Lateral EpicondylitisNCT04829734
Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With Lateral Epicondylitis
A study testing Active PBMT-sMF in people with Lateral Epicondylitis, run by University of Nove de Julho at 2 sites in Brazil.
Trial summary
Lateral epicondylitis (LE) is one of the most frequently encountered lesions affecting the upper extremity and is the most common cause of elbow pain in adults. It occurs on the lateral side of the elbow where the common extensors originate from the lateral epicondyle. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Active PBMT-sMF
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesBrazil
- Study dates
- 12 Apr 2021to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with a history of pain around the lateral epicondyle for at least 1 month;
- Self-reported Degree of Pain rating on the 0-100 VAS pain scale for the lateral epicondyle region is 50 or greater;
- Tenderness localized to the epicondyle and anterodistal region of the epicondyle with palpation;
- 2 of 4 positive results of provocative tests comprising of Maudsley's, Cozen's, Thomsen and Mill's tests;
- Aged between 18 and 50 years;
- Both genders;
- Patients fluent in Portuguese.
Who cannot join
- hemophilia or any type of blood clotting disorder;
- chronic immune impairment neoplasia;
- cancer or treatment for cancer in the past 6 months, including tumors of the spinal cord;
- diabetes Type 1;
- significant heart conditions including CHF and implantable heart devices such as a pacemaker;
- current, active chronic pain disease: chronic fatigue syndrome, fibromyalgia, endometriosis, inflammatory bowel disease, interstitial cystitis diabetic neuropathic pain;
Show all 24Show fewer
- neurologic deficits;
- cervical radiculopathy;
- peripheral nerve disease;
- rheumatoid arthritis;
- shoulder disease;
- radial tunnel syndrome;
- previous surgery of the affected upper extremities;
- congenital or acquired bony deformity in the ipsilateral upper extremity;
- bilateral epicondylosis;
- secondary orthopedic problems;
- the initiation of opioid analgesia or corticosteroid or analgesic injection interventions within the previous 6 months;
- local corticosteroids and/or botulinum toxin (Botox®) injection for Lateral Epicondyle pain relief within the prior 30 days;
- medical tx; such as chiropractic care and acupuncture within last 30 days;
- physical therapy intervention on the upper extremity in the previous year;
- active infection, wound, or other external trauma to the areas to be treated with the laser;
- medical, physical, or other contraindications for, or sensitivity to, light therapy;
- serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years;
- pregnant, breast feeding, or planning pregnancy prior to the end of study participation.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Laboratory of Phototherapy and Innovative Technologies in Health
São Paulo, 01504-001
Laboratory of Phototherapy and Innovative Technologies in Health
São Paulo
About this study
Official title: Evaluation of the Effects of Photobiomodulation Therapy Combined With Static Magnetic Field (PBMT-sMF) on Temporary Pain Relief in Patients With Lateral Epicondylitis
Lateral epicondylitis (LE) is one of the most frequently encountered lesions affecting the upper extremity and is the most common cause of elbow pain in adults. It occurs on the lateral side of the elbow where the common extensors originate from the lateral epicondyle. LE can be considered an overuse injury which occurs on the lateral side of the elbow in the extensor tendons with repetitive micro-trauma. The clinical presentation of LE involves a painful or burning sensation over the humeral insertion of the common extensor tendons. Despite the high incidence of LE, optimal treatment has not been established. Treatment options include therapeutic exercise, bracing, shock wave or ultrasound therapy , but many of them lack sufficient evidence of beneficial effects. Photobiomodulation therapy (PBMT) alone or combined with static magnetic field (PBMT-sMF) has been shown to stimulate tendon healing, this suggests that therapy using laser or light-emitting diodes (LEDs) is efficacious for the symptoms associated with epicondylitis. According to the favorable results of PBMT-sMF in tendons repair processes, this type of therapy can be used as a therapeutic tool for management in epicondylitis, therefore, more investigations are necessary to establish the ideal parameters. Therefore, the aim of this project is to investigate the effects of PBMT-sMF, in the appropriate parameters, on degree of pain and quality of life of patients with lateral epicondylitis.
Read the detailed description
To achieve the proposed objective it will be performed a multi-center, randomized, triple-blinded, placebo-controlled trial, with voluntary patients with lateral epicondylitis. Fifty patients will be randomly allocated to two treatment groups: 1. Active PBMT-sMF (MR5® Prototype Device) or Placebo PBMT-sMF (MR5® Prototype Device). The patients will be treated by a blinded therapist.
