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

Primary Purpose

Failed Back Surgery Syndrome

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Low Level Laser Therapy
Placebo
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Failed Back Surgery Syndrome focused on measuring Lower Level Laser Therapy (LLLT), inflammation, cytokines, wound healing, laminectomy, clinical study

Eligibility Criteria

10 Years - 90 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients undergoing to lumbar laminectomy

Exclusion Criteria:

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

Sites / Locations

  • Nove de Julho Universtiy

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Low level Laser Therapy

Arm Description

23 patients were induced to think they will be getting the same treatment, although the LLLT is not operating.

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.

Outcomes

Primary Outcome Measures

Immunochemistry to evaluate low level laser therapy anti-inflammatory mechanism 24 hours
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
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

Score in Visual Analogue Scale
Patient had to choose between 0 and 10 on the 11 point short pain scale.
Score in Visual Analogue Scale
Change from baseline in pain on the 11 point short pain scale.

Full Information

First Posted
November 22, 2013
Last Updated
June 14, 2018
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT02529657
Brief Title
Low Level Laser Therapy to Reduce Comorbidity in Spinal Surgery
Acronym
LASPINE
Official Title
Analysis of Effect of Low Level Laser Therapy in Spinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Back Surgery Syndrome
Keywords
Lower Level Laser Therapy (LLLT), inflammation, cytokines, wound healing, laminectomy, clinical study

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
23 patients were induced to think they will be getting the same treatment, although the LLLT is not operating.
Arm Title
Low level Laser Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Low Level Laser Therapy
Intervention Description
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 ).
Intervention Type
Procedure
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Immunochemistry to evaluate low level laser therapy anti-inflammatory mechanism 24 hours
Description
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.
Time Frame
24 hours after surgery
Title
Immunochemistry to evaluate low level laser therapy mechanism 48 hours after light delivery
Description
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.
Time Frame
48h after surgery
Secondary Outcome Measure Information:
Title
Score in Visual Analogue Scale
Description
Patient had to choose between 0 and 10 on the 11 point short pain scale.
Time Frame
5 minutes pre LLLT
Title
Score in Visual Analogue Scale
Description
Change from baseline in pain on the 11 point short pain scale.
Time Frame
5 minutes post LLLT
Other Pre-specified Outcome Measures:
Title
Temperature of the skin in the healing scar
Description
Verified 1 minute before and 1 minute after LLLT
Time Frame
pre and 1 minute post LLLT
Title
Values of Creatine Kinase in the blood
Description
Obtained through patient blood.
Time Frame
pre operative, 24h and 48h postoperative
Title
Values of C reactive protein in the blood
Description
Obtained through patient blood pre operative, 24h and 48h postoperative
Time Frame
pre operative, 24h and 48h postoperative
Title
Values of Lactate dehydrogenase in the blood
Description
Obtained through patient blood pre operative, 24h and 48h postoperative
Time Frame
pre operative, 24h and 48h postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients undergoing to lumbar laminectomy Exclusion Criteria: Active lumbar cancer Infectious disease Coagulation disorders Dural injury during the surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Cristina Chavantes, PhD
Organizational Affiliation
Nove de Julho University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nove de Julho Universtiy
City
Sao Paulo
State/Province
São Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
21296299
Citation
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PubMed Identifier
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Citation
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Citation
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PubMed Identifier
23162220
Citation
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PubMed Identifier
10810039
Citation
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Citation
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PubMed Identifier
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Citation
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Links:
URL
http://aplicacao.saude.gov.br/plataformabrasil/visao/pesquisador/gerirPesquisa/gerirPesquisa.jsf
Description
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Low Level Laser Therapy to Reduce Comorbidity in Spinal Surgery

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