Low Level Laser Therapy to Reduce Comorbidity in Spinal Surgery
Condition: Failed Back Surgery Syndrome
MeSH terms: Failed Back Surgery Syndrome
Study type: Interventional

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.
    


Intervention name(s): Low Level Laser Therapy; Placebo
Intervention type(s): Radiation; Procedure
Intervention description(s): 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 ).; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Lower Level Laser Therapy (LLLT); inflammation; cytokines; wound healing; laminectomy; clinical study