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Evaluation of Sensory-motor Response to Low-level Laser Therapy for the Treatment of Spinal Injuries

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ClinicalTrials.gov Identifier: NCT03031223
Recruitment Status : Unknown
Verified January 2017 by Fernanda Cordeiro da Silva, University of Nove de Julho.
Recruitment status was:  Recruiting
First Posted : January 25, 2017
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Fernanda Cordeiro da Silva, University of Nove de Julho

Study Description
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Brief Summary:
Spinal cord injuries have become increasingly frequent due mainly to the increase in urban violence. The growing number of automobile collisions and violence-related events merits particular attention, as such occurrences can lead to death or disability stemming from a spinal injury. The severity of the consequences depends on the location affected and degree of destruction of afferent and efferent spinal cord pathways, with higher, more extensive injuries leading to less physical fitness and functional independence. Unfortunately, injured neurons of the central nervous system are unable to regenerate following a spinal injury and spinal cord regeneration is therefore a major challenge to researchers in the fields of neuroscience and neurologia. Upon receiving an external stimulus, the central nervous system is believed to adapt and reorganize itself using mechanisms to compensate for neuronal loss and promote, even if partially, the remodeling of remaining synaptic connections, leading to new neuronal sprouting. Low-level laser therapy (LLLT) has proven to be a possible option for the stimulation of the repair process in the central nervous system. It is plausible that this type of therapy can offer the same benefits previously established in other types of tissues, the stimulation of bone formation, neovascularization and the regeneration of peripheral nerves. Research groups have investigated the efficacy of LLLT for the treatment of spinal cord injuries and have demonstrated that laser therapy administered simultaneously to an injured sciatic nerve and corresponding segment of the spinal cord accelerates the regeneration process of the injured peripheral nerve.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Radiation: low-level laser therapy Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Sensory-motor Response to Low-level Laser Therapy for the Treatment of Spinal Injuries - Protocol for a Randomized, Controlled, Clinical Trial
Study Start Date : August 2016
Actual Primary Completion Date : January 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: low-level laser therapy

The treatment group will receive LLLT following the protocol outlined below:

LLLT protocol - radiance will be administered to the injury site transcutaneously at a wavelength of 808 nm using a Twin Flex Evolution diode laser (MMO Equipamento Opto-Eletronicos, Brazil). Twelve sessions will be held (three per week over four weeks). The dose administered to the surface of the skin will be 983 J/cm2 per session, with a treatment area of 4.72 W/cm² and total radiant energy of 25 J. According to the literature, this dose is capable of enhancing functional recovery following an injury.

 Radiation: low-level laser therapy
low-level laser therapy
Placebo Comparator: placebo
laser therapy is applied at low intensity without emitting radiation.
 Radiation: low-level laser therapy
low-level laser therapy


Outcome Measures
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Primary Outcome Measures :
  1. Electromyography [ Time Frame: 15 days after the intervention ]
    Pre and post-laser electromyography


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • partial spinal injury;
  • patients with tetraplegia or paraplegia;
  • injury between C3 and L5;
  • up to one year elapsed since injury.

Exclusion Criteria:

  • complete spinal cord injury;
  • cognitive impairment.
Contacts and Locations
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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): NCT03031223


Contacts
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Contact: Fernanda C. da Silva, master 005511968249579 fernandacordeiro@uninove.br
Contact: Sandra K. Bussadori, Doctor sandra.skb@gmail.com

Locations
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Brazil
Universidade Nove de Julho Recruiting
São Paulo, São Paulo/SP, Brazil, 01.504-001
Contact: Fernanda C. da Silva, master         
Sub-Investigator: Sandra K. Bussadori, Doctor         
Sub-Investigator: Paulo Roberto C. Palácio         
Principal Investigator: Fernanda C. da Silva, Master         
Sponsors and Collaborators
University of Nove de Julho
Investigators
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Principal Investigator: Fernanda C. da Silva, master University of Nove de Julho
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fernanda Cordeiro da Silva, Principal Investigator, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT03031223    
Other Study ID Numbers: Uni9
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Fernanda Cordeiro da Silva, University of Nove de Julho:
Spinal cord injuries
low-level laser therapy
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Back Injuries