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| Name | Class |
|---|---|
| Multi Radiance Medical | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active PBMT-sMF | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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' | 3 weeks (end of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ernesto Cesar Pinto Leal Junior, PhD | University of Nove de Julho | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory of Phototherapy and Innovative Technologies in Health | São Paulo | 01504-001 | Brazil | |||
| Laboratory of Phototherapy and Innovative Technologies in Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41047274 | Derived | 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. |
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The datasets generated and analyzed during the study are available from the corresponding author on reasonable request.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active PBMT-sMF | Active PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions. Active PBMT-sMF: 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. |
| FG001 | Placebo PBMT-sMF | Placebo 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: 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active PBMT-sMF | Active PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions. Active PBMT-sMF: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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' | Posted | Mean | Standard Deviation | units on a scale | 3 weeks (end of treatment) |
|
3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active PBMT-sMF | Active PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions. Active PBMT-sMF: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Biting sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Douglas Johnson, ATC, EES, CLS - Chief Science Officer, Clinical and Scientific Affairs | Multi Radiance Medical | 440-542-0761 | info@multiradiance.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2019 | Feb 5, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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A researcher will program the device (active PBMT-sMF or placebo PBMT-sMF) and will be instructed not to inform the patients or other researchers as to the type of treatment (active PBMT-sMF or placebo PBMT-sMF). Therefore, the researcher responsible for the treatment, the investigator and the outcome assessor will be blinded to the type of the treatment being administered to the patients. 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 PBMT-sMF or placebo PBMT-sMF).
|
| Placebo PBMT-sMF | Device | 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). |
|
| 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. | 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). | 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. | 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. | 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' | 4 weeks after the conclusion of the treatment. |
| São Paulo |
| Brazil |
| BG001 | Placebo PBMT-sMF | Placebo 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: 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Degree of pain rating (VAS) | Degree of pain rating was measured by 0-100 horizontal Visual Analog Pain Scale, with with 0 being 'no pain' and 100 'the worst possible pain'. | Mean | Standard Deviation | units on a scale |
|
| Forearm Pain and Disability | Were measured using the Patient-Rated Tennis Elbow Evaluation (PRTEE), which comprises 15 items divided into two subscales: a PAIN contained 5 questions about pain intensity (each item is rated from 0 = no pain and 10 = worst pain imaginable), and a FUCTION, contained 10 questions about how much difficulty the patient experiences when performing various daily or work-related tasks (each item is rated from 0 = no difficulty, 10 = inability to perform activities). These subscales are combined to yield a total score ranging from 0 to 100, with higher scores indicating greater impairment. | Mean | Standard Deviation | units on a scale |
|
| Grip Strength | The grip strength will be measured using a digital grip dynamometer type Jamar® Plus Digital Hand Dynamometer. | Mean | Standard Deviation | kgf |
|
| TNF-α (Tumor Necrosis Factor-alpha) Levels | The TNF-α levels will be measured by blood samples through the enzyme-linked immunosorbent assay (ELISA). | Mean | Standard Deviation | pg/ml |
|
| Placebo PBMT-sMF |
Placebo 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: 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). |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment. |
|
|
|
| Secondary | Grip Strength | The grip strength will be measured using a digital grip dynamometer type Jamar® Plus Digital Hand Dynamometer. | Posted | Mean | Standard Deviation | kgf | 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment. |
|
|
|
| Secondary | TNF-α (Tumor Necrosis Factor-alpha) Levels | The TNF-α levels will be measured by blood samples through the enzyme-linked immunosorbent assay (ELISA). | Posted | Mean | Standard Deviation | pg/ml | 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment. |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment. |
|
|
|
| Secondary | Presence of Adverse Events | Adverse events will be measured by report. | Posted | Number | participants | 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment. |
|
|
|
| Secondary | 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' | Posted | Mean | Standard Deviation | units on a scale | 4 weeks after the conclusion of the treatment. |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 2 |
| 25 |
| EG001 | Placebo PBMT-sMF | Placebo 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: 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). | 0 | 25 | 0 | 25 | 3 | 25 |
| Heating | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tingling sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| Function scores - 3 weeks (end of treatment) |
|
| Function scores - 4 weeks after the conclusion of the treatment |
|
| 3 weeks (end of treatment) - Unaffected/Untreated Limb |
|
| 4 weeks after the conclusion of the treatment - Unaffected/Untreated Limb |
|
| Neither |
|
| Not Very Satisfied |
|
| Not at All Satisfied |
|
| 4 weeks after the conclusion of the treatment |
|
| Pain and discomfort |
|
| Tingling sensation |
|