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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

Primary Purpose

Neck Pain Treatment

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
low level laser therapy
Placebo low level laser therapy
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain Treatment focused on measuring Low-Level Laser Therapy, trapezius muscle, neck pain

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nove de Julho University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: low level laser therapy (LLLT)

Experimental: Placebo low level laser therapy (PLLLT)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Numerical rating scale score for pain
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.

Full Information

First Posted
July 6, 2015
Last Updated
July 10, 2015
Sponsor
University of Nove de Julho
Collaborators
Simone Aparecida Penimpedo Calamita, Fabiana Sarilho de Mendonça, Daniela Aparecida Biasotto-Gonzalez, Marco Antônio Fumagalli, Paulo de Tarso Camilo de Camargo
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1. Study Identification

Unique Protocol Identification Number
NCT02498249
Brief 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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
Collaborators
Simone Aparecida Penimpedo Calamita, Fabiana Sarilho de Mendonça, Daniela Aparecida Biasotto-Gonzalez, Marco Antônio Fumagalli, Paulo de Tarso Camilo de Camargo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain Treatment
Keywords
Low-Level Laser Therapy, trapezius muscle, neck pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: low level laser therapy (LLLT)
Arm Type
Experimental
Arm Description
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
Arm Title
Experimental: Placebo low level laser therapy (PLLLT)
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
low level laser therapy
Intervention Description
Will be performed irradiation with low-intensity laser in upper trapezius muscle
Intervention Type
Device
Intervention Name(s)
Placebo low level laser therapy
Intervention Description
Will be not performed irradiation with low-intensity laser in upper trapezius muscle
Primary Outcome Measure Information:
Title
Electromyographic activity
Description
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.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Numerical rating scale score for pain
Description
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.
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Nove de Julho University
City
São Paulo
ZIP/Postal Code
06454050
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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