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

Low Back Pain (LBP) Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04287725
• Other study ID #: 18022020
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2021
• Source: Federal University of the Valleys of Jequitinhonha and Mucuri
• Contact: Murilo Oliveira
• Phone: 3532-1200
• Email: muriloxavier[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain (LBP)

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of the Valleys of Jequitinhonha and Mucuri

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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'.	Baseline; 12 months after the last intervention
Secondary	Change of Disability associated with low back pain at 12 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; 12 months after the last intervention
Secondary	Changes os Mental health	Measured by the reduced version of the Anxiety, Depression and Stress Scale-21. It is a self-report instrument composed of three subscales with seven items each, to assess depression, anxiety and stress in the previous week. The variations in scores correspond to symptom levels, which vary between "normal" and "very severe".	Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
Secondary	Changes of Disability associated with low back pain	Measured by the Oswestry Low Back Pain Disability Questionnaire. The scale consists of 10 questions with six alternatives, the value of which ranges from 0 to 5. It is classified into: minimum disability (0 - 20%), moderate disability (21- 40%), severe disability (41 - 60%) , a patient who is disabled (61 - 80%), and an individual restricted to bed (81 - 100%).	Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
Secondary	Changes of Mobility of the lumbar and sacral segments	Measured by the modified Schober test	Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention
Secondary	Changes of Strength of the trunk extensor muscle	Measured by the Sorensen Test	Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention