Knee Pain ChronicNCT05830344
Effects of Multi Radiance Medical® Super Pulsed Laser on Chronic Knee Pain
A study testing Active Multi Radiance Medical® Super Pulsed Laser in people with Knee Pain Chronic, run by University of Nove de Julho at 2 sites in Brazil.
Trial summary
Knee pain is among the most common reasons for musculoskeletal pain consultations, accounting for nearly 4 million primary care visits annually. Knee pain can have different causes such as, tendinopathies, synovitis, bursitis, trauma, etc. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Knee Pain Chronic
- What is being tested?
- Active Multi Radiance Medical® Super Pulsed Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 2 sitesBrazil
- Study dates
- 27 Apr 2023to Dec 2023
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed consent form.
- Aged between 18 and 50 years, inclusive.
- Any gender.
- Subject is fluent in Portuguese.
- The volunteers' presenting primary (dominant) pain is in the region of the right or left knee only. i.e., it is unilateral.
- Self-reported degree of pain rating on the 0-100 VAS pain scale for the target knee is 50 or greater.
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- Self-reported degree of pain rating on the 0-100 VAS pain scale for the non-target knee is less than 20.
- Knee pain is episodic chronic, defined as having occurred and recurred over regular or irregular periods or intervals of time, persisting over at least the last 3 months.
- Volunteers' knee pain is of benign musculoskeletal origin wherein the etiology is tendinopathies, synovitis, bursitis, strain, and sprain, of traumatic or non-traumatic origin, as determined by the principal investigator based on any one or combination of the following:
- Prior diagnosis by a qualified licensed medical professional current within the last 2 years evidenced through source documentation.
- Previous Records Review, such as x-ray, MRI, CT scans, etc., where available, that indicate muscle or ligament injury and the absence of Degenerative Joint Disorder (DJD).
- Medical history consistent with one of the etiologies of knee pain falling within the scope of this study.
- Physical examination of the knee that yields one or both of the following findings: Increased pain upon range of motion and/or increased pain and weakness upon knee extension, knee flexion, or gait.
- Subject is willing and able to maintain his or her individualized pain regimen as determined by the study principal investigator at baseline as needed to manage any knee pain that may arise throughout the course of study duration, whilst refraining from consuming other over the counter and/or prescription medication(s) and/or herbal supplements intended for the relief of pain and/or inflammation, and/or partaking in other treatments/therapies.
Who cannot join
- A volunteer who satisfies any one or more of the following criteria will be excluded from study participation:
- The volunteers' presenting primary pain is located outside or in addition to the knee.
- The volunteers' presenting primary pain is bilateral, i.e., equally dominant in the right and left knees.
- Self-reported degree of pain rating on the 0-100 VAS pain scale for the target knee is less than 50.
- Self-reported degree of pain rating on the 0-100 VAS pain scale for the non-target knee is 20 or greater.
- Knee pain is acute, defined as having persisted less than half the time over less than the last 3 months.
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- Knee 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.
- Volunteers' knee pain is of other than, or in addition to, benign musculoskeletal origin wherein the etiology is tendinopathies, synovitis, bursitis, strains, and sprains from traumatic or non-traumatic origin, and/or the etiology of the subject's knee pain cannot be satisfactorily ruled out.
- Prior surgical intervention to the target knee that in the opinion of the principal investigator may affect the study treatment and or outcomes assessment.
- Neurologic deficits that in the opinion of the principal investigator may affect the study treatment and or outcomes assessment.
- Peripheral nerve disease.
- Rheumatoid arthritis.
- Hip or ankle disease.
- Congenital or acquired bony deformity in the ipsilateral lower extremity.
- Secondary orthopedic problems that in the opinion of the principal investigator may affect the study treatment and or outcomes assessment.
- Local corticosteroids and/or botulinum toxin (Botox®) injection for knee pain relief within 30 days prior to study enrollment.
- Treatments such as chiropractic care, and acupuncture 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.
- Pregnant, 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 past two years.
