Effects of Laser Therapy and Exercise in Participants With Chronic Low Back Pain

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain (LBP)
• Intervention / Treatment: Device: exercise + photobiomodulation therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Murilo Oliveira; Phone Number: 8972 3532-1200; Email: muriloxavier@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exercise + active Photobiomodulation therapy (PBMT); 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).	Device: exercise + photobiomodulation therapy; Treatment sessions will be provided twice a week for 6 weeks (totaling 12 sessions) with participants receiving either placebo or active PBMT + exercise protocol.
Placebo Comparator: exercise + placebo Photobiomodulation therapy (PBMT); 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).	Device: exercise + photobiomodulation therapy; Treatment sessions will be provided twice a week for 6 weeks (totaling 12 sessions) with participants receiving either placebo or active PBMT + exercise protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	Baseline; Immediately after the last intervention
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'.	Baseline; 3 months after the last intervention
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.	Baseline; Immediately after the last intervention
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.	Baseline; 3 months after the last intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	Baseline; 12 months after the last intervention
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.	Baseline; 12 months after the last intervention
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".	Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
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%).	Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
Changes of Mobility of the lumbar and sacral segments	Measured by the modified Schober test	Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
Changes of Strength of the trunk extensor muscle	Measured by the Sorensen Test	Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention

Collaborators and Investigators

• Sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri
• Investigators: Principal Investigator: Flávia Santos, Federal University of the Valleys of Jequitinhonha and Mucuri

Study record dates

Study Major Dates

• Study Start (Anticipated): June 2, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 8, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 18022020

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