Effects of Lumbar Strengthening Training Plus Photobiomodulation on Non-specific Low-back Pain.

Quality of Life Clinical Trial

Official title:

Effects of Lumbar Strengthening Training Combined With Photobiomodulation Therapy on Functional and Psychological Aspects in Young and Older Adults With Chronic Non-specific Low Back Pain: a Randomized, Placebo-controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04887987
• Other study ID #: Photobiomodulation project
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: September 2023
• Source: Universidade Norte do Paraná
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present project aims to investigate the effects of lumbar strengthening training combined with photobiomodulation therapy (PBMT) on functional and psychological aspects in young and older adults with chronic non-specific low back pain. We hypothesized that lumbar strengthening training combined with PBMT should promote greater improvement on functional and psychological variables compared to strengthening training alone (placebo PBMT).

Description:

The purpose of this study will be to investigate the effects of lumbar strengthening training combined with photobiomodulation therapy (PBMT) therapy by light-emitting diode (LED) on functional and psychological aspects in young and older adults with chronic non-specific low back pain. Initially, all participants will be submitted for a 2-wk familiarization period with physical tests, and then randomized into two groups (N = 16/group): lumbar strengthening training combined with LED PBMT (TR+LED) and lumbar strengthening training combined with placebo PBMT (TR+PLA). Both groups will be submitted to a supervised 8-wk training program (3 x/week) involving a specific lumbar extension exercise on the Roman bench and four complementary exercises to improve core strength and spine stabilization. The groups will receive their respective PBMT (LED or placebo) 30 minutes before each training session, through a device containing 264 LEDs (132 LEDs of 660 nm and 132 LEDs of 850 nm), which will be placed on the lumbar region (between L1 and L5) with the participants lying in the prone position. The placebo LED will be applied with the device turned off. Participans will be blinded to PBM treatments. The following variables will be assessed at pre and post-training: anthropometric, body composition by bioimpedance, level of physical activity by International Physical Activity Questionnaire (IPAQ), maximal voluntary isometric contraction (MVIC) for lumbar extension exercise, short physical performance battery (SPPB), postural balance on a force platform, Schober test for lumbar spine flexion, Tampa Scale of kinesiophobia (TSK), Fear Avoidance Beliefs Questionnaire (FABQ), pain catastrophizing scale (PCS), quality of life by WHOQOL, oswestry disability index (ODI), Roland Morris disability questionnaire (RMDQ), McGILL pain questionnaire, and visual analogue scale (VAS). Shapiro-Wilk and Levene tests will be used to test the normality and homogeneity of the measurements, respectively. Two-way ANOVA (group x time) tests for repeated measures will be performed to assess changes over time and between groups for all dependent variables. Violation of sphericity will adjust using Greenhouse-Geisser correction. The Bonferroni post-hoc test will detect specific differences between groups. When appropriate, the percentage of change (∆%) will be reported according to the following equation: ∆% = [(pre-average post average) / pre-average mean] × 100. Values will be express as mean ± standard deviation. O significance level α will be 0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Men and women aged 18-80 years
• To be eutrophic (BMI: 25-27 kg/cm2)
• Self-report of recurrent (= 3 x/week) or continuous episodes of nonspecific low back pain for at least 3 months, comprising the lumbar region between L1-L5
• To be physiscally active according to the International Physical Activity Questionnaire (IPAQ)

Exclusion Criteria:

• To present a history of musculoskeletal disorders that could affect muscle function
• To make use of medicines that could affect muscle function.
• To present low back pain of specific etiology, such as: tumor, herniated disc, facet syndrome, canal stenosis, among others.
• To have used ergogenic supplements and anabolic steroids for at least six months before study
• To present severe skin diseases in the lumbar region, such as: erysipelas, eczema, dermatitis, psoriasis and urticaria
• To have restrictions for exercises practice considering Physical Activity Readiness Questionnaire (PAR-Q) responses.

Related Conditions & MeSH terms

• Back Pain
• Kinesiophobia
• Low Back Pain
• Photobiomodulation
• Quality of Life

Intervention

Radiation:
• strengthening training and LED PBMT
Participants will be submitted to a supervised 8-wk training program (3 d/week) involving a specific lumbar extension exercise on the Roman bench and four complementary exercises to improve core strength and spine stabilization. Participants will receive LED PBMT 30 minutes before each training session, through a device containing 264 LEDs, which will be placed on the lumbar region (between L1 and L5).
• strengthening training and placebo PBMT
Participants will be submitted to a supervised 8-wk training program (3 d/week) involving a specific lumbar extension exercise on the Roman bench and four complementary exercises to improve core strength and spine stabilization. Participants will receive placebo PBMT 30 minutes before each training session, through a off-line device (turned off) containing 264 LEDs, which will be placed on the lumbar region (between L1 and L5).

Locations

Country	Name	City	State
Brazil	Universidade Norte do Paraná	Londrina	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Norte do Paraná

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in postural balance	Postural balance will be assessed on a force platform at pre- and post-training	Baseline and after 8 weeks
Primary	Change in low back pain	Low back pain will be assessed with a visual analogue scale (VAS) at pre- and post-training	Baseline and after 8 weeks
Secondary	Tampa Scale of kinesiophobia (TSK)	The TSK is a 17-item self report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or injury.	Baseline and after 8 weeks
Secondary	Fear-Avoidance Beliefs Questionnaire (FABQ)	The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability.	Baseline and after 8 weeks
Secondary	Pain Catastrophizing Scale (PCS)	PCS is a instrument used for measuring catastrophic thinking related to pain.	Baseline and after 8 weeks
Secondary	Oswestry Disability Index (ODI)	ODI is a questionnaire used to assess the subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain.	Baseline and after 8 weeks
Secondary	Roland Morris Disability Questionnaire (RMDQ)	RMDQ questionnaire is designed to assess self-rated physical disability caused by low back pain	Baseline and after 8 weeks