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临床试验/NCT04347265
NCT04347265已完成不适用

Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain: a Pilot Study

University of Seville2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年5月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Level of pain

研究概览

简要总结

In our daily clinical practice, one of the most frequent reasons for consultation physiotherapists is low back pain (LBP). Regardless of the origin of the problem, the approach from physiotherapy contemplates the reduction of pain through different procedures, including neuromodulation.

In the field of Physiotherapy, ultrasound-guided Percutaneous Neuromodulation (PNM) is defined as the application through a needle with ultrasound guidance of an electrical current at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve in some point of its trajectory, or of a muscle in a motor point, with a therapeutic objective. The objective of this study is to analyze that the effect of PNM on the sciatic nerve produces statistically significant changes in pain, joint range and functionality in patients with chronic LBP. Thirty subjects will be recruited, which will be divided into 3 groups: group 1 to which PNM will be applied to the sciatic nerve in the gluteus region; group 2 to which PNM will be applied to the sciatic nerve in the middle of the thigh; and group 3 to which PNM will be applied to the sciatic nerve before popliteus region. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current (250 microseconds, 3 Hz) during 90 seconds

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Lower Back Pain
  • Having no other therapy

排除标准

  • Other pathology (discal hernia, injured limbs, neurological pathology)
  • Belenophobia

结局指标

主要结局

Level of pain

时间窗: From baseline measurement up to 1 week

Measured by Visual Analogue Scale (0, no pain; 100, max pain)

Y Balance Test

时间窗: From baseline measurement up to 1 week

Stability body

Owestry questionnaire

时间窗: From baseline measurement up to 1 week

Lower back pain questionnaire

Range of motion

时间窗: From baseline measurement up to 1 week

Measured by goniometer. Hip flexion, external and internal rotation range of motion

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Blanca de la Cruz Torres

Director

University of Seville

研究点 (2)

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