Trial Outcomes & Findings for Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With Lateral Epicondylitis (NCT NCT04829734)

NCT ID: NCT04829734

Last Updated: 2025-08-29

Results Overview

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'

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

3 weeks (end of treatment)

Results posted on

2025-08-29

Participant Flow

Participant milestones

Participant milestones
Measure
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.
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).
Overall Study
STARTED
25
25
Overall Study
COMPLETED
25
25
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Active PBMT-sMF
n=25 Participants
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.
Placebo PBMT-sMF
n=25 Participants
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).
Total
n=50 Participants
Total of all reporting groups
Age, Continuous
34.64 years
STANDARD_DEVIATION 7.82 • n=5 Participants
35.12 years
STANDARD_DEVIATION 9.77 • n=7 Participants
34.88 years
STANDARD_DEVIATION 9.74 • n=5 Participants
Sex: Female, Male
Female
12 Participants
n=5 Participants
13 Participants
n=7 Participants
25 Participants
n=5 Participants
Sex: Female, Male
Male
13 Participants
n=5 Participants
12 Participants
n=7 Participants
25 Participants
n=5 Participants
Race/Ethnicity, Customized
Caucasian
10 Participants
n=5 Participants
13 Participants
n=7 Participants
23 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic/Latino
10 Participants
n=5 Participants
4 Participants
n=7 Participants
14 Participants
n=5 Participants
Race/Ethnicity, Customized
African American
4 Participants
n=5 Participants
8 Participants
n=7 Participants
12 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Region of Enrollment
Brazil
25 participants
n=5 Participants
25 participants
n=7 Participants
50 participants
n=5 Participants
Degree of pain rating (VAS)
79.36 units on a scale
STANDARD_DEVIATION 10.19 • n=5 Participants
75.60 units on a scale
STANDARD_DEVIATION 9.64 • n=7 Participants
77.48 units on a scale
STANDARD_DEVIATION 10.00 • n=5 Participants
Forearm Pain and Disability
58.26 units on a scale
STANDARD_DEVIATION 9.45 • n=5 Participants
59.28 units on a scale
STANDARD_DEVIATION 8.48 • n=7 Participants
58.77 units on a scale
STANDARD_DEVIATION 8.90 • n=5 Participants
Grip Strength
Affected/Treated Limb
23.13 kgf
STANDARD_DEVIATION 8.16 • n=5 Participants
24.24 kgf
STANDARD_DEVIATION 12.04 • n=7 Participants
23.69 kgf
STANDARD_DEVIATION 10.19 • n=5 Participants
Grip Strength
Unaffected/ Untreated Limb
24.71 kgf
STANDARD_DEVIATION 7.77 • n=5 Participants
27.55 kgf
STANDARD_DEVIATION 12.46 • n=7 Participants
26.13 kgf
STANDARD_DEVIATION 10.38 • n=5 Participants
TNF-α (Tumor Necrosis Factor-alpha) Levels
35.75 pg/ml
STANDARD_DEVIATION 4.99 • n=5 Participants
36.66 pg/ml
STANDARD_DEVIATION 6.96 • n=7 Participants
36.20 pg/ml
STANDARD_DEVIATION 6.01 • n=5 Participants

PRIMARY outcome

Timeframe: 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'

Outcome measures

Outcome measures
Measure
Active PBMT-sMF
n=25 Participants
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.
Placebo PBMT-sMF
n=25 Participants
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).
Degree of Pain Rating (VAS)
36.92 units on a scale
Standard Deviation 22.64
51.40 units on a scale
Standard Deviation 19.84

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Active PBMT-sMF
n=25 Participants
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.
Placebo PBMT-sMF
n=25 Participants
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).
Forearm Pain and Disability
Total scores - 3 weeks (end of treatment)
39.44 units on a scale
Standard Deviation 7.53
40.88 units on a scale
Standard Deviation 8.61
Forearm Pain and Disability
Total scores - 4 weeks after the conclusion of the treatment
29.60 units on a scale
Standard Deviation 10.67
33.34 units on a scale
Standard Deviation 9.68
Forearm Pain and Disability
Function scores - 3 weeks (end of treatment)
14.28 units on a scale
Standard Deviation 5.22
15.49 units on a scale
Standard Deviation 8.61
Forearm Pain and Disability
Function scores - 4 weeks after the conclusion of the treatment
10.72 units on a scale
Standard Deviation 7.09
11.14 units on a scale
Standard Deviation 6.36

