Clinical trial NCT05487118: PBMT Associated With MCE for Chronic Non- Specific Low Back Pain
Official title: Effects of Photobiomodulation Therapy (LASER) Associated With Motor Control Exercises for Chronic Non-specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Photobiomodulation Therapy
LLLT
Motor Control Exercise
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2022-08-04
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity
timeFrame: At the end of treatment (6 weeks after randomization)
measure: Disability
timeFrame: At the end of treatment (6 weeks after randomization)
Secondary outcomes:
measure: Pain intensity
timeFrame: 1 month after the end of the treatment, 3, 6 and 12 months after randomization
measure: Disability
timeFrame: 1 month after the end of the treatment, 3, 6 and 12 months after randomization
measure: Levels of prostaglandin E2 (PGE2)
timeFrame: At the end of treatment (6 weeks after randomization)
measure: Medication intake
timeFrame: At the end of treatment (6 weeks after randomization), 1 month after the end of treatment, 3, 6 and 12 months after randomization
measure: Co-interventions
timeFrame: At the end of treatment (6 weeks after randomization),1 month after the end of treatment, 3, 6 and 12 months after randomization
measure: Adverse events
timeFrame: At the end of treatment (6 weeks after randomization), 1 month after the end of treatment, 3, 6 and 12 months after randomization
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericórdia de Porto Alegre
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: Laboratory of Phototherapy and Innovative Technologies in Health
Study officials:
affiliation: University of Bergen
name: Shaiane Tomazoni, PhD
role: PRINCIPAL_INVESTIGATOR
References: