Laser Therapy on Neck Pain in Adolescents (Cervicalgia)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Nove de Julho
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Deise Sales de Araujo, University of Nove de Julho
ClinicalTrials.gov Identifier:
NCT01849913
First received: April 23, 2013
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

The aim of the proposed study is to investigate the effects of low-level laser therapy on neck pain.


Condition Intervention
Neck Pain
Other: Laser
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Low-level Laser Therapy on Neck Pain In Adolescents

Resource links provided by NLM:


Further study details as provided by University of Nove de Julho:

Primary Outcome Measures:
  • Neck Disability Index - NDI [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Recruitment will be determined from the results of the application of the NDI, which is composed of 10 questions addressing general activities and pain. The items are organized by the type of activity and involve six response options expressing progressive degrees of functional disability. Patients who had a score above 10% on the ndi questionnaire answers will be interviewed with the following questions: do you feel any pain often?, have had torticollis? how many times? and as to the time of pain. Those who answer that has intermittent pain for 3 months or more will be selected.


Secondary Outcome Measures:
  • Surface electromyography (EMG) of neck extensors [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    Muscle activity will be determined with the participant in a sitting position as well as during the neck muscle endurance test. The individuals will be submitted to bilateral EMG of the extensor muscles of the neck. The upper trapezius muscle will be used for the placement of the electrodes, which will be performed following the recommendations of the Surface EMG for Non-Invasive Assessment of Muscles (SENIAM). The participant will be instructed to execute three repetitions of each of the following for 15 seconds: rest, isometric contraction and isotonic contraction, with a one-minute rest interval between executions. The EMG signals will be captured using an eight-channel electromyograph, with a band frequency of 20 and 500 Hz, amplifier with a gain of 1000 Hz and > 100 dB rejection mode. The data will be processed using a 16-bit analog-digital converter, with a sampling frequency of 2000 Hz per channel. We hope the normalization of electrical activity in the musculature.

  • Analysis of salivary cortisol [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    For the study of the cortisol, two saliva samples will collected (1 before and 1 after treatment) at the participant's home at a time scheduled between 9 am and 9 pm with one hour of fasting and rinsing of the oral cavity with water. The saliva will be collected on swabs, consisting of a small roll of cotton on a plastic rod encased in a plastic tube. The swab will remain in the mouth for two minutes. The cotton will subsequently be placed in another tube for centrifugation and the sample will be stored at -20o C until analysis. All samples will be analyzed in duplicate through enzyme-linked immunosorbent assays (ELISA), using the supernatant of the centrifuged saliva. Cortisol level in the samples prior to treatment will be considered the control for each individual.

  • Neck extensor endurance test [ Time Frame: baseline and 90 days ] [ Designated as safety issue: No ]
    Endurance will be measured following the removal of the neck support, when the participant (positioned in ventral decubitus on a cot with the arms alongside the body) will be instructed to secure his/her head in a stable position. A goniometer will be attached with Velcro immediately above the uppermost point of the ear, where a gravity inclinometer will be used on the sagittal plane. An extendable metric tape with a pendulum at the end will be connected between the eyebrows and extended until just above the floor. Fatigue or pain will be the criterion for discontinuation. The test will also be discontinued if the participant: is unable to sustain his/her head off the cot to avoid touching the pendulum to the ground more than five times or for more than five seconds; he loses more than 5o of retraction of the cervical spine for more than five seconds. The target time will be 600 seconds, but participants capable of surpassing this limit will be encouraged to do so.

  • Evaluation of cervical range of motion [ Time Frame: baseline and 90 days ] [ Designated as safety issue: No ]
    Cervical range of motion will be measured for the following movements using a fleximeter: flexion, extension, right rotation, left rotation, right lateral flexion and left lateral flexion

  • Postural evaluation [ Time Frame: baseline and 90 days ] [ Designated as safety issue: No ]
    The points proposed by Kendall will be used for the postural evaluation on three planes: coronal-anterior, coronal-posterior and sagittal. The findings will be recorded on a standardized chart containing the identification of the participant, date of birth, school grade and abnormalities observed on each of the three planes.