The patients randomly allocated to the different groups will be subjected to treatment two times a week for three consecutive weeks, each procedure administration three to four days apart.
The study will contain five phases: 1) pre-procedure activities; 2) pre-procedure assessment phase; 3) procedure administration phase; 4) procedure administration phase measures; 5) post-procedure administration phase.
The outcomes measured will be: degree of pain, forearm pain and disability, grip strength, TNF-α levels, subject satisfaction with overall outcome rating, perceived group assignment and adverse events.
The outcomes will be obtained at the stabilization phase (pre-procedure activities), baseline (pre-procedure assessment phase), 24 hours after the end of the treatment (procedure administration phase measures), and 30 days after the end of the treatment (post-procedure administration phase).
Statistical analysis:
- The primary statistical method to analyze the primary endpoint will be Fisher's exact test to compare the proportion of success between the test (Active PBMT-sMF) and the control (Placebo PBMT-sMF) groups, considering that randomization has been diligently conducted and important covariates between the two groups are well balanced. Statistical significance will be set at p<0.05.
- The secondary outcomes that are continuous variables will be analyzed through parametric analysis using ANCOVA. Statistical significance will be set at p<0.05.
- For patient satisfaction, measured through a Likert Scale, the data will be reduced to the nominal level by combining all agree and disagree responses into two categories of "accept" and "reject". Differences in satisfaction with Study Outcome Ratings between procedure groups at both evaluated time-points, and any change between. The chi-square will be used after this transformation. Statistical significance will be set at p<0.05.
- Conditions
- Lateral Epicondylitis
- Being tested
- Active PBMT-sMF, Placebo PBMT-sMF
- Keywords
- Photobiomodulation Therapy, Low-level Laser Therapy, Static Magnetic Fields, Epicondylitis, Intensity of Pain
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active PBMT-sMFDevice
The Active PBMT-sMF will be applied using MRM® MR5 Prototype manufactured by Multi Radiance Medical (Solon, OH, USA). PBMT-sMF will be applied using the direct contact method with light pressure on the skin. The PBMT-sMF will be applied in four regions of the epicondyle and the application time will be 60 seconds per region. The total dose of PBMT-sMF will be 108,30 J per treatment session.
Placebo PBMT-sMFDevice
The Placebo PBMT-sMF will be applied using MRM® MR5 Prototype manufactured by Multi Radiance Medical (Solon, OH, USA). Placebo PBMT-sMF will be applied using the direct contact method with light pressure on the skin. The Placebo PBMT-sMF will be applied in four regions of the epicondyle and the application time will be 60 seconds per region. The total dose of Placebo PBMT-sMF will be 0 J per treatment session and the sMF will be turned off. 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).
| Study group | Role | What they receive |
|---|---|---|
| Active PBMT-sMF | Experimental | Active PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions. Receives: Device: Active PBMT-sMF |
| Placebo PBMT-sMF | Placebo comparator | Placebo PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions. Receives: Device: Placebo PBMT-sMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Pain Rating (VAS)
Degree of pain rating will be measured by 0-100 horizontal Visual Analog Pain Scale, with with 0 being 'no pain' and 100 'the worst possible pain'
Measured: 3 weeks (end of treatment)
Secondary outcomes (6)
Forearm Pain and Disability
Were measured using the Patient-Rated Tennis Elbow Evaluation (PRTEE), a 15-item questionnaire comprising five items related to pain and ten items related to function. Each item is rated on an 11-point scale ranging from 0 to 10, where 0 indicates no pain or difficulty and 10 indicates the worst imaginable pain or complete inability to perform the activity. The pain subscale score is obtained by summing the five pain items, yielding a maximum score of 50. The function subscale is calculated by summing the ten function items and dividing the total by 2, also resulting in a maximum score of 50. The total PRTEE score is the sum of the pain and function subscale scores, ranging from 0 (no pain or disability) to 100 (maximum pain and disability), with higher scores indicating greater impairment.
Measured: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Grip Strength
The grip strength will be measured using a digital grip dynamometer type Jamar® Plus Digital Hand Dynamometer.
Measured: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
TNF-α (Tumor Necrosis Factor-alpha) Levels
The TNF-α levels will be measured by blood samples through the enzyme-linked immunosorbent assay (ELISA).
