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Laser Therapy on Neck Pain in Adolescents (Cervicalgia)

2013년 5월 8일 업데이트: Deise Sales de Araujo, University of Nove de Julho

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.

연구 개요

상태

알려지지 않은

정황

연구 유형

중재적

등록 (예상)

75

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • São Paulo, 브라질, 01504-001
        • 모병
        • University of Nove de Julho
        • 연락하다:
        • 수석 연구원:
          • Deise S Araujo

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

14년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Group B & Group C
Group B equal to low-level laser therapy dosis 5,9 j per point Group C equal to Placebo group
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.
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).
간섭 없음: Group A & Group C
Group A equal to Control (no intervention) Group C equal to Placebo group

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Neck Disability Index - NDI
기간: One Year
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.
One Year

2차 결과 측정

결과 측정
측정값 설명
기간
Surface electromyography (EMG) of neck extensors
기간: baseline and 6 weeks
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.
baseline and 6 weeks
Analysis of salivary cortisol
기간: baseline and 6 weeks
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.
baseline and 6 weeks
Neck extensor endurance test
기간: baseline and 90 days
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.
baseline and 90 days
Evaluation of cervical range of motion
기간: baseline and 90 days
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
baseline and 90 days
Postural evaluation
기간: baseline and 90 days
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.
baseline and 90 days
Postural evaluation with photogrammetry using Postural Evaluation Software Program-SAPO
기간: baseline and 90 days
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.
baseline and 90 days
International Physical Activity Questionnaire - IPAQ
기간: baseline and 90 days
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
baseline and 90 days
Assessment of pain intensity using pressure algometry
기간: baseline and 90 days
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.
baseline and 90 days

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Deise S Araujo, University of Nove de Julho

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2013년 2월 1일

기본 완료 (예상)

2013년 9월 1일

연구 완료 (예상)

2014년 1월 1일

연구 등록 날짜

최초 제출

2013년 4월 23일

QC 기준을 충족하는 최초 제출

2013년 5월 8일

처음 게시됨 (추정)

2013년 5월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 5월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 5월 8일

마지막으로 확인됨

2013년 5월 1일

추가 정보

이 연구와 관련된 용어

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Laser에 대한 임상 시험

3
구독하다