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Neck PainCervicalgiaNCT01849913

Laser Therapy on Neck Pain in Adolescents

A study testing Laser in people with Neck Pain, run by University of Nove de Julho at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 14 to 20 years
Conditions the study is for
Neck Pain
What is being tested?
Laser
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
1 siteBrazil
Study dates
Feb 2013to Jan 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site, 1 recruiting
  • University of Nove de Julho

    São Paulo, São Paulo, 01504-001

    Deise S Araujo, 55 11 981150052, deise.fisio@ymail.com

    Deise S Araujo

    Recruiting

Other trials in Brazil

About this study

Official title: Evaluation of the Effect of Low-level Laser Therapy on Neck Pain In Adolescents

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

Conditions
Neck Pain
Being tested
Laser, Placebo
Keywords
neck pain, hydrocortisone, stress, electromyography, adolescent, low-level laser therapy
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LaserOther

    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.

  • PlaceboOther

    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).

Study groups in NCT01849913
Study groupRoleWhat they receive
Group B & Group CExperimentalGroup B equal to low-level laser therapy dosis 5,9 j per point Group C equal to Placebo group
Receives: Other: Laser; Other: Placebo
Group A & Group CNo interventionGroup A equal to Control (no intervention) Group C equal to Placebo group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neck Disability Index - NDI

    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.

    Measured: One Year

Secondary outcomes (8)
  1. Surface electromyography (EMG) of neck extensors

    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.

    Measured: baseline and 6 weeks

  2. Analysis of salivary cortisol

    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.

    Measured: baseline and 6 weeks

  3. Neck extensor endurance test

    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.

    Measured: baseline and 90 days

  4. Evaluation of cervical range of motion

    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

    Measured: baseline and 90 days

  5. Postural evaluation

    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.

    Measured: baseline and 90 days

  6. Postural evaluation with photogrammetry using Postural Evaluation Software Program-SAPO

    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.

    Measured: baseline and 90 days

  7. International Physical Activity Questionnaire - IPAQ

    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

    Measured: baseline and 90 days

  8. Assessment of pain intensity using pressure algometry

    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.

    Measured: baseline and 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionSep 2013 (estimated)
  4. Study completionJan 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01849913
Sponsor's protocol ID
ABCDE-12345
Acronym
Cervicalgia
Status last verified
May 2013
First submitted
23 Apr 2013
Last updated
9 May 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Chow RT, Johnson MI, Lopes-Martins RA, Bjordal JM. Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials. Lancet. 2009 Dec 5;374(9705):1897-908. doi: 10.1016/S0140-6736(09)61522-1. Epub 2009 Nov 13.

    PubMed 19913903
  • Verhagen AP, Schellingerhout JM. Low-level laser therapy for neck pain. Lancet. 2010 Feb 27;375(9716):721; author reply 722. doi: 10.1016/S0140-6736(10)60296-6. No abstract available.

    PubMed 20189016
  • Gross AR, Aker PD, Goldsmith CH, Peloso P. Patient education for mechanical neck disorders. Cochrane Database Syst Rev. 2000;1998(2):CD000962. doi: 10.1002/14651858.CD000962.

    PubMed 10796403

Questions about this trial

What is this clinical trial studying?

A study testing Laser in people with Neck Pain, run by University of Nove de Julho at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Deise S Araujo (5511 981150052, deise.fisio@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neck Disability Index - NDI (time frame: One Year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01849913, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2013.

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