Measured: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Subject Satisfaction With Overall Outcome Rating
Subject satisfaction will be measured by 1-item Likert Scale. The scale uses the following responses: 5 = Very Satisfied; 4 = Somewhat Satisfied; 3 = Neither Satisfied nor Dissatisfied; 2 = Not Very Satisfied; 1 = Not at All Satisfied. Highest scores indicates better satisfaction.
Measured: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Presence of Adverse Events
Adverse events will be measured by report.
Measured: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Degree of Pain Rating (VAS)
Degree of pain rating will be measured by 0-100 horizontal Visual Analog Pain Scale, with with 0 being 'no pain' and 100 'the worst possible pain'
Measured: 4 weeks 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 posted2 Apr 2021
- Study start12 Apr 2021
- Primary completion15 Aug 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies 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
- 50 participants (actual)
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
- NCT04829734
- Sponsor's protocol ID
- 3.669.043
- Status last verified
- Aug 2025
- First submitted
- 29 Mar 2021
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The datasets generated and analyzed during the study are available from the corresponding author on reasonable request.
Publications
de Oliveira MFD, Leal-Junior ECP, Machado CDSM, Ribeiro NF, Dias LB, Lino MMA, Araujo-Silva OM, Casalechi HL, Johnson DS, Tomazoni SS. Effects of photobiomodulation therapy combined with static magnetic field on pain and function in patients with lateral epicondylitis: a multicentre, randomised, placebo-controlled trial. BMJ Open. 2025 Oct 5;15(10):e104789. doi: 10.1136/bmjopen-2025-104789.
PubMed 41047274
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Photobiomodulation Therapy Combined With Static Magnetic Field (PBMT-sMF) on Temporary Pain Relief in Patients With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT04829734
- Acronym / sponsor ID
- 3.669.043
- Conditions
- Lateral Epicondylitis
- Keywords
- Photobiomodulation Therapy, Low-level Laser Therapy, Static Magnetic Fields, Epicondylitis, Intensity of Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Multi Radiance Medical
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Posted 7 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lateral epicondylitis (LE) is one of the most frequently encountered lesions affecting the upper extremity and is the most common cause of elbow pain in adults. It occurs on the lateral side of the elbow where the common extensors originate from the lateral epicondyle. LE can be considered an overuse injury which occurs on the lateral side of the elbow in the extensor tendons with repetitive micro-trauma. The clinical presentation of LE involves a painful or burning sensation over the humeral insertion of the common extensor tendons. Despite the high incidence of LE, optimal treatment has not been established. Treatment options include therapeutic exercise, bracing, shock wave or ultrasound therapy , but many of them lack sufficient evidence of beneficial effects. Photobiomodulation therapy (PBMT) alone or combined with static magnetic field (PBMT-sMF) has been shown to stimulate tendon healing, this suggests that therapy using laser or light-emitting diodes (LEDs) is efficacious for the symptoms associated with epicondylitis. According to the favorable results of PBMT-sMF in tendons repair processes, this type of therapy can be used as a therapeutic tool for management in epicondylitis, therefore, more investigations are necessary to establish the ideal parameters. Therefore, the aim of this project is to investigate the effects of PBMT-sMF, in the appropriate parameters, on degree of pain and quality of life of patients with lateral epicondylitis.
Detailed description
To achieve the proposed objective it will be performed a multi-center, randomized, triple-blinded, placebo-controlled trial, with voluntary patients with lateral epicondylitis. Fifty patients will be randomly allocated to two treatment groups: 1. Active PBMT-sMF (MR5® Prototype Device) or Placebo PBMT-sMF (MR5® Prototype Device). The patients will be treated by a blinded therapist.
The patients randomly allocated to the different groups will be subjected to treatment two times a week for three consecutive weeks, each procedure administration three to four days apart.
The study will contain five phases: 1) pre-procedure activities; 2) pre-procedure assessment phase; 3) procedure administration phase; 4) procedure administration phase measures; 5) post-procedure administration phase.
The outcomes measured will be: degree of pain, forearm pain and disability, grip strength, TNF-α levels, subject satisfaction with overall outcome rating, perceived group assignment and adverse events.
The outcomes will be obtained at the stabilization phase (pre-procedure activities), baseline (pre-procedure assessment phase), 24 hours after the end of the treatment (procedure administration phase measures), and 30 days after the end of the treatment (post-procedure administration phase).
