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

NCT05487118 | Active Not Recruiting

• 1 other identifier: 5.289.714
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 2

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.

Conditions

Low Back Pain

Keywords

Photobiomodulation Therapy; LLLT; Motor Control Exercise

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (6)

• Pain intensity

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

• Disability

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

• Levels of prostaglandin E2 (PGE2)

  At the end of treatment (6 weeks after randomization)

• Medication intake

  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

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

Study Arms (2)

Placebo PBMT + MCE

PLACEBO COMPARATOR

Placebo photobiomodulation therapy (PBMT), with a dose of 0 J, will be applied before a protocol of motor control exercises (MCE).

Device: Placebo PBMT + MCE

Active PBMT + MCE

ACTIVE COMPARATOR

Active photobiomodulation therapy (PBMT), with a dose of 30 J, will be applied before a protocol of motor control exercises (MCE).

Device: Active PBMT + MCE

Interventions

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.

Placebo PBMT + MCE

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.

Active PBMT + MCE

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead
• University of Bergen: collaborator

Study Sites (2)

Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

Location

Laboratory of Phototherapy and Innovative Technologies in Health

São Paulo, Brazil

Location

Related Publications (1)

• de Oliveira MFD, Bjordal JM, Schardong J, Plentz RDM, Casalechi HL, Leal-Junior ECP, Tomazoni SS. Effects of photobiomodulation therapy associated with motor control exercise for chronic non-specific low back pain: protocol for a randomised placebo-controlled trial. BMJ Open Sport Exerc Med. 2024 Sep 26;10(3):e002199. doi: 10.1136/bmjsem-2024-002199. eCollection 2024.

  PMID: 39345834 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Shaiane Tomazoni, PhD

  University of Bergen

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: August 22, 2022
• Primary Completion: March 4, 2024
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available during five years after the study completion
• Access Criteria: All IPD that underlie results in a publication will be available on reasonable request.

Locations

BR (2)