Laser Therapy on Neck Pain in Adolescents (Cervicalgia)
Primary Purpose
Neck Pain
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Laser
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring neck pain, hydrocortisone, stress, electromyography, adolescent, low-level laser therapy
Eligibility 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.
Sites / Locations
- University of Nove de JulhoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group B & Group C
Group A & Group C
Arm Description
Group B equal to low-level laser therapy dosis 5,9 j per point Group C equal to Placebo group
Group A equal to Control (no intervention) Group C equal to Placebo group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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
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.
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.
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
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.
Full Information
NCT ID
NCT01849913
First Posted
April 23, 2013
Last Updated
May 8, 2013
Sponsor
University of Nove de Julho
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01849913
Brief Title
Laser Therapy on Neck Pain in Adolescents
Acronym
Cervicalgia
Official Title
Evaluation of the Effect of Low-level Laser Therapy on Neck Pain In Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the proposed study is to investigate the effects of low-level laser therapy on neck pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
neck pain, hydrocortisone, stress, electromyography, adolescent, low-level laser therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group B & Group C
Arm Type
Experimental
Arm Description
Group B equal to low-level laser therapy dosis 5,9 j per point Group C equal to Placebo group
Arm Title
Group A & Group C
Arm Type
No Intervention
Arm Description
Group A equal to Control (no intervention) Group C equal to Placebo group
Intervention Type
Other
Intervention Name(s)
Laser
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
Neck Disability Index - NDI
Description
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.
Time Frame
One Year
Secondary Outcome Measure Information:
Title
Surface electromyography (EMG) of neck extensors
Description
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.
Time Frame
baseline and 6 weeks
Title
Analysis of salivary cortisol
Description
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.
Time Frame
baseline and 6 weeks
Title
Neck extensor endurance test
Description
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.
Time Frame
baseline and 90 days
Title
Evaluation of cervical range of motion
Description
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
Time Frame
baseline and 90 days
Title
Postural evaluation
Description
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.
Time Frame
baseline and 90 days
Title
Postural evaluation with photogrammetry using Postural Evaluation Software Program-SAPO
Description
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.
Time Frame
baseline and 90 days
Title
International Physical Activity Questionnaire - IPAQ
Description
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
Time Frame
baseline and 90 days
Title
Assessment of pain intensity using pressure algometry
Description
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.
Time Frame
baseline and 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deise S Araujo
Phone
5511 981150052
Email
deise.fisio@ymail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deise S Araujo
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nove de Julho
City
São Paulo
ZIP/Postal Code
01504-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deise S Araujo
Phone
55 11 981150052
Email
deise.fisio@ymail.com
First Name & Middle Initial & Last Name & Degree
Deise S Araujo
12. IPD Sharing Statement
Citations:
PubMed Identifier
19913903
Citation
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. Erratum In: Lancet. 2010 Mar 13;375(9718):894.
Results Reference
result
PubMed Identifier
20189016
Citation
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.
Results Reference
result
PubMed Identifier
10796403
Citation
Gross AR, Aker PD, Goldsmith CH, Peloso P. Patient education for mechanical neck disorders. Cochrane Database Syst Rev. 2000;(2):CD000962. doi: 10.1002/14651858.CD000962.
Results Reference
result
Learn more about this trial
Laser Therapy on Neck Pain in Adolescents
We'll reach out to this number within 24 hrs