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

NCT02498249 | Completed Phase 1 DMC

• 1 other identifier: U9-2015
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Low-Level Laser Therapy; trapezius muscle; neck pain

Outcome Measures

Primary Outcomes (1)

• Electromyographic activity

  The EMG signal will be recorded in the dominant upper trapezius muscle in patients with nonspecific neck pain, will be evaluated before and after treatment.

  1 Year

Secondary Outcomes (1)

• Numerical rating scale score for pain

  1 Year

Study Arms (2)

Experimental: low level laser therapy (LLLT)

EXPERIMENTAL

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

Device: low level laser therapy

Experimental: Placebo low level laser therapy (PLLLT)

PLACEBO COMPARATOR

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

Device: Placebo low level laser therapy

Interventions

low level laser therapy DEVICE

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

Experimental: low level laser therapy (LLLT)

Placebo low level laser therapy DEVICE

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

Experimental: Placebo low level laser therapy (PLLLT)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead
• Simone Aparecida Penimpedo Calamita: collaborator
• Fabiana Sarilho de Mendonça: collaborator
• Daniela Aparecida Biasotto-Gonzalez: collaborator
• Marco Antônio Fumagalli: collaborator
• Paulo de Tarso Camilo de Camargo: collaborator

Study Sites (1)

Nove de Julho University

São Paulo, São Paulo, 06454050, Brazil

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 15, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 15, 2015

Record last verified: 2015-07

Locations

BR (1)