Low Back Pain Clinical Trial
Official title:
Effects of Photobiomodulation and Deep Water Running Training in Subjects With Low Back Pain: a Randomized Controlled Trial
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).
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).
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