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

NCT03031223 | Unknown DMC

• 1 other identifier: Uni9
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Spinal cord injuries; low-level laser therapy

Outcome Measures

Primary Outcomes (1)

• Electromyography

  Pre and post-laser electromyography

  15 days after the intervention

Study Arms (2)

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.

Radiation: low-level laser therapy

placebo

PLACEBO COMPARATOR

laser therapy is applied at low intensity without emitting radiation.

Radiation: low-level laser therapy

Interventions

low-level laser therapy RADIATION

low-level laser therapy

low-level laser therapy; placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• complete spinal cord injury;
• cognitive impairment.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Universidade Nove de Julho

São Paulo, São Paulo/SP, 01.504-001, Brazil

RECRUITING

Related Publications (2)

• 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.

  PMID: 32337679 DERIVED

• da 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.

  PMID: 29441450 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Fernanda C. da Silva, master

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernanda C. da Silva, master

CONTACT

005511968249579; fernandacordeiro@uninove.br

Sandra K. Bussadori, Doctor

CONTACT

sandra.skb@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: January 25, 2017
• Study Start: August 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: May 1, 2017
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

BR (1)