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

NCT ID: NCT04287725

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-02
• Study Completion Date: 2022-12-31

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.

Conditions

Low Back Pain (LBP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

exercise + photobiomodulation therapy

Intervention Type: DEVICE

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

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).

Group Type: PLACEBO_COMPARATOR

exercise + photobiomodulation therapy

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of the Valleys of Jequitinhonha and Mucuri

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Flávia Santos

Role: PRINCIPAL_INVESTIGATOR

Federal University of the Valleys of Jequitinhonha and Mucuri

Central Contacts

Murilo Oliveira

Role: CONTACT

muriloxavier@gmail.com

3532-1200 ext. 8972

Other Identifiers

18022020

Identifier Type: -

Identifier Source: org_study_id