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

July 10, 2015 updated by: Prof. Fabiano Politti, FT, University of Nove de Julho

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 06454050
        • Nove de Julho University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Device: low level laser therapy
Will be performed irradiation with low-intensity laser in upper trapezius muscle
Placebo Comparator: 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
Device: Placebo low level laser therapy
Will be not performed irradiation with low-intensity laser in upper trapezius muscle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 Year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nove de Julho

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Simone Aparecida Penimpedo Calamita
Fabiana Sarilho de Mendonça
Daniela Aparecida Biasotto-Gonzalez
Marco Antônio Fumagalli
Paulo de Tarso Camilo de Camargo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U9-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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