- Developmental disability or cognitive impairment that in the opinion of the principal investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
- Any other medical condition or medication use that in the opinion of the principal investigator may affect the study treatment and or outcomes assessment.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-074
Jociane Schardong, PhD, + 55 11 990065829, joci_fisioufsm@yahoo.com.br
- Recruiting
Laboratory of Phototherapy and Innovative Technologies in Health
São Paulo, 01504-001
Ernesto Cesar Pinto Leal Junior, PhD, +55 11 33859134
About this study
Official title: Evaluation of the Effect of Multi Radiance Medical® Super Pulsed Laser for Adjunctive Use in Providing Temporary Relief of Chronic Knee Pain of Musculoskeletal Origin
Knee pain is among the most common reasons for musculoskeletal pain consultations, accounting for nearly 4 million primary care visits annually. Knee pain can have different causes such as, tendinopathies, synovitis, bursitis, trauma, etc.
Considering the importance and high incidence of musculoskeletal disorders that affect the knee joint, a variety of therapeutic modalities has been employed to alleviate pain and repair the tissue. Among these conservative treatments, photobiomodulation therapy (PBMT) has been shown to stimulate tendon and ligament healing, and decrease the pain.
Therefore, the aim of this study is to determine the effectiveness of the Multi Radiance Medical® Super Pulsed Laser, manufactured by Multi Radiance Medical®, for adjunctive use in providing temporary relief of chronic knee pain of musculoskeletal origin.
Read the detailed description
To achieve the proposed objectives it will be performed a randomized, triple-blind (patients, therapists, outcome assessors), placebo-controlled trial, with voluntary patients with chronic knee pain. Eighty-six patients will be randomly allocated to two treatment groups: 1. Active Multi Radiance Medical® Super Pulsed Laser or Placebo Multi Radiance Medical® Super Pulsed Laser. The patients will be treated by a blinded therapist.
Treatment administration will be performed 3 times a week, for four consecutive weeks, yielding 12 treatments (each treatment administration one to two days apart).
The outcomes will be obtained at the stabilization phase, baseline (pre-procedure), end of treatment and one week after the conclusion of treatment.
The data will be collected by a blinded assessor. The statistical analysis will follow the intention-to-treat principles.
The project was also approved by the Research Ethics Committee from Universidade Nove de Julho, under the number 5.332.202. 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.
The investigators will analyze: degree of pain, levels of prostaglandin E2, subjective knee evaluation, patient satisfaction, blinded efficacy and adverse events.
- Conditions
- Knee Pain Chronic
- Being tested
- Placebo Multi Radiance Medical® Super Pulsed Laser, Active Multi Radiance Medical® Super Pulsed Laser
- Keywords
- Photobiomodulation Therapy, LLLT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Multi Radiance Medical® Super Pulsed LaserDevice
Placebo, without therapeutic dose.
Active Multi Radiance Medical® Super Pulsed LaserDevice
Active with a dose of 8.02 J per site.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo treatment will be irradiated using a Multi Radiance Medical Super Pulsed Laser, manufactured by Multi Radiance Medical® (Solon,Ohio, USA), at 5 sites in the knee area, without any emission of therapeutic dose. The treatment will be performed 3 times a week, for four consecutive weeks, yielding 12 treatments. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo). Receives: Device: Placebo Multi Radiance Medical® Super Pulsed Laser |
| Active | Experimental | Active treatment will be irradiated using a Multi Radiance Medical Super Pulsed Laser, manufactured by Multi Radiance Medical® (Solon,Ohio, USA), at 5 sites in the knee area, with a dose of 8.02 J per site. The treatment will be performed 3 times a week, for four consecutive weeks, yielding 12 treatments. Receives: Device: Active Multi Radiance Medical® Super Pulsed Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain rating
Degree of pain rating will be measured by 0-100 standardized Visual Analog Scale (VAS). Higher scores mean worse outcome.
Measured: 4 weeks (end of treatment).
