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

Primary Purpose

Strengthening Training, Photobiomodulation, Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
strengthening training and LED PBMT
strengthening training and placebo PBMT
Sponsored by
Universidade Norte do Paraná
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Strengthening Training focused on measuring Strengthening training, Photobiomodulation, Low back pain, Quality of life, kinesiophobia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidade Norte do Paraná

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lumbar strengthening training combined with LED PBMT (TR+LED)

Lumbar strengthening training combined with placebo PBMT (TR+PLA)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in postural balance
Postural balance will be assessed on a force platform at pre- and post-training
Change in low back pain
Low back pain will be assessed with a visual analogue scale (VAS) at pre- and post-training

Secondary Outcome Measures

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.
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.
Pain Catastrophizing Scale (PCS)
PCS is a instrument used for measuring catastrophic thinking related to pain.
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.
Roland Morris Disability Questionnaire (RMDQ)
RMDQ questionnaire is designed to assess self-rated physical disability caused by low back pain

Full Information

First Posted
May 13, 2021
Last Updated
September 8, 2023
Sponsor
Universidade Norte do Paraná
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1. Study Identification

Unique Protocol Identification Number
NCT04887987
Brief Title
Effects of Lumbar Strengthening Training Plus Photobiomodulation on Non-specific Low-back Pain.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Norte do Paraná

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strengthening Training, Photobiomodulation, Low Back Pain, Quality of Life, Kinesiophobia
Keywords
Strengthening training, Photobiomodulation, Low back pain, Quality of life, kinesiophobia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumbar strengthening training combined with LED PBMT (TR+LED)
Arm Type
Experimental
Arm Description
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.
Arm Title
Lumbar strengthening training combined with placebo PBMT (TR+PLA)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
strengthening training and LED PBMT
Intervention Description
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).
Intervention Type
Radiation
Intervention Name(s)
strengthening training and placebo PBMT
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in postural balance
Description
Postural balance will be assessed on a force platform at pre- and post-training
Time Frame
Baseline and after 8 weeks
Title
Change in low back pain
Description
Low back pain will be assessed with a visual analogue scale (VAS) at pre- and post-training
Time Frame
Baseline and after 8 weeks
Secondary Outcome Measure Information:
Title
Tampa Scale of kinesiophobia (TSK)
Description
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.
Time Frame
Baseline and after 8 weeks
Title
Fear-Avoidance Beliefs Questionnaire (FABQ)
Description
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.
Time Frame
Baseline and after 8 weeks
Title
Pain Catastrophizing Scale (PCS)
Description
PCS is a instrument used for measuring catastrophic thinking related to pain.
Time Frame
Baseline and after 8 weeks
Title
Oswestry Disability Index (ODI)
Description
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.
Time Frame
Baseline and after 8 weeks
Title
Roland Morris Disability Questionnaire (RMDQ)
Description
RMDQ questionnaire is designed to assess self-rated physical disability caused by low back pain
Time Frame
Baseline and after 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Universidade Norte do Paraná
City
Londrina
State/Province
Paraná
ZIP/Postal Code
86.041-140
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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