Low Back PainPhase 1/2NCT04003545
Application of LED Photobiomodulation in the Treatment of Chronic Low Back Pain
A Phase 1/2 study testing LED Photobiomodulation in people with Low Back Pain, run by University of Nove de Julho.
Trial summary
Lumbar pain, or low back pain, may be defined as pain or discomfort located from the lower portion of the costal margin to the gluteal folds, with or without referred pain in the legs. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- LED Photobiomodulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2019to 1 Dec 2020
- Phase
- Phase 1/2
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical symptoms of vertebral pain that do not respond to symptomatic treatment with anti-inflammatory drugs for at least 3 months;
- Moderate to severe pain measured by Visual Analogue Scale (VAS> 4);
- Diagnosis of chronic nonspecific low back pain (as previously defined);
- Signed Informed Consent Form to participate in the study and availability to visit the clinic for treatment and evaluations.
Who cannot join
- Presence of other osteomuscular and rheumatic diseases;
- Presence of symptoms and signs of osteomioarticular disease, even if without known diagnosis;
- Clinical signs and complaints of osteomioarticular pain in the lower limbs (hips and ankles), as well as in spinal region;
- Use of Photobiomodulation up to 90 days before the inclusion;
- Clinical signs of neuropathy, including radiculopathy and peripheral nerve injury;
- Presence of systemic inflammatory diseases (rheumatoid arthritis, Reiter arthritis, spondylitis ankylosing, generalized polyarthritis, neoplasia);
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- Presence of metabolic or endocrine diseases;
- Presence of Fibromyalgia;
- Presence of serious psychiatric disorders with demands for specialist care;
- Use of steroids injections up to 48 hours before inclusion;
- Infection or tumor in the area of Photobiomodulation application;
- Presence of severe blood dyscrasias;
- Presence of blood clotting disorders (including local thrombosis);
- Use of oral anticoagulant;
- Presence of Affective Psychotic Disorder that hinders adherence to the treatment;
- History of lumbar surgery;
- Patients who submit to government benefits due to low back pain.
About this study
Official title: Application of LED Photobiomodulation in the Treatment of Chronic Low Back Pain: a Randomized, Double-blind Clinical Trial
Lumbar pain, or low back pain, may be defined as pain or discomfort located from the lower portion of the costal margin to the gluteal folds, with or without referred pain in the legs. This pain is classified as non-specific lumbar pain when its cause is unknown, as well as chronic when it persists for longer than three months with the appearance of disabilities for activities of daily life. Treatments for low back pain are usually pharmacological, focusing on analgesics, muscle relaxants and anti-inflammatories. Although protective factors, such as exercise, healthy diet and functional training may mitigate the evolution of pain, physical disability due to pain and functional loss reduce quality of life. Photobiomodulation (PBM) can be defined as the therapeutic use of light sources to reduce inflammation and relief pain. In this context, the objectives of this study are to develop and evaluate the effectiveness of an application protocol of an LED cluster for the treatment of chronic low back pain in a randomized, double-blind clinical trial that will be conducted in the outpatient facility of Universidade Nove de Julho (Uninove). Patients with chronic nonspecific low back pain, who signs the Informed Consent Form approved by the Uninove Institutional Review Board will be included in the study. Treatment sessions will be performed with a LED cluster three times a week for 4 weeks (totaling 12 sessions) in the lumbar region, and the outcomes will be measured with the following evaluations: VAS - Visual Analog Scale; Roland-Morris Disability Questionnaire (RMDQ); Schöber test; Modified Oswestry Disability Questionnaire and Algometry.
- Conditions
- Low Back Pain
- Being tested
- LED Photobiomodulation, Placebo LED Photobiomodulation
- 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.
LED PhotobiomodulationRadiation
A total of twelve laser applications (3 sessions per week) will be provided to the patients as treatment. A LED board with wavelengths of 660nm and 850nm at 5mW of power will be used for 30 minutes, resulting in a total energy of 3J per point in each session. The application site will be the lumbar region, in contact with the skin. The LED cluster (light-emitting diodes) has 72 LEDs.
