Low Back PainNCT06549660
PBMT in Providing Temporary Relief of Low Back Pain of Musculoskeletal Origin
A study testing Active PBMT in people with Low Back Pain, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of PBMT for adjunctive use in providing temporary relief of minor chronic low back pain of musculoskeletal origin. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Aug 2024to 1 Oct 2025
- 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 low back pain, defined as having occurred and recurred over regular or irregular periods or intervals of time, persisting over at least the last 3 months;
- Fluent in Portuguese;
- Pain intensity (self reported) of at least 50 mm measured by a 0-100 VAS pain scale;
- Pain of benign musculoskeletal origin wherein the etiology is tendinopathies, synovitis, bursitis, strain, and sprain, of traumatic or non-traumatic origin, as determined by the outcome assessor based on any one or combination of the following: (i) Prior diagnosis by a qualified licensed medical professional current within the last 2 years evidenced through source documentation; (ii) Previous records review, such as x-ray, MRI, CT scans, etc., where available, that indicate muscle or ligament injury and the absence of radiculopathies, fractures, tumors, and infectious diseases;
- Patient willing and able to maintain the individualized pain regimen (it will be determined in the first phase of the study and it will comprise what the patient can use or cannot use to manage any low back pain that may arise throughout the course of study duration).
Who cannot join
- Pain intensity (self reported) of less than 50 mm measured by a 0-100 VAS scale;
- Acute low back pain, defined as having persisted less than half the time over less than the last 3 months;
- Pain is not episodic, such that it has either been continually present without respite over the past 3 months and/or there has not been recurrent episodes within the past 3 months;
- Pain is of other than, or in addition to, benign musculoskeletal origin;
- Prior surgical intervention to the intended treatment area that in the opinion of the outcome assessor may affect the study treatment and or outcomes assessment;
- Neurologic deficit(s) that in the opinion of the outcome assessor may affect the study treatment and or outcomes assessment;
Show all 19Show fewer
- Peripheral nerve disease;
- Secondary orthopedic problem(s) that in the opinion of the outcome assessor may affect the study treatment and or outcomes assessment;
- Local corticosteroid and/or botulinum toxin (Botox®) injection for pain relief in or around the intended treatment area within 30 days prior to study enrollment;
- Treatments such as chiropractic care, and acupuncture targeting the intended treatment area(s) within 30 days prior to study enrollment;
- Current, active chronic pain disease, such as chronic fatigue syndrome, fibromyalgia, endometriosis, inflammatory bowel disease, interstitial cystitis diabetic neuropathic pain;
- Current cancer or treatment for cancer in the past 6 months;
- Significant heart conditions including chronic heart failure (CHF) and implantable heart devices such as a pacemaker;
- Active infection, wound, or other external trauma to the areas to be treated with the PBMT;
- Medical, physical, or other contraindications for, or sensitivity to, light therapy;
- Pregnancy, breast feeding, or planning pregnancy prior to the end of study participation;
- Female subject of childbearing age who is unwilling to engage in effective medical contraceptive use while sexually active during the study procedure administration phase;
- Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years;
- Developmental disability or cognitive impairment that in the opinion of the outcome assessor would preclude adequate comprehension of the informed consent form and/or ability to record the study outcome assessments.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Laboratory of Phototherapy and Innovative Technologies in Health
São Paulo, 01504-001
Ernesto Cesar Pinto Leal Junior, PhD, +55 11 3385 9134
Ernesto Cesar Pinto Leal Junior, Ph.D.
About this study
Official title: Combination of Super Pulsed Lasers and LEDs (PBMT) for Adjunctive Use in Providing Temporary Relief of Minor Chronic Low Back Pain of Musculoskeletal Origin
The goal of this clinical trial is to evaluate the effectiveness of PBMT for adjunctive use in providing temporary relief of minor chronic low back pain of musculoskeletal origin.
The main questions it aims to answer are:
(i) Is PBMT able to decrease pain intensity in patients with chronic low back pain of musculoskeletal origin? (ii) Is PBMT able to decrease disability in patients with chronic low back pain of musculoskeletal origin?
Researchers will compare active PBMT with placebo PBMT to see if active PBMT provides temporary relief of minor chronic low back pain of musculoskeletal origin.
Read the detailed description
To achieve the proposed objective it will be performed a randomized, triple-blinded (patients, therapists, and outcome assessors), placebo-controlled randomized study.
Sixty-eight patients will be randomly allocated to two treatment groups:
- Active treatment: Thirty-four patients will receive treatment with active PBMT.
- Placebo treatment: Thirty-four patients will receive treatment with placebo PBMT.
The treatment administration protocol will comprise: six sessions of treatment (with active or placebo PBMT, according to the previous randomization), two sessions a week, for three consecutive weeks, each procedure administration three to four days apart.
