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

January 21, 2017 updated by: Fernanda Cordeiro da Silva, University of Nove de Julho

Evaluation of Sensory-motor Response to Low-level Laser Therapy for the Treatment of Spinal Injuries - Protocol for a Randomized, Controlled, Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

General objective - Evaluate the effect of LLLT on the sensory-motor response in individuals having suffered a spinal cord injury.

Specific objectives - Investigate the maintenance of the possible sensory-motor response through electromyographic analyses conducted before LLLT and as well as one, 15, 30, 45 and 60 days after the intervention; evaluate functional independence and quality of life in individuals having suffered a spinal cord injury.

Trial design - A randomized, controlled, clinical trial is proposed. displays the flowchart of the development of the study. The trial will be conducted in compliance with the norms governing research involving human subjects and will be submitted for the approval of the Institutional Review Board of University Nove de Julho, São Paulo, Brazil. All participants or their legal guardians will receive clarifications regarding the objectives and procedures of the study and those agreeing to participate will sign a statement of informed consent.

Methods: Participants, interventions and outcomes

Study setting - Physical Therapy Clinics of University Nove de Julho, São Paulo, Brazil Exclusion criteria: complete spinal cord injury, cognitive impairment.

Interventions - The volunteers will be randomly allocated to a control group or treatment group. Evaluations will be conducted before and after the intervention using electromyography of the myotome corresponding to the injured spinal nerve root. The treatment group will receive LLLT following the protocol outlined below:

LLLT protocol - Based on Byrnes et al. and Holanda et al., 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.

Recruitment Individuals will be recruited from the physical therapy clinics of University Nove de Julho (São Paulo, Brazil) as well as spinal injury associations, if necessary.

Methods: Assignment of interventions (for controlled trials)

Sequence generation The individuals will be allocated to the different groups based on numbers randomly generated by a computer program.

Allocation concealment mechanism Allocation will be concealed with the use of sealed opaque envelopes. Each envelope will be numbered on the outside and will contain the name of a participant on the inside. The envelopes will be randomly selected using a computer program, with the formation of the control group first, followed by the treatment group.

Implementation The volunteers will be enrolled in the research project of MSc. Fernanda Cordeiro da Silva and the envelopes will be prepared by researcher Paulo Roberto da Costa Palácio. Dr. Sandra Kalil Bussadori will head the project and will run the computer program for the random allocation of the volunteers to the different groups.

Blinding - There will be no blinding.

Methods: Data collection, management and analysis The data will be tabulated and treated using the SPSS 20.0 program for WindowsTM. The data will be submitted to descriptive statistical analysis. The chi-square test and Fisher's exact test will be used to establish the associations of the categorical variables. The Student's t-test will be used for the comparison of mean electromyographic signals. Pearson's correlation coefficients will be calculated for the analysis of the correlation of the continuous variables. The level of significance will be 95% (p < 0.05).

Ethics and dissemination

Research ethics approval - The trial will be conducted in compliance with the norms governing research involving human subjects and will be submitted for the approval of the Institutional Review Board of University Nove de Julho, São Paulo, Brazil. All participants or their legal guardians will receive clarifications regarding the objectives and procedures of the study and those agreeing to participate will sign a statement of informed consent.

Consent or assent - Researchers MSc. Fernanda Cordeiro da Silva and Paulo Roberto da Costa Palácio will present and explain the statement of informed consent to each volunteer. All participants will be informed with regard to the voluntary nature of participation and the possibility of withdrawing from the study at any time with no negative consequences.

Confidentiality - All data collected from the volunteers during the evaluations and treatments will be stored a hard drive to ensure confidentiality.

Declaration of interests - The authors declare no conflicts of interest. Access to data - Only the researchers directly involved in the study will have access to the data.

Ancillary and post-trial care - At the end of the study, all volunteers allocated to the control group will receive LLLT with the same protocol administered to the treatment group to avoid any inequality regarding treatment among the individuals.

Dissemination policy - The findings will be published in scientific journals and presented at conferences on the application of laser therapy and treatment for individuals with spinal injuries.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo/SP
      • São Paulo, São Paulo/SP, Brazil, 01.504-001
        • Recruiting
        • Universidade Nove de Julho
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electromyography
Time Frame: 15 days after the intervention
Pre and post-laser electromyography
15 days after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nove de Julho

Investigators

  • Principal Investigator: Fernanda C. da Silva, master, University of Nove de Julho

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ANTICIPATED)

May 1, 2017

Study Registration Dates

First Submitted

October 5, 2016

First Submitted That Met QC Criteria

January 21, 2017

First Posted (ESTIMATE)

January 25, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 21, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uni9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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