Clinical trial NCT04287725: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain (LBP)
Lead sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change Of Pain intensity at post-intervention
timeFrame: Baseline; Immediately after the last intervention
measure: Change Of Pain intensity at 3 months post-intervention
timeFrame: Baseline; 3 months after the last intervention
measure: Change of Disability associated with low back pain at post-intervention
timeFrame: Baseline; Immediately after the last intervention
measure: Change of Disability associated with low back pain at 3 months post-intervention
timeFrame: Baseline; 3 months after the last intervention
Secondary outcomes:
measure: Change Of Pain intensity at 12 months post-intervention
timeFrame: Baseline; 12 months after the last intervention
measure: Change of Disability associated with low back pain at 12 months post-intervention
timeFrame: Baseline; 12 months after the last intervention
measure: Changes os Mental health
timeFrame: Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
measure: Changes of Disability associated with low back pain
timeFrame: Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
measure: Changes of Mobility of the lumbar and sacral segments
timeFrame: Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
measure: Changes of Strength of the trunk extensor muscle
timeFrame: Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of the Valleys of Jequitinhonha and Mucuri
name: Flávia Santos
role: PRINCIPAL_INVESTIGATOR
References: