跳至主要内容
临床试验/NCT03465228
NCT03465228已完成不适用

Effects of Photobiomodulation and Deep Water Running Training in Subjects With Low Back Pain: a Randomized Controlled Trial

Universidade Norte do Paraná2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2017年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
试验地点
2
主要终点
Cortisol levels

研究概览

简要总结

Physical exercises proves to be an option to revert a vicious cycle and aggravation of the painful that chronic low back pain can provide, which can improve the mobility and stabilization of the spine, muscle strength, motor coordination and general aerobic conditioning. In addition, photobiomodulation using light emitting diodes (LEDs) has attracted attention for acute and chronic pain and wound healing, being used as a resource for prevention and recovery of lesions. Thus, the present study aims to analyze the efficacy of aerobic training systematized with Deep Water Running associated with photobiomodulation in individuals with chronic nonspecific low back pain. Individuals of both sexes, sedentary, who present chronic low back pain, aged between 30 and 55 years (middle-aged individuals) who meet the inclusion and exclusion criteria will be invited to participate. Anthropometric measurements, maximal stress test, functional tests, physiological measures and questionnaires concerning disability and pain, besides psychological ones, will be carried out. After the evaluations, the participants will be randomized into three experimental groups with 15 participants in each: the first group will be the training group that will hold interval training sessions in addition to continuous training sessions (GT). The second group will perform the same training model, and before the training sessions the LED will be applied (GTL). And the third group will only receive the LED application (GL).

详细描述

This study will be a randomized clinical trial, structured according to the Consort-Statement, with a standardization that includes methodological design, conduction, analysis and interpretation and evaluation of results. The participants will be individuals of both sexes, sedentary, who present chronic low back pain, aged between 30 and 55 years (middle-aged individuals), will be invited to participate. Participants will be informed of all experimental procedures of the study and will sign the Informed Consent Form and to answer the socio-demographic questionnaire. Participation in the study will be voluntary and free of any bonuses or liens; all participants will be free to withdraw their consent at any time without any loss. Prior to the tests, participants will perform prior clinical examinations with the cardiologist to have their cardiac fitness and release checked to carry out the pertinent evaluations of the study. The possible discomfort felt after the tests and training such as tiredness, muscular pain, perspiration will be similar to the senses during the practice of physical exercises. The procedures to be used in this research will follow the regulations required in Resolution 196/96 of the National Health Council on research involving human beings.

Evaluation protocol Body mass index and skin folds of triceps, subscapular, pectoral, abdominal, thigh mean, suprailiac and mean axillary for subsequent determination of fat percentage.

6-minute walk test-adapted The 6-minute walk test consists of a test that evaluates the distance a person can walk on a flat, rigid surface in six minutes and has as main goal the determination of exercise tolerance and oxygen saturation during a submaximal exercise . This test will be adapted to aquatic environment (CAMARGO et al., 2009).

Sit-up test The sit-up test, which consists of quantifying how many supports (hands and / or knees or, still, hands or forearms on knees), the individual uses to sit and lift from the floor. This method of evaluation allows us to analyze items such as flexibility of the lower limb joints, balance, motor coordination and the relation between muscular power and body weight, which can be characterized as minimum functional muscular fitness (ARAUJO, 1999).

Schober's Test To measure the range of motion of the lumbar spine, the Schober test will be performed, which consists of placing a tape measure from the lumbosacral joint, 10 cm above with the individual in a neutral position, and request the trunk flexion, where the increase of the distance between the marks will provide the estimate of the flexion amplitude of the lumbar spine (Schober, 1937).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The participants will be not informed if the LED appliance will be on or off, and the outcomes will be numbers for identification.

入排标准

年龄范围
30 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • sedentary
  • nonsmoker
  • hipertensive
  • asthmatic
  • cardiovascular disease
  • any restriction to the practice of physical exercise
  • severe spinal diseases
  • previous surgery on the spine
  • nerve root compression
  • infection or skin lesion at the site of the LED application
  • who has been under physiotherapy for chronic low back pain in the last six months

排除标准

  • fear of swimming pool
  • minimum frequency of 90%
  • Unable to finalize training protocol

结局指标

主要结局

Cortisol levels

时间窗: six weeks

nmol/L

次要结局

  • Aerobic performance(six weeks)
  • McGill Pain Questionnaire - Subjective pain measurement(six weeks)
  • Fear-Avoidance Beliefs(six weeks)
  • Functional test (Physical ability)(six weeks)
  • Schober test(six weeks)
  • creatine kinase levels(six weeks)
  • Visual Analogue Scale - pain intensity(six weeks)
  • Oswestry Disability Index - disability(six weeks)

研究者

发起方
Universidade Norte do Paraná
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rodrigo Antonio Carvalho Andraus

Doctor

Universidade Norte do Paraná

研究点 (2)

Loading locations...

相似试验