The data will be collected by a blinded assessor.
The study will comprise the following stages/phases:
- Pre procedure phase activities: (a) signing of informed consent form; (b) assignment of subject identification number; (c) randomization of subject to procedure group; (d) initial study qualification evaluation.
- Rescue pain management stabilization phase: (a) determination and recording of the individualized rescue pain management regimen; (b) VAS recording; (c) continued study eligibility evaluation.
- Pre-procedure administration phase activities: (a) pre-procedure variables recorded; (b) recording of pre-procedure measures.
- Procedure administration phase activities: (a) establishment of procedure administration visit schedule; (b) study procedure administration; (c) study procedure administration protocol; (d) procedure administration phase visits and evaluations.
- Post-procedure administration phase: one-month (30±4 days) period immediately following completion of the procedure administration phase.
The statistical analysis will follow the intention-to-treat principles as primary analysis, and per-protocol analysis will be secondary supportive analysis.
- Conditions
- Low Back Pain
- Being tested
- Active PBMT, Placebo PBMT
- Keywords
- Photobiomodulation therapy, Pain intensity, Disability
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active PBMTDevice
Active with a dose of 165 J per site, resulting in a total dose of 495J.
Placebo PBMTDevice
Placebo, without therapeutic dose.
| Study group | Role | What they receive |
|---|---|---|
| Placebo PBMT | Placebo comparator | Placebo PBMT will be applied twice weekly (three to four days apart) for three consecutive weeks, resulting in six treatment sessions. The placebo treatment will be applied in three zones: a) inferior to transverse process at L3-L4 left; b) intervertebral spaces between L3-L4; and c) inferior to transverse process at L3-L4 right. Receives: Device: Placebo PBMT |
| Active PBMT | Experimental | Active PBMT will be applied twice weekly (three to four days apart) for three consecutive weeks, resulting in six treatment sessions. The active treatment will be applied in three zones: a) inferior to transverse process at L3-L4 left; b) intervertebral spaces between L3-L4; and c) inferior to transverse process at L3-L4 right. Receives: Device: Active PBMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of individual subject successes
Measured through degree of pain rating measured by an 0-100 mm (0-10 cm) Visual Analog Scale (VAS), that evaluates the degree of pain perceived by the patient on a scale ranging from 0 to 100, with 0 being 'no pain' and 10 'the worst pain imaginable'. Higher scores mean worse outcome.
Measured: 15 minutes after the final treatment (6th).
Secondary outcomes (2)
Degree of pain
Degree of pain will be measured by an 0-100 mm (0-10 cm) Visual Analog Scale (VAS), that evaluates the degree of pain perceived by the patient on a scale ranging from 0 to 100, with 0 being 'no pain' and 10 'the worst pain imaginable'. Higher scores mean worse outcome.
Measured: 15 minutes after the final treatment (6th) and one month after the final treatment.
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: 15 minutes after the final treatment (6th) and one month after the final treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start20 Aug 2024
- Primary completion20 Aug 2025 (estimated)
- Study completion1 Oct 2025 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Multi Radiance Medical
- Responsible party
- Principal investigator, Ernesto Cesar Pinto Leal Junior, University of Nove de Julho
- Investigators
- Ernesto Cesar Pinto Leal Junior, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549660
- Sponsor's protocol ID
- 6.493.277
- Status last verified
- Sep 2024
- First submitted
- 8 Aug 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Super Pulsed Lasers and LEDs (PBMT) for Adjunctive Use in Providing Temporary Relief of Minor Chronic Low Back Pain of Musculoskeletal Origin
- ClinicalTrials.gov ID
- NCT06549660
- Acronym / sponsor ID
- 6.493.277
- Conditions
- Low Back Pain
- Keywords
- Photobiomodulation therapy, Pain intensity, Disability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Multi Radiance Medical
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 20 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 12 Aug 2024 (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.
The goal of this clinical trial is to evaluate the effectiveness of PBMT for adjunctive use in providing temporary relief of minor chronic low back pain of musculoskeletal origin.
The main questions it aims to answer are:
(i) Is PBMT able to decrease pain intensity in patients with chronic low back pain of musculoskeletal origin? (ii) Is PBMT able to decrease disability in patients with chronic low back pain of musculoskeletal origin?
Researchers will compare active PBMT with placebo PBMT to see if active PBMT provides temporary relief of minor chronic low back pain of musculoskeletal origin.
Detailed description
To achieve the proposed objective it will be performed a randomized, triple-blinded (patients, therapists, and outcome assessors), placebo-controlled randomized study.
Sixty-eight patients will be randomly allocated to two treatment groups:
- Active treatment: Thirty-four patients will receive treatment with active PBMT.
