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

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.

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).

Study Overview

• Status: Completed
• Conditions: Quality of Life; Low Back Pain; Kinesiophobia; Photobiomodulation; Strengthening Training
• Intervention / Treatment: Radiation: strengthening training and LED PBMT; Radiation: strengthening training and placebo PBMT

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Paraná
    • Londrina, Paraná, Brazil, 86.041-140
      • Universidade Norte do Paraná

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lumbar strengthening training combined with LED PBMT (TR+LED); Each participant will be submitted to a 8-wk lumbar strengthening training program and will receive the LED PBMT 30 minutes before each training session.	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).
Placebo Comparator: Lumbar strengthening training combined with placebo PBMT (TR+PLA); Each participant will be submitted to a 8-wk lumbar strengthening training program and will receive the placebo PBMT 30 minutes before each training session.	Radiation: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in postural balance	Postural balance will be assessed on a force platform at pre- and post-training	Baseline and after 8 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Pain Catastrophizing Scale (PCS)	PCS is a instrument used for measuring catastrophic thinking related to pain.	Baseline and after 8 weeks
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
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

Collaborators and Investigators

• Sponsor: Universidade Norte do Paraná

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Low back pain; Quality of life; kinesiophobia; Photobiomodulation; Strengthening training
• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Anxiety Disorders; Phobic Disorders; Back Pain; Low Back Pain; Kinesiophobia
• Other Study ID Numbers: Photobiomodulation project

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No