Photobiomodulation Therapy on Inflammatory Mediators on Low Back Pain

NCT ID: NCT03859505

Last Updated: 2019-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-18
• Study Completion Date: 2019-03-29

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.

Detailed Description

This is a randomized, triple-blinded (therapist, assessor and patient), placebo-controlled trial, with voluntary patients with non-specific chronic low back pain.

Eighteen patients will be randomly allocated to two treatment groups: Placebo or PBMT and one single session of treatment will be provided.

The data will be collected by a blinded assessor and the outcomes of interest it will be levels of inflammatory markers and pain intensity and it will be collected at baseline and 15 minutes after the single session of treatment.

The statistical analysis will follow the intention-to-treat principles. The findings will be tested for their normality using the Shapiro-Wilk test. Parametric data will be expressed as mean and standard deviation and non-parametric data as median and respective upper and lower limits. Parametric data will be analyzed by two-way repeated measures analysis of variance (ANOVA; time versus experimental group) with post-hoc Bonferroni correction. Non-parametric data will be analyzed using the Friedman test and, secondarily, the Wilcoxon signed-rank test.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo PBMT

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

Group Type: PLACEBO_COMPARATOR

Placebo PBMT

Intervention Type: 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.

Active PBMT

Application of PBMT (Photobiomodulation Therapy) active.

Group Type: ACTIVE_COMPARATOR

Active PBMT

Intervention Type: 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.

Interventions

Placebo PBMT

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.

Intervention Type: DEVICE

Active PBMT

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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;

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);
• 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);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: collaborator

Universidade Cidade de Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Shaiane da Silva Tomazoni

Postdoctoral fellow and visiting researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Bergen

Bergen, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 32330315 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30985704 (View on PubMed)

Other Identifiers

2018/1361

Identifier Type: -

Identifier Source: org_study_id