Secondary outcomes (6)
Degree of pain rating
Degree of pain rating will be measured by 0-100 standardized Visual Analog Scale (VAS). Higher scores mean worse outcome.
Measured: One-week after the conclusion of the treatment.
Levels of Prostaglandin E2 (PGE2)
Levels of PGE2 will be measured by blood samples.
Measured: 4 weeks (end of treatment) and one-week after the conclusion of the treatment.
Subjective knee evaluation
Subjective knee evaluation will be measured by the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form consisting in 18 items and contains the following three domains: 1) symptoms, including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury (not included in the total score). Scores range from 0 points (lowest level of function and highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Measured: 4 weeks (end of treatment) and one-week after the conclusion of the treatment.
Patient satisfaction
Patient satisfaction will be measured by 1-item Likert Scale. The scale uses the following responses: very satisfied = 5; somewhat satisfied = 4; neither satisfied nor dissatisfied = 3; somewhat dissatisfied n=2; very dissatisfied =1. Highest scores indicates better satisfaction.
Measured: 4 weeks (end of treatment) and one-week after the conclusion of the treatment.
Blinding efficacy
The blinding efficacy will be measured by the percentage of volunteers and outcome assessor who correctly perceived their procedure group assignment and the percentage of volunteers and outcome assessor who did not correctly perceive their procedure group .
Measured: 4 weeks (end of treatment) and one-week after the conclusion of the treatment.
Adverse events
Adverse events will be measured by report.
Measured: 4 weeks (end of treatment) and one-week after the conclusion of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start27 Apr 2023
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee Pain ChronicStudies 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
- 86 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830344
- Sponsor's protocol ID
- 5.767.644
- Status last verified
- Aug 2023
- First submitted
- 31 Mar 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The IPD will be available on reasonable request.
Publications
Leal-Junior ECP, Dias LB, Casalechi HL, Schardong J, Araujo-Silva OM, Della Mea Plentz R, Johnson DS, Tomazoni SS. Photobiomodulation therapy combined with a static magnetic field for chronic non-specific knee pain: protocol for a multicentre, randomised, triple-blind, placebo-controlled trial. BMJ Open. 2026 Aug 4;16(8):e118954. doi: 10.1136/bmjopen-2026-118954.
PubMed 42552011
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Multi Radiance Medical® Super Pulsed Laser for Adjunctive Use in Providing Temporary Relief of Chronic Knee Pain of Musculoskeletal Origin
- ClinicalTrials.gov ID
- NCT05830344
- Acronym / sponsor ID
- 5.767.644
- Conditions
- Knee Pain Chronic
- Keywords
- Photobiomodulation Therapy, LLLT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Multi Radiance Medical
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Apr 2023 (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.
Knee pain is among the most common reasons for musculoskeletal pain consultations, accounting for nearly 4 million primary care visits annually. Knee pain can have different causes such as, tendinopathies, synovitis, bursitis, trauma, etc.
Considering the importance and high incidence of musculoskeletal disorders that affect the knee joint, a variety of therapeutic modalities has been employed to alleviate pain and repair the tissue. Among these conservative treatments, photobiomodulation therapy (PBMT) has been shown to stimulate tendon and ligament healing, and decrease the pain.
Therefore, the aim of this study is to determine the effectiveness of the Multi Radiance Medical® Super Pulsed Laser, manufactured by Multi Radiance Medical®, for adjunctive use in providing temporary relief of chronic knee pain of musculoskeletal origin.
Detailed description
To achieve the proposed objectives it will be performed a randomized, triple-blind (patients, therapists, outcome assessors), placebo-controlled trial, with voluntary patients with chronic knee pain. Eighty-six patients will be randomly allocated to two treatment groups: 1. Active Multi Radiance Medical® Super Pulsed Laser or Placebo Multi Radiance Medical® Super Pulsed Laser. The patients will be treated by a blinded therapist.
Treatment administration will be performed 3 times a week, for four consecutive weeks, yielding 12 treatments (each treatment administration one to two days apart).
