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Completed

NCT Number: NCT02498249

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

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.

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Key information

Conditions

Neck Pain Treatment Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Nove de Julho University

São Paulo, 06454050, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Level Laser Therapy

Device

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

Placebo Low Level Laser Therapy

Device

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

Primary outcomes

  1. Electromyographic activity

    Time frame: 1 Year

    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.

Secondary outcomes

  1. Numerical rating scale score for pain

    Time frame: 1 Year

    A numerical rating scale for pain will be used to assess pain intensity in the NS-NP individuals. This is an 11-point scale ranging from 0 (absence of pain) to 10 (worst possible pain). The numerical rating scale was translated and cross-culturally adapted for the Brazilian population.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Collaborators

  • Daniela Aparecida Biasotto-Gonzalez
  • Fabiana Sarilho de Mendonça
  • Marco Antônio Fumagalli
  • Paulo de Tarso Camilo de Camargo
  • Simone Aparecida Penimpedo Calamita

Registry information

Official study title

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: a Randomized, Double-blinded, Sham-controlled, Crossover Study

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 15, 2015
Registry last updated
Jul 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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