Low Back PainNCT03859505

Photobiomodulation Therapy on Inflammatory Mediators on Low Back Pain

A study testing Active PBMT in people with Low Back Pain, run by Universidade Cidade de Sao Paulo at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Low Back Pain
What is being tested?: Active PBMT
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteNorway
Study dates: 18 Mar 2019to 29 Mar 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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);

Trial locations and contacts

1 site in 1 country.

Norway1 site

University of Bergen
Bergen, N-5018

Other trials in Norway

About this study

Official title: Effects of Photobiomodulation Therapy on Inflammatory Mediators in Patients With Chronic Non-specific Low Back Pain: a Randomized Placebo-controlled Trial

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.

Read the 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
Being tested: Placebo PBMT, Active PBMT
Keywords: Low Back Pain, Photobiomodulation Therapy, PBMT, Low-Level Laser Therapy, LLLT
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo PBMTDevice
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 PBMTDevice
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.

Study groups in NCT03859505
Study group	Role	What they receive
Placebo PBMT	Placebo comparator	Application of PBMT (Photobiomodulation Therapy) without any dose (0 Joule). Receives: Device: Placebo PBMT
Active PBMT	Active comparator	Application of PBMT (Photobiomodulation Therapy) active. Receives: Device: Active PBMT

What is being measured

The primary outcome is the main question the study is designed to answer.

Levels of prostaglandin E2 (PGE2)
Inflammation will be measured by blood samples
Measured: 15 minutes after the treatment

Secondary outcomes (3)

Levels of tumor necrosis factor alpha (TNF-a)
Inflammation will be measured by blood samples.
Measured: 15 minutes after the treatment.
Levels of interleukin-6 (IL-6)
Inflammation will be measured by blood samples
Measured: 15 minutes after the treatment
Pain Intensity
Pain intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain Numerical Rating Scale), with 0 being "no pain" and 10 "the worst possible pain".
Measured: 15 minutes after the treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Mar 201929 Mar 2019

First posted1 Mar 2019
Study start18 Mar 2019
Primary completion29 Mar 2019
Study completion29 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03859505
Sponsor's protocol ID: 2018/1361
Status last verified: Mar 2019
First submitted: 27 Feb 2019
Last updated: 1 Apr 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The data will be available upon requested of principal investigator.

Publications

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.
PubMed 32330315
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.
PubMed 30985704

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Photobiomodulation Therapy on Inflammatory Mediators in Patients With Chronic Non-specific Low Back Pain: a Randomized Placebo-controlled Trial
ClinicalTrials.gov ID: NCT03859505
Acronym / sponsor ID: 2018/1361
Conditions: Low Back Pain
Keywords: Low Back Pain, Photobiomodulation Therapy, PBMT, Low-Level Laser Therapy, LLLT
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Universidade Cidade de Sao PauloUniversity, hospital or other
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Bergen
Study start: 18 Mar 2019 (actual)
Primary completion: 29 Mar 2019 (actual)
Study completion: 29 Mar 2019 (actual)
First posted: 1 Mar 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo PBMT	Placebo comparator	Device: Placebo PBMTApplication of PBMT (Photobiomodulation Therapy) without any dose (0 Joule).
Active PBMT	Active comparator	Device: Active PBMTApplication of PBMT (Photobiomodulation Therapy) active.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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;

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo PBMTThe 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.	Device	Placebo PBMT
Active PBMTThe 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.	Device	Active PBMT

Primary outcome

Levels of prostaglandin E2 (PGE2)
Time frame: 15 minutes after the treatment
Inflammation will be measured by blood samples

3 secondary outcomes

Levels of tumor necrosis factor alpha (TNF-a)
Time frame: 15 minutes after the treatment.
Levels of interleukin-6 (IL-6)
Time frame: 15 minutes after the treatment
Pain Intensity
Time frame: 15 minutes after the treatment.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
Derived from this study: PubMed 32330315Tomazoni 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.
Derived from this study: PubMed 30985704Tomazoni 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.
Individual participant dataSharing planned: Yes. The data will be available upon requested of principal investigator.

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active PBMT in people with Low Back Pain, run by Universidade Cidade de Sao Paulo at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Levels of prostaglandin E2 (PGE2) (time frame: 15 minutes after the treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03859505, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.