Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With Lateral Epicondylitis

Evaluation of the Effects of Photobiomodulation Therapy Combined With Static Magnetic Field (PBMT-sMF) on Temporary Pain Relief in Patients With Lateral Epicondylitis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04829734

Enrollment

Registered

2021-04-02

Start date

2021-04-12

Completion date

2021-09-15

Last updated

2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lateral Epicondylitis

Keywords

Photobiomodulation Therapy, Low-level Laser Therapy, Static Magnetic Fields, Epicondylitis, Intensity of Pain

Brief 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. 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: 1. 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. 2. The secondary outcomes that are continuous variables will be analyzed through parametric analysis using ANCOVA. Statistical significance will be set at p\<0.05. 3. 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.

Interventions

DEVICEActive 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.

DEVICEPlacebo 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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).

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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; * 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.

Design outcomes

Primary

Measure	Time frame	Description
Degree of Pain Rating (VAS)	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'

Secondary

Measure	Time frame	Description
Grip Strength	3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.	The grip strength will be measured using a digital grip dynamometer type Jamar® Plus Digital Hand Dynamometer.
TNF-α (Tumor Necrosis Factor-alpha) Levels	3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.	The TNF-α levels will be measured by blood samples through the enzyme-linked immunosorbent assay (ELISA).
Forearm Pain and Disability	3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.	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.
Presence of Adverse Events	3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.	Adverse events will be measured by report.
Degree of Pain Rating (VAS)	4 weeks after the conclusion of the 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'
Subject Satisfaction With Overall Outcome Rating	3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.	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.

Countries

Brazil

Participant flow

Participants by arm

Arm	Count
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.	25
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).	25
Total	50

Baseline characteristics

Characteristic	Placebo PBMT-sMF	Active PBMT-sMF	Total
Age, Continuous	35.12 years STANDARD_DEVIATION 9.77	34.64 years STANDARD_DEVIATION 7.82	34.88 years STANDARD_DEVIATION 9.74
Degree of pain rating (VAS)	75.60 units on a scale STANDARD_DEVIATION 9.64	79.36 units on a scale STANDARD_DEVIATION 10.19	77.48 units on a scale STANDARD_DEVIATION 10
Forearm Pain and Disability	59.28 units on a scale STANDARD_DEVIATION 8.48	58.26 units on a scale STANDARD_DEVIATION 9.45	58.77 units on a scale STANDARD_DEVIATION 8.9
Grip Strength Affected/Treated Limb	24.24 kgf STANDARD_DEVIATION 12.04	23.13 kgf STANDARD_DEVIATION 8.16	23.69 kgf STANDARD_DEVIATION 10.19
Grip Strength Unaffected/ Untreated Limb	27.55 kgf STANDARD_DEVIATION 12.46	24.71 kgf STANDARD_DEVIATION 7.77	26.13 kgf STANDARD_DEVIATION 10.38
Race/Ethnicity, Customized African American	8 Participants	4 Participants	12 Participants
Race/Ethnicity, Customized Asian	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Caucasian	13 Participants	10 Participants	23 Participants
Race/Ethnicity, Customized Hispanic/Latino	4 Participants	10 Participants	14 Participants
Region of Enrollment Brazil	25 participants	25 participants	50 participants
Sex: Female, Male Female	13 Participants	12 Participants	25 Participants
Sex: Female, Male Male	12 Participants	13 Participants	25 Participants
TNF-α (Tumor Necrosis Factor-alpha) Levels	36.66 pg/ml STANDARD_DEVIATION 6.96	35.75 pg/ml STANDARD_DEVIATION 4.99	36.20 pg/ml STANDARD_DEVIATION 6.01

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 25	0 / 25
other Total, other adverse events	2 / 25	3 / 25
serious Total, serious adverse events	0 / 25	0 / 25

Outcome results

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'

Time frame: 3 weeks (end of treatment)

Arm	Measure	Value (MEAN)	Dispersion
Active PBMT-sMF	Degree of Pain Rating (VAS)	36.92 units on a scale	Standard Deviation 22.64
Placebo PBMT-sMF	Degree of Pain Rating (VAS)	51.40 units on a scale	Standard Deviation 19.84

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'

Time frame: 4 weeks after the conclusion of the treatment.

Arm	Measure	Value (MEAN)	Dispersion
Active PBMT-sMF	Degree of Pain Rating (VAS)	20.28 units on a scale	Standard Deviation 21.24
Placebo PBMT-sMF	Degree of Pain Rating (VAS)	37.40 units on a scale	Standard Deviation 24.08

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.