proportional for chronic and younger patients. There was no significant difference between plate configurations. A Phase I clinical pilot investigation on a multi-motor multi-modal device was promising for drug free pain relief. Results suggested pain relief independent of thermal modality, patient age, or pain chronicity. Future research should investigate pain reduction over time for acute and chronic pain. , identifier: NCT04494841.
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