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临床试验/NCT02529657
NCT02529657已完成不适用

Analysis of Effect of Low Level Laser Therapy in Spinal Surgery

University of Nove de Julho1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2013年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Immunochemistry to evaluate low level laser therapy anti-inflammatory mechanism 24 hours

研究概览

简要总结

Each year, more than one million individuals worldwide are submitted to laminectomies, with a failure rate higher than 40%. Postlaminectomy epidural adhesion is implicated as a main cause of ''failed back surgery syndrome'' and associated with increased risk of complications during revision surgery. The postoperative epidural scar can cause extradural compression or dural tethering, which results in recurrent radicular pain and physical impairment. Several studies in the literature are signalizing that Low-Level-Laser-Therapy (LLLT) is proven to be an effective tool to assist the inflammatory process and wound healing, as well to prevent infection. Thus, the objectives of this project are to delineate and evaluate the LLLT effects in spinal surgery. A prospective randomized, controlled trial with a total of 48 patients who underwent laminectomy, were divided into 2 groups. In the first group, 25 patients received LLLT during the surgical procedure over dura mater, over subcutaneous and on the skin, as well as 24h and 72h post surgery. In the second group, 23 patients were induced to think they will be getting the same treatment, although the laser is not operating. In those groups, C reactive protein, Lactate Dehydrogenase and Creatine kinase were evaluated in the second and fifth days after surgery, digital temperature will be measured and scores in visual analogue scale will be used, 5 minutes pre and 5 minutes post Laser application. The drainage output was collected in the first three days following surgery in both groups. Interleukins were evaluated in interstitial infiltrate drained in 24h and 48h. The data was 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
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients undergoing to lumbar laminectomy

排除标准

  • •Active lumbar cancer
  • •Infectious disease
  • •Coagulation disorders
  • •Dural injury during the surgery

研究组 & 干预措施

Placebo

Placebo Comparator

23 patients were induced to think they will be getting the same treatment, although the LLLT is not operating.

干预措施: Placebo (Procedure)

Low level Laser Therapy

Experimental

25 patients were submitted to spine surgery and have received low level laser therapy during surgery, 24 hours after surgery and 48 hours after surgery.

干预措施: Low Level Laser Therapy (Radiation)

结局指标

主要结局

Immunochemistry to evaluate low level laser therapy anti-inflammatory mechanism 24 hours

时间窗: 24 hours after surgery

Interstitial infiltrate obtained of Lumbar Drain collected 24 hours after surgery, interleukins IL-1, IL-4, IL-8, IL-10 and TNF alfa were measured through Immunochemistry, using ELISA.

Immunochemistry to evaluate low level laser therapy mechanism 48 hours after light delivery

时间窗: 48h after surgery

Interstitial infiltrate was obtained of Lumbar Drain collected 48 hours after surgery, in this infiltrate interleukins IL-1, IL-4, IL-8, IL10 and TNF alfa were measured through Immunochemistry, using ELISA.

次要结局

  • Score in Visual Analogue Scale(5 minutes post LLLT)
  • Score in Visual Analogue Scale(5 minutes pre LLLT)

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 (1)

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