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NCT Number: NCT05487118

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil

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About this study

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: [email protected] Address: Vergueiro nº 235/249. Liberdade, Sao Paulo, Sao Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo PBMT + MCE

Device

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

Device

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.

Primary outcomes

  1. Pain intensity

    Time frame: At the end of treatment (6 weeks after randomization)

    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.

  2. Disability

    Time frame: At the end of treatment (6 weeks after randomization)

    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.

Secondary outcomes

  1. Pain intensity

    Time frame: 1 month after the end of the treatment, 3, 6 and 12 months after randomization

    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.

  2. Disability

    Time frame: 1 month after the end of the treatment, 3, 6 and 12 months after randomization

    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.

  3. Levels of prostaglandin E2 (PGE2)

    Time frame: At the end of treatment (6 weeks after randomization)

    Levels of PGE2 will be measured by blood samples

  4. Medication intake

    Time frame: At the end of treatment (6 weeks after randomization), 1 month after the end of treatment, 3, 6 and 12 months after randomization

    The medication intake will be measured from self-report

  5. Co-interventions

    Time frame: At the end of treatment (6 weeks after randomization),1 month after the end of treatment, 3, 6 and 12 months after randomization

    Co-interventions will be measured from self-report

  6. Adverse events

    Time frame: At the end of treatment (6 weeks after randomization), 1 month after the end of treatment, 3, 6 and 12 months after randomization

    Adverse events will be measured from self-report

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Collaborators

  • University of Bergen

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Aug 4, 2022
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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