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

NCT04287725 | Unknown

• 1 other identifier: 18022020
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain (LBP)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Change Of Pain intensity at 12 months post-intervention

  Baseline; 12 months after the last intervention

• Change of Disability associated with low back pain at 12 months post-intervention

  Baseline; 12 months after the last intervention

• Changes os Mental health

  Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention

• Changes of Disability associated with low back pain

  Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention

• Changes of Mobility of the lumbar and sacral segments

  Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention

Study Arms (2)

exercise + active Photobiomodulation therapy (PBMT)

EXPERIMENTAL

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

exercise + placebo Photobiomodulation therapy (PBMT)

PLACEBO COMPARATOR

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

Interventions

exercise + photobiomodulation therapy 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 + active Photobiomodulation therapy (PBMT); exercise + placebo Photobiomodulation therapy (PBMT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Federal University of the Valleys of Jequitinhonha and Mucuri: lead

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise Therapy; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Laser Therapy; Phototherapy

Study Officials

• Flávia Santos

  Federal University of the Valleys of Jequitinhonha and Mucuri

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Murilo Oliveira

CONTACT

3532-1200; muriloxavier@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 27, 2020
• Study Start: June 2, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share