Effects of Photobiomodulation and Deep Water Running Training in Subjects With Low Back Pain.
Condition: Low Back Pain; Hydrotherapy; Exertion; Excess
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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).

      Determination of cortisol and creatine kinase's blood markers At the beginning and at the end
      of the training period, blood samples will be collected for the determination of creatine
      kinase and cortisol levels. They will be stored in Eppendorf and then centrifuged at 3000rpm
      for 10 min. Serum will be stored at -20⁰C, while plasma will be discarded, and it wil be read
      with ck and cortisol analysis kit.

      Determination of mood, disability, pain intensity Questionnaires will be applied to monitor
      the state of beliefs and fears, disability and intensity of pain. The Fear avoidance beliefs
      questionnaire (FABQ) questionnaire, an instrument for assessing the beliefs and fears of
      individuals with low back pain and how this pain may affect their physical activities,
      FABQ-Phys subscale, and occupational subscale, subscale FABQ-Work. It consists of 16
      self-report items, which are divided into two subscales: the one that addresses the fears and
      beliefs of individuals in relation to work and in relation to physical activities. Each item
      is graded on a seven-point scale, ranging from 0 (completely disagree) to 6 (completely
      agree) (ABREU et al., 2008), and will be applied at the baseline and after the interventions
      are completed.

      The Oswestry Questionnaire presents 10 sections describing pain or limitations resulting from
      low back pain, The Oswestry Questionnaire presents 10 sections describing pain or limitations
      resulting from low back pain, will be applied before and after the intervention period. Each
      section presents six items, where the zero score indicates little or no pain and / or
      functional limitation, while score 5 is indicative of extreme pain and / or limitation
      (VIGATTO, ALEXANDRE and FILHO, 2007).

      To evaluate pain intensity, the EVA (COSTA, et al., 2008), which consists of a subjective
      evaluation of 0 (no pain) to 10 (lots of pain), will be applied in all sessions before and at
      the end of it. And for a more careful assessment of pain, McGill (PIMENTA and TEIXEIRA,
      1996), which is an instrument that provides quantitative information on pain and allows an
      association with sensorial, affective and evaluative qualities of the process which will be
      applied at the beginning and at the end of the interventions.

      TRAINING PROTOCOL The training sessions will be monitored based on the subjective perception
      of effort of the session (FOSTER, 1998), and heart rate. There will be two types of training:
      continuous and hight intensity interval. The sessions of the training group and group
      training + LED will be preceded by a warm-up of 15 minutes. Participants in the two training
      groups will undergo weekly training twice weekly in non-consecutive days during the four week
      period. A total of four continuous training sessions and four high intensity interval
      training sessions will be held. Continuous training will be 30 minutes at 70 - 80% HRmax, and
      interval training will be performed 30 minutes high intensity of laced running with fixation
      of an elastic tube in the floating vest, 30 seconds intense run in maximum effort and 30
      seconds of interval.

      LED Application The LED application will be performed in the GL and immediately after the GTL
      training sessions, and will be applied through the spot method with direct contact of the
      equipment over the irradiated site for 30 seconds. The application will be in the lumbar
      region, above the gluteal region, with an angle of 90 ° in relation to the cutaneous surface.
      A wavelength of 660 to 850 nm will be used with a frequency of 0 to 1500 Hz and energy
      irradiated of 0.9 J of each diode totaling 43.2J (48 diodes).
    

Intervention name(s): Training and LED group; Training group; LED group
Intervention type(s): Device; Device; Other
Intervention description(s): The LED application will be performed before GTL training sessions and will be applied through the spot method with direct contact of the equipment over the irradiated site for 30 seconds. The application will be in four points in the lumbar region, above the gluteal region, with an angle of 90 ° in relation to the cutaneous surface. A wavelength of 660 to 850nm will be used with a frequency of 0 to 1500 Hz and energy irradiated of 0.9 J of each diode totaling 43.2J (48 diodes).; The training sessions will be monitored based on the subjective perception of exertion of the session (PSESession) (FOSTER, 1998), and heart rate. There will be two types of training: continuous and interval training. The sessions of the training group (GT) and group training + LED (GL) will be preceded by a warm-up of 15 minutes. Participants in the two training groups will undergo weekly training twice weekly on non-consecutive days during four weeks. Continuous training will be 30 minutes at 70% to 80% of maximum heart rate, and interval training will be performed 30 minutes at 100% maximum heart rate of laced racing with fixation of an elastic tube in the floating vest, 30 seconds of intense running and 30 seconds interval. The LED off will be performed before training sessions.; This group will be applied through the spot method with direct contact of the equipment over the irradiated site for 30 seconds. The application will be in four points in the lumbar region, above the gluteal region, with an angle of 90 ° in relation to the cutaneous surface. A wavelength of 660 to 850nm will be used with a frequency of 0 to 1500 Hz and energy irradiated of 0.9 J of each diode totaling 43.2J (48 diodes).
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The first day, will be explanation of the project and signing of the Informed Consent Term. The participants will go to collect blood samples for analysis creatine kinase and cortisol levels. They will be submitted an anthropometric evaluation, psychometric questionnaires and perform functional tests, and perform of a continuous submaximal exertion test. All these procedures will be performed again at the end of the intervention, and the pain intensity scale will be applied in all meetings with participants (beginning and end of each session). 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 perform interval training sessions in addition to continuous training sessions. The second group will perform the same training model, and before the training sessions the LED will be applied. And the third group will only receive the LED application.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Low Back Pain; Photobiomodulation; Deep Water Running; Training; Running