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临床试验/NCT02529670
NCT02529670已完成不适用

Study of the Effect of Low Level Laser Therapy in the Dorsal Root Ganglion in the Diagnosis and Treatment of Chronic Low Back Pain

University of Nove de Julho2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
Pain Intensity Measure using the change in Visual Analog Scale from baseline at 1 month

研究概览

简要总结

Chronic axial low back pain is a public health problem and has a high socioeconomic impact. The dorsal ganglion of the second spinal nerve (GDL2) is a cluster of neuronal bodies responsible for sensory afferent inputs from more than 80% of the lumbar region. Low-level laser therapy (LLLT) is proven effective to help relieve pain. Thus, the aim of this project is to determine the effect of LLLT on GDL2 when applied to assist in the diagnosis and treatment of chronic axial low back pain. Methodology: 45 patients will be randomized into three groups: laser, radiofrequency and local anesthetic. The patient will be positioned in a prone horizontal position under anesthetic monitoring. The intervertebral foramen between the second and third lumbar vertebrae will be accessed by percutaneous puncture guided by fluoroscopy. In the local anesthetic group, injection of 1 ml lidocaine without vasoconstrictor will be applied in the tubes G20, 150 mm long and 5 mm active tip in contact with the target. In the radiofrequency group, neuromodulation will be held for 300 seconds at 42oC. In the laser group, the laser Photon III® (DCM) will be applied through optic fiber crossing G18 cannulas, during 84 seconds. The pain score will be assessed by visual analog scale. Temperature will be measured and aspirate periganglionic sample, trans-operatively, to study Interleucins-1β and TNF-alpha assessed by ELISA and genetic evaluation trough RNA seek, RNA isolation and ATP quantification. The data will be evaluated for normality and subjected to appropriate statistical analysis, in order to seek representation, as same as the level of significance of the studied samples.

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
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic low back pain (more than 3 months of nociceptive or neuropathic pain).
  • No neurological deficits

排除标准

  • Active lumbar cancer
  • Active infection
  • Coagulation disorders

结局指标

主要结局

Pain Intensity Measure using the change in Visual Analog Scale from baseline at 1 month

时间窗: 5 minutes after procedure

Patients will report the intensity of the pain using the score in visual analogue scale, scored 0-10 (0=no pain; 10=the worst pain ever).

Pain Intensity Measure using Visual Analog Scale

时间窗: 5 minutes before procedure

Self reported pain intensity following Visual Analog Scale, scored 0-10 (0=no pain; 10=the worst pain ever).

Pain Intensity Measure using the Visual Analog Scale

时间窗: 1 month and 6 months after procedure

In follow up, patients will report the intensity of the pain using the score in visual analogue scale, scored 0-10 (0=no pain; 10=the worst pain ever).

次要结局

  • Immunochemistry to analyse IL-1, IL-10, TNF alfa.(Samples collected 1 minute after the application of laser, radiofrequency or lidocaine)

研究者

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

Vanessa Milanesi Holanda

MD, MS

University of Nove de Julho

研究点 (2)

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