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Active PBMT-sMF
n=25 Participants
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.
Placebo PBMT-sMF
n=25 Participants
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).
Grip Strength
3 weeks (end of treatment) - Affected/Treated Limb
25.07 kgf
Standard Deviation 8.83
26.37 kgf
Standard Deviation 12.70
Grip Strength
4 weeks after the conclusion of the treatment - Affected/Treated Limb
25.97 kgf
Standard Deviation 7.53
27.72 kgf
Standard Deviation 12.60
Grip Strength
3 weeks (end of treatment) - Unaffected/Untreated Limb
25.45 kgf
Standard Deviation 9.28
26.67 kgf
Standard Deviation 12.57
Grip Strength
4 weeks after the conclusion of the treatment - Unaffected/Untreated Limb
26.07 kgf
Standard Deviation 8.72
28.39 kgf
Standard Deviation 11.23

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Active PBMT-sMF
n=25 Participants
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.
Placebo PBMT-sMF
n=25 Participants
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).
TNF-α (Tumor Necrosis Factor-alpha) Levels
3 weeks (end of treatment)
25.77 pg/ml
Standard Deviation 4.90
33.14 pg/ml
Standard Deviation 4.71
TNF-α (Tumor Necrosis Factor-alpha) Levels
4 weeks after the conclusion of the treatment
26.45 pg/ml
Standard Deviation 5.69
32.00 pg/ml
Standard Deviation 6.11

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Active PBMT-sMF
n=25 Participants
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.
Placebo PBMT-sMF
n=25 Participants
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).
Subject Satisfaction With Overall Outcome Rating
3 weeks (end of treatment) · Very satisfied
18 Participants
16 Participants
Subject Satisfaction With Overall Outcome Rating
3 weeks (end of treatment) · Somewhat Satisfied
6 Participants
6 Participants
Subject Satisfaction With Overall Outcome Rating
3 weeks (end of treatment) · Neither
1 Participants
1 Participants
Subject Satisfaction With Overall Outcome Rating
3 weeks (end of treatment) · Not Very Satisfied
0 Participants
2 Participants
Subject Satisfaction With Overall Outcome Rating
3 weeks (end of treatment) · Not at All Satisfied
0 Participants
0 Participants
Subject Satisfaction With Overall Outcome Rating
4 weeks after the conclusion of the treatment · Very satisfied
21 Participants
18 Participants
Subject Satisfaction With Overall Outcome Rating
4 weeks after the conclusion of the treatment · Somewhat Satisfied
3 Participants
3 Participants
Subject Satisfaction With Overall Outcome Rating
4 weeks after the conclusion of the treatment · Neither
1 Participants
3 Participants
Subject Satisfaction With Overall Outcome Rating
4 weeks after the conclusion of the treatment · Not Very Satisfied
0 Participants
1 Participants
Subject Satisfaction With Overall Outcome Rating
4 weeks after the conclusion of the treatment · Not at All Satisfied
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.

Adverse events will be measured by report.

Outcome measures

Outcome measures
Measure
Active PBMT-sMF
n=25 Participants
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.
Placebo PBMT-sMF
n=25 Participants
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).
Presence of Adverse Events
Tingling sensation
0 participants
1 participants
Presence of Adverse Events
Biting sensation
1 participants
0 participants
Presence of Adverse Events
Heating of skin sensation
1 participants
0 participants
Presence of Adverse Events
Pain and discomfort
0 participants
2 participants

SECONDARY outcome

Timeframe: 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'

Outcome measures

Outcome measures
Measure
Active PBMT-sMF
n=25 Participants
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.
Placebo PBMT-sMF
n=25 Participants
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).
Degree of Pain Rating (VAS)
20.28 units on a scale
Standard Deviation 21.24
37.40 units on a scale
Standard Deviation 24.08

Adverse Events

Active PBMT-sMF

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Placebo PBMT-sMF

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Active PBMT-sMF
n=25 participants at risk
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.
Placebo PBMT-sMF
n=25 participants at risk
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).
Skin and subcutaneous tissue disorders
Biting sensation
4.0%
1/25 • Number of events 1 • 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
0.00%
0/25 • 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Skin and subcutaneous tissue disorders
Heating
4.0%
1/25 • Number of events 6 • 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
0.00%
0/25 • 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Musculoskeletal and connective tissue disorders
Pain
0.00%
0/25 • 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
8.0%
2/25 • Number of events 3 • 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Skin and subcutaneous tissue disorders
Tingling sensation
0.00%
0/25 • 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
4.0%
1/25 • Number of events 1 • 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.

Additional Information

Douglas Johnson, ATC, EES, CLS - Chief Science Officer, Clinical and Scientific Affairs

Multi Radiance Medical

Phone: 440-542-0761

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place