Back to resultsEffects of Laser Therapy and Exercise in Participants With Chronic Low Back Pain
Primary Purpose
Low Back Pain (LBP)
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
exercise + photobiomodulation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain (LBP)
Eligibility Criteria
Inclusion Criteria:
- Patients with non-specific chronic LBP, defined as pain or discomfort between the costal margins and inferior gluteal folds with or without referred pain to the lower limbs;
- Persistent LBP for at least 3 months;
- Low back pain of intensity reported 3 or higher by the Visual Analogue Scale (VAS), at least once in the previous 7 days;
- Aged between 18 and 65 years;
- Both genders.
Exclusion Criteria:
- Patients with severe skin diseases (eg, skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus);
- Participants with known or suspected serious spinal pathology (e.g., fractures, tumors, inflammatory, rheumatologic disorders, or infective diseases of the spine);
- Nerve root compromise;
- History of previous spinal surgery (even in a segment other than the lumbar spine) or scheduled surgery;
- Pain due to or associated with pregnancy or structural deformity (for example, scoliosis);
- Pregnancy;
- Comorbid health conditions that could prevent active participation in the exercise programs such as high blood pressure, pregnancy, or cardio-respiratory illnesses;
- Having answered "yes" to any of the questions in the Physical Activity Readiness Questionnaire (PAR-Q);
- Be treated with PBMT;
- Being under physiotherapeutic treatment or perform physical exercise;
- Who are using NSAID or start it during the trial;
- Who have inability to tolerate the proposed experimental procedures (such as tests of mobility and strength of the lumbar muscles).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
exercise + active Photobiomodulation therapy (PBMT)
exercise + placebo Photobiomodulation therapy (PBMT)
Arm Description
Exercise protocol: The program will consist of individual sessions of progressive and submaximal exercises with aerobic training on a treadmill and spine strengthening exercise. Photobiomodulation therapy: will be performed using the active super pulsed laser (904nm).
Exercise protocol: The program will consist of individual sessions of progressive and submaximal exercises with aerobic training on a treadmill and spine strengthening exercise. Photobiomodulation therapy: will be performed using the placebo super pulsed laser (904nm).
Outcomes
Primary Outcome Measures
Change Of Pain intensity at post-intervention
Measured by the Visual Analogue Scale (VAS). The VAS evaluates pain intensity levels perceived by the patient on an 11-point scale ranging from 0 to 10, with 0 being 'no pain' and 10 'the worst possible pain'.
Change Of Pain intensity at 3 months post-intervention
Measured by the Visual Analogue Scale (VAS). The VAS evaluates pain intensity levels perceived by the patient on an 11-point scale ranging from 0 to 10, with 0 being 'no pain' and 10 'the worst possible pain'.
Change of Disability associated with low back pain at post-intervention
Measured by the Roland-Morris Disability Questionnaire. The questionnaire consists of 24 items that describe situations that patients may have difficulty performing on a daily basis due to LBP. The greater the number of affirmative answers is, the higher the level of functional disability associated with LBP.
Change of Disability associated with low back pain at 3 months post-intervention
Measured by the Roland-Morris Disability Questionnaire. The questionnaire consists of 24 items that describe situations that patients may have difficulty performing on a daily basis due to LBP. The greater the number of affirmative answers is, the higher the level of functional disability associated with LBP.
Secondary Outcome Measures
Change Of Pain intensity at 12 months post-intervention
Measured by the Visual Analogue Scale (VAS). The VAS evaluates pain intensity levels perceived by the patient on an 11-point scale ranging from 0 to 10, with 0 being 'no pain' and 10 'the worst possible pain'.
Change of Disability associated with low back pain at 12 months post-intervention
Measured by the Roland-Morris Disability Questionnaire. The questionnaire consists of 24 items that describe situations that patients may have difficulty performing on a daily basis due to LBP. The greater the number of affirmative answers is, the higher the level of functional disability associated with LBP.
Changes os Mental health
Measured by the reduced version of the Anxiety, Depression and Stress Scale-21. It is a self-report instrument composed of three subscales with seven items each, to assess depression, anxiety and stress in the previous week. The variations in scores correspond to symptom levels, which vary between "normal" and "very severe".
Changes of Disability associated with low back pain
Measured by the Oswestry Low Back Pain Disability Questionnaire. The scale consists of 10 questions with six alternatives, the value of which ranges from 0 to 5. It is classified into: minimum disability (0 - 20%), moderate disability (21- 40%), severe disability (41 - 60%) , a patient who is disabled (61 - 80%), and an individual restricted to bed (81 - 100%).
Changes of Mobility of the lumbar and sacral segments
Measured by the modified Schober test
Changes of Strength of the trunk extensor muscle
Measured by the Sorensen Test
Full Information
NCT ID
NCT04287725
First Posted
February 18, 2020
Last Updated
March 3, 2021
Sponsor
Federal University of the Valleys of Jequitinhonha and Mucuri
1. Study Identification
Unique Protocol Identification Number
NCT04287725
Brief Title
Effects of Laser Therapy and Exercise in Participants With Chronic Low Back Pain
Official Title
Additional Effects Of The Association Of The Photobiomodulation Therapy (904 Nm) With Exercise In Participants With Chronic Non-Specific Low Back Pain In The Long Term
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 2, 2021 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal University of the Valleys of Jequitinhonha and Mucuri
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 objective of this clinical trial is to evaluate the additional effects of Laser Therapy in participants with chronic non-specific low back pain in the short and long term.
