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

Federal University of the Valleys of Jequitinhonha and Mucuri

Status: Unknown

Conditions: Low Back Pain (LBP)

Treatments: Device: exercise + photobiomodulation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04287725

18022020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 2 patient groups, including a placebo group

exercise + active Photobiomodulation therapy (PBMT)

Experimental group

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).

Treatment:

Device: exercise + photobiomodulation therapy

exercise + placebo Photobiomodulation therapy (PBMT)

Placebo Comparator group

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).

Treatment:

Device: exercise + photobiomodulation therapy