Low Level Laser Therapy to Reduce Comorbidity in Spinal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Analysis of Effect of Low Level Laser Therapy in Spinal Surgery

Conditions
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Failed Back Surgery Syndrome

Intervention / Treatment
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* Radiation: Low Level Laser Therapy
* Procedure: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing to lumbar laminectomy Exclusion Criteria: Active lumbar cancer Infectious disease Coagulation disorders Dural injury during the surgery

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>23 patients were induced to think they will be getting the same treatment, although the LLLT is not operating. | Procedure: Placebo<br>* In the operating room, lumbar laminectomy will be performed in 46 patients. During the surgery, 24 hours and 48 hours after surgery, the patients received the regular treatment after laminectomy and were induced to thing that were receiving low level laser therapy in their wound.<br>|
| Experimental: Low level Laser Therapy<br>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. | Radiation: Low Level Laser Therapy<br>* In 23 randomized patients, LLLT (B-Cure, Good Energies ®, Israel), with CW diode laser - semiconductor Gallium Arsenide and aluminum (GaAlAs) will be applied during surgery (λ = 804 nm ± 2 , total exposure time of 240 s, energy density of 2.48 J/cm2 , average power of 40 mW , spot area of 3,876 cm2), in contact mode, for 60 seconds on the laminectomy site, 60 seconds and 120 seconds in the subcutaneous tissue of the skin over the wound bed, respectively. In the first and second day post surgery, will be collected the drainage output for analysis of interleukin 1, 4, 6, 8 and 10 (IL- 1, IL-4, IL -6, IL-8 and IL -10 ) and tumor necrosis factor alpha ( TNF -alpha ).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunochemistry to evaluate low level laser therapy anti-inflammatory mechanism 24 hours | 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. | 24 hours after surgery | 
| Immunochemistry to evaluate low level laser therapy mechanism 48 hours after light delivery | 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. | 48h after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score in Visual Analogue Scale | Patient had to choose between 0 and 10 on the 11 point short pain scale. | 5 minutes pre LLLT | 
| Score in Visual Analogue Scale | Change from baseline in pain on the 11 point short pain scale. | 5 minutes post LLLT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower Level Laser Therapy (LLLT), inflammation, cytokines, wound healing, laminectomy, clinical study