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
Verified date | April 2019 |
Source | Universidade Norte do Paraná |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 54 |
Est. completion date | December 30, 2018 |
Est. primary completion date | November 15, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 55 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Rodrigo Antonio Carvalho ANDRAUS | Londrina | Paraná |
Lead Sponsor | Collaborator |
---|---|
Universidade Norte do Paraná | Universidade Estadual de Maringá |
Brazil,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cortisol levels | nmol/L | six weeks | |
Secondary | Visual Analogue Scale - pain intensity | 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 | |
Secondary | Aerobic performance | meters | six weeks | |
Secondary | Oswestry Disability Index - disability | 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 | |
Secondary | McGill Pain Questionnaire - Subjective pain measurement | 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 | |
Secondary | Fear-Avoidance Beliefs | 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 | |
Secondary | Functional test (Physical ability) | 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 | |
Secondary | creatine kinase levels | U/l | six weeks | |
Secondary | Schober test | To check the mobility of the lumbar spine | six weeks |
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