The outcomes will be obtained at the stabilization phase, baseline (pre-procedure), end of treatment and one week after the conclusion of treatment.
The data will be collected by a blinded assessor. The statistical analysis will follow the intention-to-treat principles.
The project was also approved by the Research Ethics Committee from Universidade Nove de Julho, under the number 5.332.202. 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.
The investigators will analyze: degree of pain, levels of prostaglandin E2, subjective knee evaluation, patient satisfaction, blinded efficacy and adverse events.
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 | Placebo comparator | Device: Placebo Multi Radiance Medical® Super Pulsed LaserPlacebo treatment will be irradiated using a Multi Radiance Medical Super Pulsed Laser, manufactured by Multi Radiance Medical® (Solon,Ohio, USA), at 5 sites in the knee area, without any emission of therapeutic dose. The treatment will be performed 3 times a week, for four consecutive weeks, yielding 12 treatments. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo). |
| Active | Experimental | Device: Active Multi Radiance Medical® Super Pulsed LaserActive treatment will be irradiated using a Multi Radiance Medical Super Pulsed Laser, manufactured by Multi Radiance Medical® (Solon,Ohio, USA), at 5 sites in the knee area, with a dose of 8.02 J per site. The treatment will be performed 3 times a week, for four consecutive weeks, yielding 12 treatments. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Signed consent form.
- Aged between 18 and 50 years, inclusive.
- Any gender.
- Subject is fluent in Portuguese.
- The volunteers' presenting primary (dominant) pain is in the region of the right or left knee only. i.e., it is unilateral.
Key exclusion criteria (27 listed)
- A volunteer who satisfies any one or more of the following criteria will be excluded from study participation:
- The volunteers' presenting primary pain is located outside or in addition to the knee.
- The volunteers' presenting primary pain is bilateral, i.e., equally dominant in the right and left knees.
- Self-reported degree of pain rating on the 0-100 VAS pain scale for the target knee is less than 50.
- Self-reported degree of pain rating on the 0-100 VAS pain scale for the non-target knee is 20 or greater.
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 Multi Radiance Medical® Super Pulsed LaserPlacebo, without therapeutic dose. | Device | Placebo |
| Active Multi Radiance Medical® Super Pulsed LaserActive with a dose of 8.02 J per site. | Device | Active |
Primary outcome
Degree of pain rating
Time frame: 4 weeks (end of treatment).
Degree of pain rating will be measured by 0-100 standardized Visual Analog Scale (VAS). Higher scores mean worse outcome.
6 secondary outcomes
Degree of pain rating
Time frame: One-week after the conclusion of the treatment.
Levels of Prostaglandin E2 (PGE2)
Time frame: 4 weeks (end of treatment) and one-week after the conclusion of the treatment.
Subjective knee evaluation
Time frame: 4 weeks (end of treatment) and one-week after the conclusion of the treatment.
Patient satisfaction
Time frame: 4 weeks (end of treatment) and one-week after the conclusion of the treatment.
Blinding efficacy
Time frame: 4 weeks (end of treatment) and one-week after the conclusion of the treatment.
Adverse events
Time frame: 4 weeks (end of treatment) and one-week after the conclusion of the treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 42552011Leal-Junior ECP, Dias LB, Casalechi HL, Schardong J, Araujo-Silva OM, Della Mea Plentz R, Johnson DS, Tomazoni SS. Photobiomodulation therapy combined with a static magnetic field for chronic non-specific knee pain: protocol for a multicentre, randomised, triple-blind, placebo-controlled trial. BMJ Open. 2026 Aug 4;16(8):e118954. doi: 10.1136/bmjopen-2026-118954.
- 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.
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 Multi Radiance Medical® Super Pulsed Laser in people with Knee Pain Chronic, 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 14 inclusion and 27 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 14 Aug 2023. 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?
Contact Ernesto 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?
Degree of pain rating (time frame: 4 weeks (end of 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 NCT05830344, which also lists 1 linked publication.
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 14 Aug 2023.