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Completed

NCT Number: NCT02529657

Low Level Laser Therapy to Reduce Comorbidity in Spinal Surgery

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.

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Key information

Age range

10 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nove de Julho Universtiy

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing to lumbar laminectomy

Exclusion criteria

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

Treatment and study plan

Low level laser therapy

Radiation

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 ).

Placebo

Procedure

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

Analysis of Effect of Low Level Laser Therapy in Spinal Surgery

Acronym: LASPINE

Important dates

Study start
2013
Primary completion
2015
Study completion
2018
First posted
Aug 20, 2015
Registry last updated
Jun 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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