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Low Level Laser Therapy to Reduce Comorbidity in Spinal Surgery (LASPINE)

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ClinicalTrials.gov Identifier: NCT02529657
Recruitment Status : Completed
First Posted : August 20, 2015
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Vanessa Milanesi Holanda, University of Nove de Julho

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.

Condition or disease Intervention/treatment Phase
Failed Back Surgery Syndrome Radiation: Low Level Laser Therapy Procedure: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Analysis of Effect of Low Level Laser Therapy in Spinal Surgery
Study Start Date : February 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : June 2018

Arm Intervention/treatment
Placebo Comparator: Placebo
23 patients were induced to think they will be getting the same treatment, although the LLLT is not operating.
Procedure: Placebo
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.

Experimental: Low level Laser Therapy
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
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 ).




Primary Outcome Measures :
  1. Immunochemistry to evaluate low level laser therapy anti-inflammatory mechanism 24 hours [ Time Frame: 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.

  2. Immunochemistry to evaluate low level laser therapy mechanism 48 hours after light delivery [ Time Frame: 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.


Secondary Outcome Measures :
  1. Score in Visual Analogue Scale [ Time Frame: 5 minutes pre LLLT ]
    Patient had to choose between 0 and 10 on the 11 point short pain scale.

  2. Score in Visual Analogue Scale [ Time Frame: 5 minutes post LLLT ]
    Change from baseline in pain on the 11 point short pain scale.


Other Outcome Measures:
  1. Temperature of the skin in the healing scar [ Time Frame: pre and 1 minute post LLLT ]
    Verified 1 minute before and 1 minute after LLLT

  2. Values of Creatine Kinase in the blood [ Time Frame: pre operative, 24h and 48h postoperative ]
    Obtained through patient blood.

  3. Values of C reactive protein in the blood [ Time Frame: pre operative, 24h and 48h postoperative ]
    Obtained through patient blood pre operative, 24h and 48h postoperative

  4. Values of Lactate dehydrogenase in the blood [ Time Frame: pre operative, 24h and 48h postoperative ]
    Obtained through patient blood pre operative, 24h and 48h postoperative



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Ages Eligible for Study:   10 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing to lumbar laminectomy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529657


Locations
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Brazil
Nove de Julho Universtiy
Sao Paulo, São Paulo, Brazil
Sponsors and Collaborators
University of Nove de Julho
Investigators
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Principal Investigator: Maria Cristina Chavantes, PhD Nove de Julho University
Additional Information:
Publications:

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Responsible Party: Vanessa Milanesi Holanda, MD, MS, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02529657    
Other Study ID Numbers: 12288113.1.0000.5511
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Keywords provided by Vanessa Milanesi Holanda, University of Nove de Julho:
Lower Level Laser Therapy (LLLT)
inflammation
cytokines
wound healing
laminectomy
clinical study
Additional relevant MeSH terms:
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Failed Back Surgery Syndrome
Postoperative Complications
Pathologic Processes
Back Pain
Pain
Neurologic Manifestations