NCT04287725 - Effects of Laser Therapy and Exercise in Participants With Chronic Low Back Pain | Crick

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

130

Conditions

Low Back Pain (LBP)

Interventions

exercise + photobiomodulation therapyDEVICE

Treatment sessions will be provided twice a week for 6 weeks (totaling 12 sessions) with participants receiving either placebo or active PBMT + exercise protocol.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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'.

Time frame: 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'.

Time frame: 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.

Time frame: 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.

Time frame: Baseline; 3 months after the last intervention

Secondary Outcomes

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'.

Central Contacts

Murilo Oliveira

CONTACT

3532-1200 muriloxavier@gmail.com