How we Apply Ultrasound-guided Neuromodulation in Lower Back Pain Sufferers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Range of motion
研究概览
简要总结
In the 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 the 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. Forty subjects will be recruited, which will be divided into 2 groups: group 1 to which PNM will be applied to the sciatic nerve at 250 microseconds, 3 Hz) during 90 seconds; group 2 to which PNM will be applied to the sciatic nerve in at 250 microseconds, 10 Hz during 90 second. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current.
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, Care Provider, 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
- 是
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
研究组 & 干预措施
NMP 3 Hz
Participants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, with 3 Hz frequency and a 250µs pulse width, at the maximal tolerable intensity, to cause an tolerable muscle contraction. The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations. A trained physiotherapist performed the PNM intervention.
干预措施: NMP (Other)
NMP 10 Hz
Participants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, with 10 Hz frequency and a 250µs pulse width, at the maximal tolerable intensity, to cause an tolerable muscle contraction. The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations. A trained physiotherapist performed the PNM intervention.
干预措施: NMP (Other)
结局指标
主要结局
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
Level of pain
时间窗: From baseline measurement up to 1 week
Measured by Visual Analogue Scale (0, no pain; 100, max pain)
Strength
时间窗: From baseline measurement up to 1 week
Measured by dynamometer. Hip flexion, abduction, external and internal rotation muscle strength
Owestry questionnaire
时间窗: From baseline measurement up to 1 week
Lower back pain questionnaire. The final result is classified as minimal disability (0-20), moderate disability (21-40), severe disability (41-60), crippled (61-80) and bed-bound or exaggerating their symptoms (81-100).
Y Balance Test
时间窗: From baseline measurement up to 1 week
Stability body
次要结局
未报告次要终点
研究者
Blanca de la Cruz Torres
Principal Investigator
University of Seville