Immediate Effect of Irradiation With Low-level Laser Therapy on the Electromyographic Activity of the Upper Trapezius Muscles and the Level of Pain Among Patients With Non-specific Neck Pain

NCT ID: NCT02498249

Last Updated: 2015-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-07-31

Brief Summary

The aim of the present study is to assess the immediate effect of irradiation with low level laser therapy (LLLT) on the electromyographic activity of upper trapezius muscles and the amount of pain felt by patients with non-specific neck pain (NS-NP).A total of 20 patients with non-specific neck pain will be enrolled in a randomized, single-blind, crossover study. Each subject will receive two forms of treatment in random order: a single session of LLLT and placebo LLLT. In order to eliminate carry-over treatment effects, a one-week wash-out period will be respected between sessions. Surface electromyography will be used to determine nerve conduction velocity and activity in the upper trapezius muscles before and after treatment. The outcome measures will be determined by a numerical pain rating scale. Comparisons before and after irradiation with LLLT will determine the activity of the upper trapezius muscles and the level of pain. The data will be submitted to statistical tests considering a p-value of p < 0.05.

Conditions

Neck Pain Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental: low level laser therapy (LLLT)

For the LLLT irradiation, a paper template with 9 points (area of 1cm and a distance from center to center of 1 cm) will be used, distributed in three columns and three lines. The central point of the template will be positioned above the medium point of a line traced between the acromion and the spinous process of the seventh cervical vertebra, where the treatment should be close to the fixation point of the EMG electrode. The application point of the LLLT was determined by the location of the innervation point of the upper trapezius muscle.

Individuals will be subject to application of low level laser with a total dose of 18 J

Group Type: EXPERIMENTAL

low level laser therapy

Intervention Type: DEVICE

Will be performed irradiation with low-intensity laser in upper trapezius muscle

Experimental: Placebo low level laser therapy (PLLLT)

For the PLLLT irradiation, a paper template with 9 points (area of 1cm and a distance from center to center of 1 cm) will be used, distributed in three columns and three lines. The central point of the template will be positioned above the medium point of a line traced between the acromion and the spinous process of the seventh cervical vertebra, where the treatment should be close to the fixation point of the EMG electrode. The application point of the PLLLT was determined by the location of the innervation point of the upper trapezius muscle.

Individuals will be subject to application of low level laser with a total dose of 0 J

Group Type: PLACEBO_COMPARATOR

Placebo low level laser therapy

Intervention Type: DEVICE

Will be not performed irradiation with low-intensity laser in upper trapezius muscle

Interventions

low level laser therapy

Will be performed irradiation with low-intensity laser in upper trapezius muscle

Intervention Type: DEVICE

Placebo low level laser therapy

Will be not performed irradiation with low-intensity laser in upper trapezius muscle

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 to 40 years
• Male and female volunteers
• History of neck pain for a period of more than two months
• Score ranging from 15 to 24 on the Neck Disability Index
• Score ranging from three to seven points on an 11-point (range: 0 to 10) numerical rating scale (NRS) for perceived pain intensity

Exclusion Criteria

• history of neurological disorders
• neck surgery
• chronic neck pain resulting from a traumatic incident
• chronic musculoskeletal condition
• medical diagnosis of fibromyalgia; systemic disease
• connective tissue disorder
• having undergone physical therapy use of analgesic, muscle relaxant.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Simone Aparecida Penimpedo Calamita

UNKNOWN

Sponsor Role: collaborator

Fabiana Sarilho de Mendonça

UNKNOWN

Sponsor Role: collaborator

Daniela Aparecida Biasotto-Gonzalez

UNKNOWN

Sponsor Role: collaborator

Marco Antônio Fumagalli

UNKNOWN

Sponsor Role: collaborator

Paulo de Tarso Camilo de Camargo

UNKNOWN

Sponsor Role: collaborator

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Prof. Fabiano Politti, FT

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nove de Julho University

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

U9-2015

Identifier Type: -

Identifier Source: org_study_id