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
|Condition or disease||Intervention/treatment||Phase|
|Failed Back Surgery Syndrome||Radiation: Low Level Laser Therapy Procedure: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
Placebo Comparator: Placebo
23 patients were induced to think they will be getting the same treatment, although the LLLT is not operating.
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 ).
- 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.
- 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.
- 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.
- Score in Visual Analogue Scale [ Time Frame: 5 minutes post LLLT ]Change from baseline in pain on the 11 point short pain scale.
- 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
- Values of Creatine Kinase in the blood [ Time Frame: pre operative, 24h and 48h postoperative ]Obtained through patient blood.
- 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
- 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
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
|Nove de Julho Universtiy|
|Sao Paulo, São Paulo, Brazil|
|Principal Investigator:||Maria Cristina Chavantes, PhD||Nove de Julho University|