Clinical trial NCT02529657: Low Level Laser Therapy to Reduce Comorbidity in Spinal Surgery
Official title: Analysis of Effect of Low Level Laser Therapy in Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed Back Surgery Syndrome
Keywords: Lower Level Laser Therapy (LLLT)
inflammation
cytokines
wound healing
laminectomy
clinical study
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 48
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing to lumbar laminectomy

Exclusion Criteria:

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

Primary outcomes:
measure: Immunochemistry to evaluate low level laser therapy anti-inflammatory mechanism 24 hours
timeFrame: 24 hours after surgery
measure: Immunochemistry to evaluate low level laser therapy mechanism 48 hours after light delivery
timeFrame: 48h after surgery
Secondary outcomes:
measure: Score in Visual Analogue Scale
timeFrame: 5 minutes pre LLLT
measure: Score in Visual Analogue Scale
timeFrame: 5 minutes post LLLT
Other outcomes:
measure: Temperature of the skin in the healing scar
timeFrame: pre and 1 minute post LLLT
measure: Values of Creatine Kinase in the blood
timeFrame: pre operative, 24h and 48h postoperative
measure: Values of C reactive protein in the blood
timeFrame: pre operative, 24h and 48h postoperative
measure: Values of Lactate dehydrogenase in the blood
timeFrame: pre operative, 24h and 48h postoperative
Locations:
city: Sao Paulo
country: Brazil
facility: Nove de Julho Universtiy
state: São Paulo
Study officials:
affiliation: Nove de Julho University
name: Maria Cristina Chavantes, PhD
role: PRINCIPAL_INVESTIGATOR
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