Placebo LED PhotobiomodulationOther
For the placebo group, the procedures will be the same, however the LED equipment will remain off.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | Thirty eight patients will be recruited from UNINOVE outpatient units and randomly allocated in the two groups. Receives: Radiation: LED Photobiomodulation |
| Placebo group | Placebo comparator | Thirty eight patients will be recruited from UNINOVE outpatient units and randomly allocated in the two groups. Receives: Other: Placebo LED Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in low back pain assessed by VAS (visual analog scale)
Patients will be present with a 10-cm ruler in which 0 means total absence of pain and 10 the maximum pain.
Measured: Baseline (Before the first application of LED) and 4 weeks after (after the last application).
Secondary outcomes (4)
Change in disability assessed by Roland-Morris Disability Questionnaire (RMDQ)
This scale assesses physical abilities and psychological factors of patients, inquiring about functional changes of people with low back pain. It presents 24 questions about the conditions of the patient that characterize the presented incapacity. In all questions the phrase "because of my back" is added, and when it comes to answering them, the patient signals only the phrases that best suits him or her at that moment, otherwise the patient should go on to the next sentence. The total count of the marked items can range from a minimum of zero, considered no functional impairment, to a maximum of 24, high functional impairment.
Measured: Baseline (Before the first application of LED) and 4 weeks after (after the last application).
Change in range of motion assessed by Schöber test
the patient will remain in the orthostatic position while the examiner positions his thumbs at the lower margin of the posterior superior iliac spine (PSIS) and draws a horizontal line in the midline between these two structures.
Then, the examiner firmly holds the tip of a measuring tape against the patient's skin on the marked line and marks a second line 15 cm above the first. The patient is then asked to flex the anterior trunk without increasing pain and a new measurement is marked between the lower and upper marks; finally, the patient returns to the neutral position. The difference between the initial distance (between the two marks on the skin in the neutral position) and the new measurement in the flexed position indicates the mobility of the lumbar spine in centimeters, with precision of millimeters.
Measured: Baseline (Before the first application of LED) and 4 weeks after (after the last application).
Change in disability assessed by Modified Oswestry Disability Questionnaire
The Brazilian version of the Oswestry questionnaire allows the evaluation of the functional disability reported by the patients, based on the level of pain during different activities of daily life. This questionnaire contains ten questions about daily activities for evaluating the impact of pain on the performance of such activities. The results range from zero (minimum disability) to 100 (evident disability).
Measured: Baseline (Before the first application of LED) and 4 weeks after (after the last application).
Change in Pressure Pain Threshold
The Pressure Pain Threshold (PPT) will be evaluated with the J Tech algometer (XXX). The algometer is a hand device with a 1cm² diameter rod and a rubber cover in its tip. It allows the recording, through the electronic device, the pressure applied on a surface. For this evaluation, a pressure will be applied at a constant rate of 1kg/sec to the level at which pain or discomfort is reported by the volunteer who will be lying on a stretcher. The evaluated muscles will be: gluteus medius; tensor fasciae latae; tibialis anterior; proximal ischiotibial (ischium); paravertebral muscle (lumbar L2-L5 and sacral S1-S3).
Measured: Baseline (Before the first application of LED) and 4 weeks after (after the last application).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 Aug 2019 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003545
- Sponsor's protocol ID
- TFilippo
- Status last verified
- Jun 2019
- First submitted
- 25 Jun 2019
- Last updated
- 1 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of LED Photobiomodulation in the Treatment of Chronic Low Back Pain: a Randomized, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04003545
- Acronym / sponsor ID
- TFilippo
- Conditions
- Low Back Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 1 Jul 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.
