Effects of Photobiomodulation and Deep Water Running Training in Subjects With Low Back Pain.

NCT03465228 | Completed

• 1 other identifier: 87013
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Low Back Pain; Hydrotherapy; Exertion; Excess

Keywords

Low Back Pain; Photobiomodulation; Deep Water Running; Training; Running

Outcome Measures

Primary Outcomes (1)

• Cortisol levels

  nmol/L

  six weeks

Secondary Outcomes (8)

• Visual Analogue Scale - pain intensity

  six weeks

• Aerobic performance

  six weeks

• Oswestry Disability Index - disability

  six weeks

• McGill Pain Questionnaire - Subjective pain measurement

  six weeks

• Fear-Avoidance Beliefs

  six weeks

Study Arms (3)

Training group

EXPERIMENTAL

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.

Device: Training group

Training and LED group

EXPERIMENTAL

This group will receive the photobiomodulation treatment and the same training model of training group.

Device: Training and LED group; Device: Training group

LED group

EXPERIMENTAL

This group will receive only the photobiomodulation treatment with 30 seconds of light emitting in four points of lumbar region.

Other: LED group

Interventions

Training and LED group DEVICE

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).

Training and LED group

Training group DEVICE

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.

Training and LED group; Training group

LED group OTHER

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).

LED group

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Norte do Paraná: lead
• Universidade Estadual de Maringá: collaborator

Study Sites (1)

Rodrigo Antonio Carvalho ANDRAUS

Londrina, Paraná, 8604140, Brazil

Location

Related Publications (8)

• 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.

  PMID: 9662690 BACKGROUND

• 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.

  PMID: 20335313 BACKGROUND

• 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.

  PMID: 19547850 BACKGROUND

• 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.

  PMID: 18327449 BACKGROUND

• 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.

  PMID: 17304141 BACKGROUND

• 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.

  PMID: 18923324 BACKGROUND

• Pimenta CA, Teixeiro MJ. [Proposal to adapt the McGill Pain Questionnaire into Portuguese]. Rev Esc Enferm USP. 1996 Dec;30(3):473-83. Portuguese.

  PMID: 9016160 BACKGROUND

• 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.

  PMID: 35246766 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniele MK Nardino, Specialist

  Universidade Norte do Paraná

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants will be not informed if the LED appliance will be on or off, and the outcomes will be numbers for identification.
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 14, 2018
• Study Start: November 15, 2017
• Primary Completion: November 15, 2018
• Study Completion: December 30, 2018
• Last Updated: April 3, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)