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临床试验/NCT03248505
NCT03248505Unknown不适用

Immediate Effects of Conventional TENS and Burst TENS Combined With Cryotherapy in the Non-specific Low Back Pain

Universidade Federal do Rio Grande do Norte2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年5月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
120
试验地点
2
主要终点
Painful sensation

研究概览

简要总结

This study aim analyze the immediate effects of conventional transcutaneous electrical nerve stimulation (TENS) and Burst TENS combined or not with cryotherapy in patients with non-specific low back pain.

All subjects will be submitted to an evaluation of the painful sensation, through the numerical rating scale, and pain threshold, through algometry, before, immediately after the intervention and 25 minutes after.

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
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 18 and 50 years;
  • Have chronic non-specific low back pain.

排除标准

  • Serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as ankylosing spondylitis);
  • Nerve root compromise (disc herniation and spondylolisthesis with neurological compromise, spinal stenosis, and others);
  • Fibromyalgia
  • Corticosteroid treatment in the previous two weeks;
  • Antiinflammatory treatment in the previous 24 hours;
  • Contraindications to the use of Kinesio Taping (allergy or intolerance);
  • Score of three or less on Visual Analogue Scale of the first day;
  • Pregnancy;
  • Ice allergy.

研究组 & 干预措施

Placebo TENS

Placebo Comparator

TENS unit turned on, but with zero amplitude.

干预措施: Placebo TENS (Other)

Conventional TENS

Experimental

Symmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude.

干预措施: Conventional TENS (Device)

Burst TENS

Experimental

Carrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude.

干预措施: Burst TENS (Device)

Cryotherapy

Experimental

1,5 Kg crushed ice pack

干预措施: Cryotherapy (Other)

Burst TENS + Cryotherapy

Experimental

Carrier frequency of 100 Hz burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude plus an ice pack of 1,5 Kg.

干预措施: Burst TENS + Cryotherapy (Device)

Conventional TENS + Cryotherapy

Experimental

Symmetrical biphasic pulsed current, with frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude plus an ice pack of 1,5 Kg.

干预措施: Conventional TENS + Cryotherapy (Device)

结局指标

主要结局

Painful sensation

时间窗: Evaluation of pain sensation 25 minutes after the application of the intervention.

Pain sensation measured by pain numerical rating scale

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

Jamilson Simões Brasileiro

Professor of Physiotherapy

Universidade Federal do Rio Grande do Norte

研究点 (2)

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