Spinal Cord InjuriesNCT03031223
Evaluation of Sensory-motor Response to Low-level Laser Therapy for the Treatment of Spinal Injuries
A study testing low-level laser therapy in people with Spinal Cord Injuries, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- low-level laser therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- partial spinal injury;
- patients with tetraplegia or paraplegia;
- injury between C3 and L5;
- up to one year elapsed since injury.
Who cannot join
- complete spinal cord injury;
- cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Sandra K. Bussadori, Doctor contact
Brazil1 site, 1 recruiting
- Recruiting
Universidade Nove de Julho
São Paulo, São Paulo/SP, 01.504-001
Fernanda C. da Silva, master
Sandra K. Bussadori, Doctor
About this study
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
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- low-level laser therapy
- Keywords
- Spinal cord injuries, low-level laser therapy
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-level laser therapyRadiation
low-level laser therapy
| Study group | Role | What they receive |
|---|---|---|
| low-level laser therapy | Experimental | 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. Receives: Radiation: low-level laser therapy |
| placebo | Placebo comparator | laser therapy is applied at low intensity without emitting radiation. Receives: Radiation: low-level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography
Pre and post-laser electromyography
Measured: 15 days after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startAug 2016
- Primary completionJan 2017
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernanda Cordeiro da Silva, University of Nove de Julho
- Investigators
- Fernanda C. da Silva, master, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031223
- Sponsor's protocol ID
- Uni9
- Status last verified
- Jan 2017
- First submitted
- 5 Oct 2016
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
da Silva FC, Silva T, Gomes AO, da Costa Palacio PR, Andreo L, Goncalves MLL, Fatima Teixeira Silva D, Horliana ACRT, Motta LJ, Mesquita-Ferrari RA, Fernandes KPS, Bussadori SK. Sensory and motor responses after photobiomodulation associated with physiotherapy in patients with incomplete spinal cord injury: clinical, randomized trial. Lasers Med Sci. 2020 Oct;35(8):1751-1758. doi: 10.1007/s10103-020-02968-6. Epub 2020 Apr 26.
PubMed 32337679da Silva FC, Gomes AO, da Costa Palacio PR, Politti F, de Fatima Teixeira da Silva D, Mesquita-Ferrari RA, Fernandes KPS, Bussadori SK. Photobiomodulation improves motor response in patients with spinal cord injury submitted to electromyographic evaluation: randomized clinical trial. Lasers Med Sci. 2018 May;33(4):883-890. doi: 10.1007/s10103-018-2447-3. Epub 2018 Feb 13.
PubMed 29441450
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03031223
- Acronym / sponsor ID
- Uni9
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal cord injuries, low-level laser therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- May 2017 (estimated)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-level laser therapy | Experimental | Radiation: low-level laser therapyThe 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. |
| placebo | Placebo comparator | Radiation: low-level laser therapylaser therapy is applied at low intensity without emitting radiation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- partial spinal injury;
- patients with tetraplegia or paraplegia;
- injury between C3 and L5;
- up to one year elapsed since injury.
Key exclusion criteria (2 listed)
- complete spinal cord injury;
- cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-level laser therapylow-level laser therapy | Radiation | low-level laser therapy, placebo |
Primary outcome
Electromyography
Time frame: 15 days after the intervention
Pre and post-laser electromyography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Derived from this study: PubMed 32337679da Silva FC, Silva T, Gomes AO, da Costa Palacio PR, Andreo L, Goncalves MLL, Fatima Teixeira Silva D, Horliana ACRT, Motta LJ, Mesquita-Ferrari RA, Fernandes KPS, Bussadori SK. Sensory and motor responses after photobiomodulation associated with physiotherapy in patients with incomplete spinal cord injury: clinical, randomized trial. Lasers Med Sci. 2020 Oct;35(8):1751-1758. doi: 10.1007/s10103-020-02968-6. Epub 2020 Apr 26.
- Derived from this study: PubMed 29441450da Silva FC, Gomes AO, da Costa Palacio PR, Politti F, de Fatima Teixeira da Silva D, Mesquita-Ferrari RA, Fernandes KPS, Bussadori SK. Photobiomodulation improves motor response in patients with spinal cord injury submitted to electromyographic evaluation: randomized clinical trial. Lasers Med Sci. 2018 May;33(4):883-890. doi: 10.1007/s10103-018-2447-3. Epub 2018 Feb 13.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra K. Bussadori, Doctor contact
Fernanda C. da Silva, master principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-level laser therapy in people with Spinal Cord Injuries, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernanda C. da Silva, master (005511968249579, fernandacordeiro@uninove.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography (time frame: 15 days after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03031223, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2017.