Statistical analysis:
- The primary statistical method to analyze the primary endpoint will be Fisher's exact test to compare the proportion of success between the test (Active PBMT-sMF) and the control (Placebo PBMT-sMF) groups, considering that randomization has been diligently conducted and important covariates between the two groups are well balanced. Statistical significance will be set at p<0.05.
- The secondary outcomes that are continuous variables will be analyzed through parametric analysis using ANCOVA. Statistical significance will be set at p<0.05.
- For patient satisfaction, measured through a Likert Scale, the data will be reduced to the nominal level by combining all agree and disagree responses into two categories of "accept" and "reject". Differences in satisfaction with Study Outcome Ratings between procedure groups at both evaluated time-points, and any change between. The chi-square will be used after this transformation. Statistical significance will be set at p<0.05.
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 |
|---|---|---|
| Active PBMT-sMF | Experimental | Device: Active PBMT-sMFActive PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions. |
| Placebo PBMT-sMF | Placebo comparator | Device: Placebo PBMT-sMFPlacebo PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients with a history of pain around the lateral epicondyle for at least 1 month;
- Self-reported Degree of Pain rating on the 0-100 VAS pain scale for the lateral epicondyle region is 50 or greater;
- Tenderness localized to the epicondyle and anterodistal region of the epicondyle with palpation;
- 2 of 4 positive results of provocative tests comprising of Maudsley's, Cozen's, Thomsen and Mill's tests;
- Aged between 18 and 50 years;
Key exclusion criteria (24 listed)
- hemophilia or any type of blood clotting disorder;
- chronic immune impairment neoplasia;
- cancer or treatment for cancer in the past 6 months, including tumors of the spinal cord;
- diabetes Type 1;
- significant heart conditions including CHF and implantable heart devices such as a pacemaker;
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 PBMT-sMFThe Active PBMT-sMF will be applied using MRM® MR5 Prototype manufactured by Multi Radiance Medical (Solon, OH, USA). PBMT-sMF will be applied using the direct contact method with light pressure on the skin. The PBMT-sMF will be applied in four regions of the epicondyle and the application time will be 60 seconds per region. The total dose of PBMT-sMF will be 108,30 J per treatment session. | Device | Active PBMT-sMF |
| Placebo PBMT-sMFThe Placebo PBMT-sMF will be applied using MRM® MR5 Prototype manufactured by Multi Radiance Medical (Solon, OH, USA). Placebo PBMT-sMF will be applied using the direct contact method with light pressure on the skin. The Placebo PBMT-sMF will be applied in four regions of the epicondyle and the application time will be 60 seconds per region. The total dose of Placebo PBMT-sMF will be 0 J per treatment session and the sMF will be turned off. 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). | Device | Placebo PBMT-sMF |
Primary outcome
Degree of Pain Rating (VAS)
Time frame: 3 weeks (end of treatment)
Degree of pain rating will be measured by 0-100 horizontal Visual Analog Pain Scale, with with 0 being 'no pain' and 100 'the worst possible pain'
6 secondary outcomes
Forearm Pain and Disability
Time frame: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Grip Strength
Time frame: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
TNF-α (Tumor Necrosis Factor-alpha) Levels
Time frame: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Subject Satisfaction With Overall Outcome Rating
Time frame: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Presence of Adverse Events
Time frame: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Degree of Pain Rating (VAS)
Time frame: 4 weeks after the conclusion of the treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41047274de Oliveira MFD, Leal-Junior ECP, Machado CDSM, Ribeiro NF, Dias LB, Lino MMA, Araujo-Silva OM, Casalechi HL, Johnson DS, Tomazoni SS. Effects of photobiomodulation therapy combined with static magnetic field on pain and function in patients with lateral epicondylitis: a multicentre, randomised, placebo-controlled trial. BMJ Open. 2025 Oct 5;15(10):e104789. doi: 10.1136/bmjopen-2025-104789.
- Individual participant dataSharing planned: No. The datasets generated and analyzed during the study are available from the corresponding author 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.
Ernesto Cesar Pinto Leal Junior, PhD principal investigator
University of Nove de Julho
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-sMF in people with Lateral Epicondylitis, 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 7 inclusion and 24 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 29 Aug 2025. 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?
Yes. Results are posted in the registry (first posted 7 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Degree of Pain Rating (VAS) (time frame: 3 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 NCT04829734, 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 29 Aug 2025.