Detailed Description
The objective of this clinical trial is to evaluate the additional effects of Photobiomodulation Therapy in participants with chronic non-specifc low back pain in the short and long term.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain (LBP)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
exercise + active Photobiomodulation therapy (PBMT)
Arm Type
Experimental
Arm Description
Exercise protocol: The program will consist of individual sessions of progressive and submaximal exercises with aerobic training on a treadmill and spine strengthening exercise.
Photobiomodulation therapy: will be performed using the active super pulsed laser (904nm).
Arm Title
exercise + placebo Photobiomodulation therapy (PBMT)
Arm Type
Placebo Comparator
Arm Description
Exercise protocol: The program will consist of individual sessions of progressive and submaximal exercises with aerobic training on a treadmill and spine strengthening exercise.
Photobiomodulation therapy: will be performed using the placebo super pulsed laser (904nm).
Intervention Type
Device
Intervention Name(s)
exercise + photobiomodulation therapy
Intervention Description
Treatment sessions will be provided twice a week for 6 weeks (totaling 12 sessions) with participants receiving either placebo or active PBMT + exercise protocol.
Primary Outcome Measure Information:
Title
Change Of Pain intensity at post-intervention
Description
Measured by the Visual Analogue Scale (VAS). The VAS evaluates pain intensity levels perceived by the patient on an 11-point scale ranging from 0 to 10, with 0 being 'no pain' and 10 'the worst possible pain'.
Time Frame
Baseline; Immediately after the last intervention
Title
Change Of Pain intensity at 3 months post-intervention
Description
Measured by the Visual Analogue Scale (VAS). The VAS evaluates pain intensity levels perceived by the patient on an 11-point scale ranging from 0 to 10, with 0 being 'no pain' and 10 'the worst possible pain'.
Time Frame
Baseline; 3 months after the last intervention
Title
Change of Disability associated with low back pain at post-intervention
Description
Measured by the Roland-Morris Disability Questionnaire. The questionnaire consists of 24 items that describe situations that patients may have difficulty performing on a daily basis due to LBP. The greater the number of affirmative answers is, the higher the level of functional disability associated with LBP.
Time Frame
Baseline; Immediately after the last intervention
Title
Change of Disability associated with low back pain at 3 months post-intervention
Description
Measured by the Roland-Morris Disability Questionnaire. The questionnaire consists of 24 items that describe situations that patients may have difficulty performing on a daily basis due to LBP. The greater the number of affirmative answers is, the higher the level of functional disability associated with LBP.
Time Frame
Baseline; 3 months after the last intervention
Secondary Outcome Measure Information:
Title
Change Of Pain intensity at 12 months post-intervention
Description
Measured by the Visual Analogue Scale (VAS). The VAS evaluates pain intensity levels perceived by the patient on an 11-point scale ranging from 0 to 10, with 0 being 'no pain' and 10 'the worst possible pain'.
Time Frame
Baseline; 12 months after the last intervention
Title
Change of Disability associated with low back pain at 12 months post-intervention
Description
Measured by the Roland-Morris Disability Questionnaire. The questionnaire consists of 24 items that describe situations that patients may have difficulty performing on a daily basis due to LBP. The greater the number of affirmative answers is, the higher the level of functional disability associated with LBP.
Time Frame
Baseline; 12 months after the last intervention
Title
Changes os Mental health
Description
Measured by the reduced version of the Anxiety, Depression and Stress Scale-21. It is a self-report instrument composed of three subscales with seven items each, to assess depression, anxiety and stress in the previous week. The variations in scores correspond to symptom levels, which vary between "normal" and "very severe".
Time Frame
Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
Title
Changes of Disability associated with low back pain
Description
Measured by the Oswestry Low Back Pain Disability Questionnaire. The scale consists of 10 questions with six alternatives, the value of which ranges from 0 to 5. It is classified into: minimum disability (0 - 20%), moderate disability (21- 40%), severe disability (41 - 60%) , a patient who is disabled (61 - 80%), and an individual restricted to bed (81 - 100%).
Time Frame
Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
Title
Changes of Mobility of the lumbar and sacral segments
Description
Measured by the modified Schober test
Time Frame
Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
Title
Changes of Strength of the trunk extensor muscle
Description
Measured by the Sorensen Test
Time Frame
Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with non-specific chronic LBP, defined as pain or discomfort between the costal margins and inferior gluteal folds with or without referred pain to the lower limbs;
Persistent LBP for at least 3 months;
Low back pain of intensity reported 3 or higher by the Visual Analogue Scale (VAS), at least once in the previous 7 days;
Aged between 18 and 65 years;
Both genders.
Exclusion Criteria:
Patients with severe skin diseases (eg, skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus);
Participants with known or suspected serious spinal pathology (e.g., fractures, tumors, inflammatory, rheumatologic disorders, or infective diseases of the spine);
Nerve root compromise;
History of previous spinal surgery (even in a segment other than the lumbar spine) or scheduled surgery;
Pain due to or associated with pregnancy or structural deformity (for example, scoliosis);
Pregnancy;
Comorbid health conditions that could prevent active participation in the exercise programs such as high blood pressure, pregnancy, or cardio-respiratory illnesses;
Having answered "yes" to any of the questions in the Physical Activity Readiness Questionnaire (PAR-Q);
Be treated with PBMT;
Being under physiotherapeutic treatment or perform physical exercise;
Who are using NSAID or start it during the trial;
Who have inability to tolerate the proposed experimental procedures (such as tests of mobility and strength of the lumbar muscles).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Murilo Oliveira
Phone
3532-1200
Ext
8972
Email
muriloxavier@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flávia Santos
Organizational Affiliation
Federal University of the Valleys of Jequitinhonha and Mucuri
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Laser Therapy and Exercise in Participants With Chronic Low Back Pain
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