  • Postural evaluation with photogrammetry using Postural Evaluation Software Program-SAPO [ Time Frame: baseline and 90 days ] [ Designated as safety issue: No ]
    The SAPO allows a two-dimensional quantification of the body. The evaluation will involve the taking of photographs in a previously assembled booth, following the recommendations of the Brazilian Review of Kinematics/Anthropometrics and Human Performance. The participant will be positioned perpendicular to the axis of a digital camera located at distances of 3 and 1.5 meters on a tripod adjusted to half the height of the participant. Photographs will be taken from the front, right side, left side and back views. The bone references that will serve as guides for the angular calculation will be marked with polystyrene balls on: glabellum, right and left tragus, chin, right and left acromion, manubrium, right and left lateral epicondyle, C7 spinal process, intersection between medial margin and spine of the right and left scapula, lower angle of right and left scapula, right and left posterosuperior iliac spine and right and left anterosuperior iliac spine.

  • International Physical Activity Questionnaire - IPAQ [ Time Frame: baseline and 90 days ] [ Designated as safety issue: No ]
    The IPAQ will be administered for the determination of physical activity in the previous week. The results will be classified based on the recommendations of the authors of the original questionnaire:sedentary; insufficiently active: insufficiently active A and insufficiently active B; Active: vigorous physical activity, moderate activity and any combined activity; Very active: vigorous physical activity and vigorous physical activity

  • Assessment of pain intensity using pressure algometry [ Time Frame: baseline and 90 days ] [ Designated as safety issue: No ]
    The digital algometer will then be applied to the upper trapezius muscle at the midpoint between the seventh cervical vertebra and the acromion, bilaterally, with an increase in pressure until the participant reports the sensation of pain. The procedure will be performed three times and the mean value will be considered in the analysis.A point is considered painful when pain is reported with the application of less than 4 kg/cm2 of pressure. The scores of different tender points will be totaled to quantify individual total pain intensity in kg/cm2. It is hoped that pain intensity in the treated group will be diminished.


Estimated Enrollment: 75
Study Start Date: February 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group B & Group C
Group B equal to low-level laser therapy dosis 5,9 j per point Group C equal to Placebo group
Other: Laser
The laser will be used 830 nm, 30 milliwatts twice a week: the initial dosage will be 5.9 J per point. The irradiation will be performed bilaterally on the belly of the trapezius muscle as well as 2 cm to the right and left and 2 and 4 cm below the belly of the muscle.
Other: Placebo
To provide the "blinding": the laser equipment has two identical application points furnished by the manufacturer - one active and the other a placebo (does not emit energy).
No Intervention: Group A & Group C
Group A equal to Control (no intervention) Group C equal to Placebo group

  Eligibility

Ages Eligible for Study:   14 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 14 to 20 years;
  • chronic neck pain;
  • no use of corticoids for at least 15 days prior to the onset of treatment;
  • agreement to participate; and
  • signed statement of informed consent by legal guardian.

Exclusion Criteria:

  • Currently undergoing physical therapy;
  • inability to participate in sessions;
  • specific diagnosis of infection, osteoporosis, polyarthritis or rheumatic disease; and
  • constant use of corticoids or analgesics.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01849913

Contacts
Contact: Deise S Araujo 5511 981150052 deise.fisio@ymail.com

Locations
Brazil
University of Nove de Julho Recruiting
São Paulo, Brazil, 01504-001
Contact: Deise S Araujo    55 11 981150052    deise.fisio@ymail.com   
Principal Investigator: Deise S Araujo         
Sponsors and Collaborators
University of Nove de Julho
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Deise S Araujo University of Nove de Julho
  More Information

Publications:
Responsible Party: Deise Sales de Araujo, Master, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT01849913     History of Changes
Other Study ID Numbers: ABCDE-12345
Study First Received: April 23, 2013
Last Updated: May 8, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Nove de Julho:
neck pain
hydrocortisone
stress
electromyography
adolescent
low-level laser therapy

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014