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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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 ).

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Brazil

Nove de Julho Universtiy

Sao Paulo, São Paulo, Brazil

Sponsors and Collaborators

University of Nove de Julho

Investigators

• Principal Investigator: Maria Cristina Chavantes, PhD; Nove de Julho University

More Information

Additional Information:

Related Info 

Publications:

Farrokhi MR, Vasei M, Fareghbal S, Farrokhi N. The effect of methylene blue on peridural fibrosis formation after laminectomy in rats: an experimental novel study. Spine J. 2011 Feb;11(2):147-52. doi: 10.1016/j.spinee.2011.01.014.

Yildiz KH, Gezen F, Is M, Cukur S, Dosoglu M. Mitomycin C, 5-fluorouracil, and cyclosporin A prevent epidural fibrosis in an experimental laminectomy model. Eur Spine J. 2007 Sep;16(9):1525-30. Epub 2007 Mar 27.

Temiz C, Temiz P, Sayin M, Ucar K. Effect of cepea extract-heparin and allantoin mixture on epidural fibrosis in a rat hemilaminectomy model. Turk Neurosurg. 2009 Oct;19(4):387-92.

Oehmichen M. Vitality and time course of wounds. Forensic Sci Int. 2004 Sep 10;144(2-3):221-31. Review.

Shah JM, Omar E, Pai DR, Sood S. Cellular events and biomarkers of wound healing. Indian J Plast Surg. 2012 May;45(2):220-8. doi: 10.4103/0970-0358.101282.

Wang R, Ghahary A, Shen Q, Scott PG, Roy K, Tredget EE. Hypertrophic scar tissues and fibroblasts produce more transforming growth factor-beta1 mRNA and protein than normal skin and cells. Wound Repair Regen. 2000 Mar-Apr;8(2):128-37.

Lee JH, Lee SH. Clinical effectiveness of percutaneous adhesiolysis using Navicath for the management of chronic pain due to lumbosacral disc herniation. Pain Physician. 2012 May-Jun;15(3):213-21.

Tao H, Fan H. Implantation of amniotic membrane to reduce postlaminectomy epidural adhesions. Eur Spine J. 2009 Aug;18(8):1202-12. doi: 10.1007/s00586-009-1013-x. Epub 2009 Apr 30.

Sobottke R, Schlüter-Brust K, Kaulhausen T, Röllinghoff M, Joswig B, Stützer H, Eysel P, Simons P, Kuchta J. Interspinous implants (X Stop, Wallis, Diam) for the treatment of LSS: is there a correlation between radiological parameters and clinical outcome? Eur Spine J. 2009 Oct;18(10):1494-503. doi: 10.1007/s00586-009-1081-y. Epub 2009 Jun 27.

Sandoval MA, Hernandez-Vaquero D. Preventing peridural fibrosis with nonsteroidal anti-inflammatory drugs. Eur Spine J. 2008 Mar;17(3):451-455. doi: 10.1007/s00586-007-0580-y. Epub 2008 Jan 3.

Rochkind S, Drory V, Alon M, Nissan M, Ouaknine GE. Laser phototherapy (780 nm), a new modality in treatment of long-term incomplete peripheral nerve injury: a randomized double-blind placebo-controlled study. Photomed Laser Surg. 2007 Oct;25(5):436-42.

Bae CS, Lim SC, Kim KY, Song CH, Pak S, Kim SG, Jang CH. Effect of Ga-as laser on the regeneration of injured sciatic nerves in the rat. In Vivo. 2004 Jul-Aug;18(4):489-95.

Keskın F, Esen H. Comparison of the effects of an adhesion barrier and chitin on experimental epidural fibrosis. Turk Neurosurg. 2010 Oct;20(4):457-63. doi: 10.5137/1019-5149.JTN.3205-10.2.

LaRocca H, Macnab I. The laminectomy membrane. Studies in its evolution, characteristics, effects and prophylaxis in dogs. J Bone Joint Surg Br. 1974 Aug;56B(3):545-50.

• 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
• 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:

Failed Back Surgery Syndrome; Postoperative Complications; Pathologic Processes; Back Pain; Pain; Neurologic Manifestations