PBMT Associated With MCE for Chronic Non- Specific Low Back Pain

Low Back Pain Clinical Trial

Official title:

Effects of Photobiomodulation Therapy (LASER) Associated With Motor Control Exercises for Chronic Non-specific Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05487118
• Other study ID #: 5.289.714
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2022
• Est. completion date: December 2024

Study information

• Verified date: August 2022
• Source: University of Nove de Julho
• Contact: Ernesto Leal Junior, PhD
• Phone: +551133859134
• Email: ernesto.leal.junior[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Non-specific low back pain (LBP) is a very prevalent health condition and is highly associated with disability worldwide. There is evidence that patients with non-specific LBP may have impairments in the control of postural muscles. In this way, motor control exercises (MCE) may be an interesting alternative in the treatment of patients with non-specific LBP. In addition, the association of MCE and photobiomodulation therapy (PBMT) may potentiate its benefits, since PBMT has ergogenic effects. Therefore, the aim of this study is to evaluate the ergogenic effects of PBMT, using low-level laser therapy, when associated with MCE in patients with chronic non-specific low back pain.

Description:

This is a randomized, triple-blind (patients, therapists, outcome assessors), placebo-controlled trial, with voluntary patients with chronic non-specific low back pain. One hundred and forty-eight patients will be randomly allocated to two treatment groups: Placebo PBMT associated with MCE or Active PBMT associated with MCE. Treatment will be performed twice a week (on non-consecutive days), for 6 weeks, yielding 12 treatment sessions. Placebo PBMT or Active PBMT will be applied before the MCE protocol.

The clinical outcomes will be obtained at the end of treatment (6 weeks), one month after the end of treatment, 3, 6 and 12 months after randomization. The biochemical outcome will be obtained only after the end of treatment. The remaining outcomes will be obtained after the end of treatment, one month after the end of treatment, 3, 6 and 12 months after randomization.

The data will be collected by a blinded assessor. The statistical analysis will follow the intention-to-treat principles and the between-group differences will be calculated using two-way repeated measures ANOVA.

The project was also approved by the Research Ethics Committee from Universidade Nove de Julho, under the number 5.289.714.

Board Affiliation: Comissão Nacional de Ética em Pesquisa (CONEP) Phone: +55113385-9010 - Email: comitedeetica@uninove.br Address: Vergueiro nº 235/249. Liberdade, Sao Paulo, Sao Paulo, Brazil

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients seeking care for chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 month);

• with a pain intensity of at least 3 points measured by a 0-10 points pain numerical rating scale;

• aged between 18 and 65 years;

• able to read Portuguese.

Exclusion Criteria:

• evidence of nerve root compromise (i.e. one or more of motor, reflex or sensation deficit);

• serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases);

• patients with severe skin diseases (eg, skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus);

• decompensated severe cardiovascular and metabolic diseases;

• previous back surgery;

• patients with cancer;

• body mass index (BMI) = 30.

• pregnancy.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• Placebo PBMT + MCE
Placebo PBMT will be irradiated at 4 sites in the lumbar region and 6 sites in the patient's abdominal region, without any emission of therapeutic dose. After, the patient will be submitted to a MCE protocol consisting on stabilization exercises and isometric abdominal training. The treatment will be performed twice a week (on non-consecutive days), for 6 weeks, yielding 12 treatment sessions.
• Active PBMT + MCE
Active PBMT will be irradiated at 4 sites in the lumbar region and 6 sites in the patient's abdominal region, with a dose of 30 J per site. After, the patient will be submitted to a MCE protocol consisting on stabilization exercises and isometric abdominal training. The treatment will be performed twice a week (on non-consecutive days), for 6 weeks, yielding 12 treatment sessions.

Locations

Country	Name	City	State
Brazil	Santa Casa de Misericórdia de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Laboratory of Phototherapy and Innovative Technologies in Health	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Nove de Julho	University of Bergen

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Pain intensity will be measured by Pain Numerical Rating Scale that 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'. Higher scores mean worse outcome.	At the end of treatment (6 weeks after randomization)
Primary	Disability	Disability will be measured by the 24-item Roland Morris Disability Questionnaire. The questionnaire consists of 24 items that patient has to answer 'yes' or 'no'. The minimum value is 0 and the maximum value is 24. Higher scores mean worse outcome.	At the end of treatment (6 weeks after randomization)
Secondary	Pain intensity	Pain intensity will be measured by Pain Numerical Rating Scale that 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'. Higher scores mean worse outcome.	1 month after the end of the treatment, 3, 6 and 12 months after randomization
Secondary	Disability	Disability will be measured by the 24-item Roland Morris Disability Questionnaire. The questionnaire consists of 24 items that patient has to answer 'yes' or 'no'. The minimum value is 0 and the maximum value is 24. Higher scores mean worse outcome.	1 month after the end of the treatment, 3, 6 and 12 months after randomization
Secondary	Levels of prostaglandin E2 (PGE2)	Levels of PGE2 will be measured by blood samples	At the end of treatment (6 weeks after randomization)
Secondary	Medication intake	The medication intake will be measured from self-report	At the end of treatment (6 weeks after randomization), 1 month after the end of treatment, 3, 6 and 12 months after randomization
Secondary	Co-interventions	Co-interventions will be measured from self-report	At the end of treatment (6 weeks after randomization),1 month after the end of treatment, 3, 6 and 12 months after randomization
Secondary	Adverse events	Adverse events will be measured from self-report	At the end of treatment (6 weeks after randomization), 1 month after the end of treatment, 3, 6 and 12 months after randomization