Low Back PainNCT05487118
PBMT Associated With MCE for Chronic Non- Specific Low Back Pain
A study testing Active PBMT + MCE in people with Low Back Pain, run by University of Nove de Julho at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Active PBMT + MCE
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 2 sitesBrazil
- Study dates
- 22 Aug 2022to Aug 2026
- 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 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.
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);
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-074
Laboratory of Phototherapy and Innovative Technologies in Health
São Paulo
About this study
Official title: Effects of Photobiomodulation Therapy (LASER) Associated With Motor Control Exercises 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.
Read the detailed description
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: comitedeetica@uninove.br Address: Vergueiro nº 235/249. Liberdade, Sao Paulo, Sao Paulo, Brazil
- Conditions
- Low Back Pain
- Being tested
- Placebo PBMT + MCE, Active PBMT + MCE
- Keywords
- Photobiomodulation Therapy, LLLT, Motor Control Exercise
- 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 PBMT + MCEDevice
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 + MCEDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: Active PBMT + MCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the end of treatment (6 weeks after randomization)
Secondary outcomes (6)
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.
Measured: 1 month after the end of the treatment, 3, 6 and 12 months 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.
Measured: 1 month after the end of the treatment, 3, 6 and 12 months after randomization
Levels of prostaglandin E2 (PGE2)
Levels of PGE2 will be measured by blood samples
Measured: At the end of treatment (6 weeks after randomization)
Medication intake
The medication intake will be measured from self-report
Measured: 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
Co-interventions will be measured from self-report
Measured: 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
Adverse events will be measured from self-report
Measured: At the end of treatment (6 weeks after randomization), 1 month after the end of treatment, 3, 6 and 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start22 Aug 2022
- Primary completion4 Mar 2024
- Study completionAug 2026 (estimated)
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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Principal investigator, Ernesto Cesar Pinto Leal Junior, University of Nove de Julho
- Investigators
- Shaiane Tomazoni, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487118
- Sponsor's protocol ID
- 5.289.714
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2022
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be available on reasonable request.
Publications
Tomazoni SS, de Oliveira MFD, Schardong J, Plentz RDM, Casalechi HL, Teixeira ILA, Serra AJ, Leal-Junior ECP, Bjordal JM. Photobiomodulation therapy has a negligible effect as an adjunct to motor control exercise in people with chronic non-specific low back pain: a randomised trial. J Physiother. 2026 Oct 12:S1836-9553(26)00102-5. doi: 10.1016/j.jphys.2026.09.005. Online ahead of print.
PubMed 42864195de 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.
PubMed 39345834
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photobiomodulation Therapy (LASER) Associated With Motor Control Exercises for Chronic Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT05487118
- Acronym / sponsor ID
- 5.289.714
- Conditions
- Low Back Pain
- Keywords
- Photobiomodulation Therapy, LLLT, Motor Control Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- Aug 2026 (estimated)
- First posted
- 4 Aug 2022 (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.
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.
Detailed description
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: comitedeetica@uninove.br Address: Vergueiro nº 235/249. Liberdade, Sao Paulo, Sao Paulo, Brazil
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 + MCE | Placebo comparator | Device: Placebo PBMT + MCEPlacebo photobiomodulation therapy (PBMT), with a dose of 0 J, will be applied before a protocol of motor control exercises (MCE). |
| Active PBMT + MCE | Active comparator | Device: Active PBMT + MCEActive photobiomodulation therapy (PBMT), with a dose of 30 J, will be applied before a protocol of motor control exercises (MCE). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 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);
- 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;
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 PBMT + MCEPlacebo 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. | Device | Placebo PBMT + MCE |
| Active PBMT + MCEActive 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. | Device | Active PBMT + MCE |
Primary outcome
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.
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.
6 secondary outcomes
Pain intensity
Time frame: 1 month after the end of the treatment, 3, 6 and 12 months after randomization
Disability
Time frame: 1 month after the end of the treatment, 3, 6 and 12 months after randomization
Levels of prostaglandin E2 (PGE2)
Time frame: At the end of treatment (6 weeks after randomization)
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Derived from this study: PubMed 42864195Tomazoni SS, de Oliveira MFD, Schardong J, Plentz RDM, Casalechi HL, Teixeira ILA, Serra AJ, Leal-Junior ECP, Bjordal JM. Photobiomodulation therapy has a negligible effect as an adjunct to motor control exercise in people with chronic non-specific low back pain: a randomised trial. J Physiother. 2026 Oct 12:S1836-9553(26)00102-5. doi: 10.1016/j.jphys.2026.09.005. Online ahead of print.
- Derived from this study: PubMed 39345834de 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.
- Individual participant dataSharing planned: Yes. The IPD will be available on reasonable request.
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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.
Shaiane Tomazoni, PhD principal investigator
University of Bergen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active PBMT + MCE in people with Low Back Pain, run by University of Nove de Julho at 2 sites in Brazil.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Results are not available in the source record.
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?
Pain intensity (time frame: At the end of treatment (6 weeks after randomization)). The study lists 2 primary outcomes in all. 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 NCT05487118, 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 5 Aug 2024.