Lumbar pain, or low back pain, may be defined as pain or discomfort located from the lower portion of the costal margin to the gluteal folds, with or without referred pain in the legs. This pain is classified as non-specific lumbar pain when its cause is unknown, as well as chronic when it persists for longer than three months with the appearance of disabilities for activities of daily life. Treatments for low back pain are usually pharmacological, focusing on analgesics, muscle relaxants and anti-inflammatories. Although protective factors, such as exercise, healthy diet and functional training may mitigate the evolution of pain, physical disability due to pain and functional loss reduce quality of life. Photobiomodulation (PBM) can be defined as the therapeutic use of light sources to reduce inflammation and relief pain. In this context, the objectives of this study are to develop and evaluate the effectiveness of an application protocol of an LED cluster for the treatment of chronic low back pain in a randomized, double-blind clinical trial that will be conducted in the outpatient facility of Universidade Nove de Julho (Uninove). Patients with chronic nonspecific low back pain, who signs the Informed Consent Form approved by the Uninove Institutional Review Board will be included in the study. Treatment sessions will be performed with a LED cluster three times a week for 4 weeks (totaling 12 sessions) in the lumbar region, and the outcomes will be measured with the following evaluations: VAS - Visual Analog Scale; Roland-Morris Disability Questionnaire (RMDQ); Schöber test; Modified Oswestry Disability Questionnaire and Algometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Radiation: LED PhotobiomodulationThirty eight patients will be recruited from UNINOVE outpatient units and randomly allocated in the two groups. |
| Placebo group | Placebo comparator | Other: Placebo LED PhotobiomodulationThirty eight patients will be recruited from UNINOVE outpatient units and randomly allocated in the two groups. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical symptoms of vertebral pain that do not respond to symptomatic treatment with anti-inflammatory drugs for at least 3 months;
- Moderate to severe pain measured by Visual Analogue Scale (VAS> 4);
- Diagnosis of chronic nonspecific low back pain (as previously defined);
- Signed Informed Consent Form to participate in the study and availability to visit the clinic for treatment and evaluations.
Key exclusion criteria (17 listed)
- Presence of other osteomuscular and rheumatic diseases;
- Presence of symptoms and signs of osteomioarticular disease, even if without known diagnosis;
- Clinical signs and complaints of osteomioarticular pain in the lower limbs (hips and ankles), as well as in spinal region;
- Use of Photobiomodulation up to 90 days before the inclusion;
- Clinical signs of neuropathy, including radiculopathy and peripheral nerve injury;
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 |
|---|---|---|
| LED PhotobiomodulationA total of twelve laser applications (3 sessions per week) will be provided to the patients as treatment. A LED board with wavelengths of 660nm and 850nm at 5mW of power will be used for 30 minutes, resulting in a total energy of 3J per point in each session. The application site will be the lumbar region, in contact with the skin. The LED cluster (light-emitting diodes) has 72 LEDs. | Radiation | Active group |
| Placebo LED PhotobiomodulationFor the placebo group, the procedures will be the same, however the LED equipment will remain off. | Other | Placebo group |
Primary outcome
Change in low back pain assessed by VAS (visual analog scale)
Time frame: Baseline (Before the first application of LED) and 4 weeks after (after the last application).
Patients will be present with a 10-cm ruler in which 0 means total absence of pain and 10 the maximum pain.
4 secondary outcomes
Change in disability assessed by Roland-Morris Disability Questionnaire (RMDQ)
Time frame: Baseline (Before the first application of LED) and 4 weeks after (after the last application).
Change in range of motion assessed by Schöber test
Time frame: Baseline (Before the first application of LED) and 4 weeks after (after the last application).
Change in disability assessed by Modified Oswestry Disability Questionnaire
Time frame: Baseline (Before the first application of LED) and 4 weeks after (after the last application).
Change in Pressure Pain Threshold
Time frame: Baseline (Before the first application of LED) and 4 weeks after (after the last application).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LED Photobiomodulation in people with Low Back Pain, run by University of Nove de Julho.
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 17 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 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in low back pain assessed by VAS (visual analog scale) (time frame: Baseline (Before the first application of LED) and 4 weeks after (after the last application).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2019.