Photobiomodulation Therapy on Inflammatory Mediators on Low Back Pain

NCT03859505 | Completed

• 1 other identifier: 2018/1361
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain (LBP) is ranked as one of the most prevalent health conditions. It is likely that some inflammatory mediators could be associated with pain and disability in these patients. Photobiomodulation therapy (PBMT) is a non-pharmacological therapy often used in patients with LBP that decrease release of inflammatory mediators and accelerate muscle repair in different muscle skeletal conditions, as mechanisms of action. The present research project aims to evaluate the effects of PBMT on systemic levels of inflammatory markers and levels of pain intensity in patients with chronic non-specific low back pain.

Conditions

Low Back Pain

Keywords

Low Back Pain; Photobiomodulation Therapy; PBMT; Low-Level Laser Therapy; LLLT

Outcome Measures

Primary Outcomes (1)

• Levels of prostaglandin E2 (PGE2)

  Inflammation will be measured by blood samples

  15 minutes after the treatment

Secondary Outcomes (3)

• Levels of tumor necrosis factor alpha (TNF-a)

  15 minutes after the treatment.

• Levels of interleukin-6 (IL-6)

  15 minutes after the treatment

• Pain Intensity

  15 minutes after the treatment.

Study Arms (2)

Placebo PBMT

PLACEBO COMPARATOR

Application of PBMT (Photobiomodulation Therapy) without any dose (0 Joule).

Device: Placebo PBMT

Active PBMT

ACTIVE COMPARATOR

Application of PBMT (Photobiomodulation Therapy) active.

Device: Active PBMT

Interventions

Placebo PBMT DEVICE

The PBMT treatments will be performed using the Multi Radiance Medical™ Super Pulsed Laser MR4™console (Solon, OH, USA), with the LS50 (emitter with an area of 20 cm2) and SE25 (emitter with an area of 4 cm2) cluster probes as emitters. Nine sites will be irradiated at patient's lumbar region: 3 central sites, using the SE25 (without any dose, 0 J); and 6 sites in the same direction, but laterally (both sides, 3 at a side), using the LS50 (without any dose, 0 J). Patients will be treated in a single session and they will receive a total dose of 0 J.

Placebo PBMT

Active PBMT DEVICE

The PBMT treatments will be performed using the Multi Radiance Medical™ Super Pulsed Laser MR4™ console (Solon, OH, USA), with the LS50 (emitter with an area of 20 cm2) and SE25 (emitter with an area of 4 cm2) cluster probes as emitters. Nine sites will be irradiated at patient's lumbar region: 3 central sites, using the SE25 (3000 Hz of frequency, 3 minutes of irradiation per site, 24.75 J per site, a totalizing 74.25 J irradiated from SE25); and 6 sites in the same direction, but laterally (both sides, 3 at a side), using the LS50 (1000 Hz of frequency, 3 minutes of irradiation per site, 24.30 J per site, a total of 145.80 J irradiated from LS50). Patients will be treated in a single session and will receive a total dose of 220.05 J.

Active PBMT

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 with 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;

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);
• serious cardiovascular and metabolic diseases;
• previous back surgery;
• pregnancy.
• severe skin diseases (eg. skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus);

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• University of Bergen: collaborator

Study Sites (1)

University of Bergen

Bergen, N-5018, Norway

Location

Related Publications (2)

• Tomazoni SS, Costa LOP, Joensen J, Stausholm MB, Naterstad IF, Ernberg M, Leal-Junior ECP, Bjordal JM. Photobiomodulation Therapy is Able to Modulate PGE2 Levels in Patients With Chronic Non-Specific Low Back Pain: A Randomized Placebo-Controlled Trial. Lasers Surg Med. 2021 Feb;53(2):236-244. doi: 10.1002/lsm.23255. Epub 2020 Apr 24.

  PMID: 32330315 DERIVED

• Tomazoni SS, Costa LOP, Joensen J, Stausholm MB, Naterstad IF, Leal-Junior ECP, Bjordal JM. Effects of photobiomodulation therapy on inflammatory mediators in patients with chronic non-specific low back pain: Protocol for a randomized placebo-controlled trial. Medicine (Baltimore). 2019 Apr;98(15):e15177. doi: 10.1097/MD.0000000000015177.

  PMID: 30985704 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The mode of intervention (active or placebo PBMT) will be coded by an independent researcher. The randomization schedule will contain only codes (not the actual intervention). The output from the PBMT device is exactly the same from either the active or the placebo interventions. These features will guarantee that participants, therapists and outcomes assessor will be blinded to the treatment arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral fellow and visiting researcher

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 1, 2019
• Study Start: March 18, 2019
• Primary Completion: March 29, 2019
• Study Completion: March 29, 2019
• Last Updated: April 1, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

NO (1)