- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03465228
Effects of Photobiomodulation and Deep Water Running Training in Subjects With Low Back Pain.
Effects of Photobiomodulation and Deep Water Running Training in Subjects With Low Back Pain: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Paraná
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Londrina, Paraná, Brazil, 8604140
- Rodrigo Antonio Carvalho ANDRAUS
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- sedentary
- nonsmoker
- diabetic
- 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
Exclusion Criteria:
- fear of swimming pool
- minimum frequency of 90%
- Unable to finalize training protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Training group
This group will do the Deep Water Running, with intervals and continuous training twice a week, and before each session, will be applied the LED equipment.
The training will be thirty minutes and will be controlled by heart rate, 70% to 80% maximum heart rate in continuous training, and maximum heart rate in intervals training.
|
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.
|
EXPERIMENTAL: Training and LED group
This group will receive the photobiomodulation treatment and the same training model of training group.
|
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.
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).
|
EXPERIMENTAL: LED group
This group will receive only the photobiomodulation treatment with 30 seconds of light emitting in four points of lumbar region.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cortisol levels
Time Frame: six weeks
|
nmol/L
|
six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale - pain intensity
Time Frame: six weeks
|
The Visual Analogue Scale - VAS consists of assisting in the measurement of pain intensity in the patient, where 0 means total absence of pain and 10 the maximum level of pain that the patient can bear.
|
six weeks
|
Aerobic performance
Time Frame: six weeks
|
meters
|
six weeks
|
Oswestry Disability Index - disability
Time Frame: six weeks
|
The Oswestry Disability Index (ODI) is an index for to quantify disability for low back pain.
This questionnaire contains ten topics followed by 6 statements describing different potential scenarios in the patient's life.
Each question has a scale of 0-5 where the scores for all questions answered are summed, then multiplied to obtain the index (range 0 to 100).
Zero is equated with no disability and 100 is the maximum disability possible.
|
six weeks
|
McGill Pain Questionnaire - Subjective pain measurement
Time Frame: six weeks
|
McGill Pain Questionnaire is a scale of rating pain that describe the quality and intensity of pain that the pacient are experiencing.
These words or items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe.
|
six weeks
|
Fear-Avoidance Beliefs
Time Frame: six weeks
|
FABQ measures patients' fear of pain and his avoidance of physical activity because of their fear.
They are 16 items, with each item scored from 0-6 where higher scores on the FABQ are indicative of greater fear and avoidance beliefs.
|
six weeks
|
Functional test (Physical ability)
Time Frame: six weeks
|
Index by Sit-up test: this test consists in quantifying how many supports (hands and / or knees or, still, hands or forearms on knees), the individual uses to sit and lift from the ground.
Independent notes are assigned for each of the two acts - sit and stand up.
The maximum grade is 5 for each of the two acts, one point being lost for each support or even half a point for any perceptible imbalance.
|
six weeks
|
creatine kinase levels
Time Frame: six weeks
|
U/l
|
six weeks
|
Schober test
Time Frame: six weeks
|
To check the mobility of the lumbar spine
|
six weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniele MK Nardino, Specialist, Universidade Norte do Paraná
Publications and helpful links
General Publications
- Vigatto R, Alexandre NM, Correa Filho HR. Development of a Brazilian Portuguese version of the Oswestry Disability Index: cross-cultural adaptation, reliability, and validity. Spine (Phila Pa 1976). 2007 Feb 15;32(4):481-6. doi: 10.1097/01.brs.0000255075.11496.47.
- Abreu AM, Faria CD, Cardoso SM, Teixeira-Salmela LF. [The Brazilian version of the Fear Avoidance Beliefs Questionnaire]. Cad Saude Publica. 2008 Mar;24(3):615-23. doi: 10.1590/s0102-311x2008000300015. Portuguese.
- Costa LO, Maher CG, Latimer J, Ferreira PH, Ferreira ML, Pozzi GC, Freitas LM. Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best? Spine (Phila Pa 1976). 2008 Oct 15;33(22):2459-63. doi: 10.1097/BRS.0b013e3181849dbe.
- Foster C. Monitoring training in athletes with reference to overtraining syndrome. Med Sci Sports Exerc. 1998 Jul;30(7):1164-8. doi: 10.1097/00005768-199807000-00023.
- Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010 Jun 1;152(11):726-32. doi: 10.7326/0003-4819-152-11-201006010-00232. Epub 2010 Mar 24.
- Camargo VM, Martins Bdo C, Jardim C, Fernandes CJ, Hovnanian A, Souza R. Validation of a treadmill six-minute walk test protocol for the evaluation of patients with pulmonary arterial hypertension. J Bras Pneumol. 2009 May;35(5):423-30. doi: 10.1590/s1806-37132009000500006. English, Portuguese.
- Pimenta CA, Teixeiro MJ. [Proposal to adapt the McGill Pain Questionnaire into Portuguese]. Rev Esc Enferm USP. 1996 Dec;30(3):473-83. Portuguese.
- Nardin DMK, Stocco MR, Aguiar AF, Machado FA, de Oliveira RG, Andraus RAC. Effects of photobiomodulation and deep water running in patients with chronic non-specific low back pain: a randomized controlled trial. Lasers Med Sci. 2022 Jun;37(4):2135-2144. doi: 10.1007/s10103-021-03443-6. Epub 2022 Mar 4.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 87013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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