- Placebo treatment: Thirty-four patients will receive treatment with placebo PBMT.
The treatment administration protocol will comprise: six sessions of treatment (with active or placebo PBMT, according to the previous randomization), two sessions a week, for three consecutive weeks, each procedure administration three to four days apart.
The data will be collected by a blinded assessor.
The study will comprise the following stages/phases:
- Pre procedure phase activities: (a) signing of informed consent form; (b) assignment of subject identification number; (c) randomization of subject to procedure group; (d) initial study qualification evaluation.
- Rescue pain management stabilization phase: (a) determination and recording of the individualized rescue pain management regimen; (b) VAS recording; (c) continued study eligibility evaluation.
- Pre-procedure administration phase activities: (a) pre-procedure variables recorded; (b) recording of pre-procedure measures.
- Procedure administration phase activities: (a) establishment of procedure administration visit schedule; (b) study procedure administration; (c) study procedure administration protocol; (d) procedure administration phase visits and evaluations.
- Post-procedure administration phase: one-month (30±4 days) period immediately following completion of the procedure administration phase.
The statistical analysis will follow the intention-to-treat principles as primary analysis, and per-protocol analysis will be secondary supportive analysis.
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 PBMTPlacebo PBMT will be applied twice weekly (three to four days apart) for three consecutive weeks, resulting in six treatment sessions. The placebo treatment will be applied in three zones: a) inferior to transverse process at L3-L4 left; b) intervertebral spaces between L3-L4; and c) inferior to transverse process at L3-L4 right. |
| Active PBMT | Experimental | Device: Active PBMTActive PBMT will be applied twice weekly (three to four days apart) for three consecutive weeks, resulting in six treatment sessions. The active treatment will be applied in three zones: a) inferior to transverse process at L3-L4 left; b) intervertebral spaces between L3-L4; and c) inferior to transverse process at L3-L4 right. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients seeking care for chronic low back pain, defined as having occurred and recurred over regular or irregular periods or intervals of time, persisting over at least the last 3 months;
- Fluent in Portuguese;
- Pain intensity (self reported) of at least 50 mm measured by a 0-100 VAS pain scale;
- Pain of benign musculoskeletal origin wherein the etiology is tendinopathies, synovitis, bursitis, strain, and sprain, of traumatic or non-traumatic origin, as determined by the outcome assessor based on any one or combination of the following: (i) Prior diagnosis by a qualified licensed medical professional current within the last 2 years evidenced through source documentation; (ii) Previous records review, such as x-ray, MRI, CT scans, etc., where available, that indicate muscle or ligament injury and the absence of radiculopathies, fractures, tumors, and infectious diseases;
- Patient willing and able to maintain the individualized pain regimen (it will be determined in the first phase of the study and it will comprise what the patient can use or cannot use to manage any low back pain that may arise throughout the course of study duration).
Key exclusion criteria (19 listed)
- Pain intensity (self reported) of less than 50 mm measured by a 0-100 VAS scale;
- Acute low back pain, defined as having persisted less than half the time over less than the last 3 months;
- Pain is not episodic, such that it has either been continually present without respite over the past 3 months and/or there has not been recurrent episodes within the past 3 months;
- Pain is of other than, or in addition to, benign musculoskeletal origin;
- Prior surgical intervention to the intended treatment area that in the opinion of the outcome assessor may affect the study treatment and or outcomes assessment;
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 |
|---|---|---|
| Active PBMTActive with a dose of 165 J per site, resulting in a total dose of 495J. | Device | Active PBMT |
| Placebo PBMTPlacebo, without therapeutic dose. | Device | Placebo PBMT |
Primary outcome
Proportion of individual subject successes
Time frame: 15 minutes after the final treatment (6th).
Measured through degree of pain rating measured by an 0-100 mm (0-10 cm) Visual Analog Scale (VAS), that evaluates the degree of pain perceived by the patient on a scale ranging from 0 to 100, with 0 being 'no pain' and 10 'the worst pain imaginable'. Higher scores mean worse outcome.
2 secondary outcomes
Degree of pain
Time frame: 15 minutes after the final treatment (6th) and one month after the final treatment.
Disability
Time frame: 15 minutes after the final treatment (6th) and one month after the final treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: No
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.
Ernesto Cesar Pinto Leal Junior, PhD principal investigator
University of Nove de Julho
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 University of Nove de Julho at 1 site 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 5 inclusion and 19 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 4 Sep 2024. 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 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?
Contact Ernesto Cesar Pinto Leal Junior, PhD (+551133859134, ernesto.leal.junior@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of individual subject successes (time frame: 15 minutes after the final treatment (6th).). 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 4 Sep 2024.