NCT04829734

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

Completed NA Results posted Last updated 29 August 2025

What this trial tests

NA trial testing Active PBMT-sMF in Lateral Epicondylitis in 50 participants. Completed in 15 September 2021.

Timeline

12 April 2021

Primary endpoint
15 August 2021

15 September 2021

Quick facts

Lead sponsor	University of Nove de Julho
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	50
Start date	12 April 2021
Primary completion	15 August 2021
Estimated completion	15 September 2021
Sites	2 locations across Brazil

Drugs / interventions tested

• Active PBMT-sMF
• Placebo PBMT-sMF

Conditions studied

• Lateral Epicondylitis — all drugs for Lateral Epicondylitis →

Sponsor

University of Nove de Julho

Who can join

Adults 18 to 50, any sex, with Lateral Epicondylitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Degree of Pain Rating (VAS) Primary · 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'

Group	Value	95% CI
Active PBMT-sMF	36.92	± 22.64
Placebo PBMT-sMF	51.40	± 19.84

Forearm Pain and Disability Secondary · 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.

Total scores - 3 weeks (end of treatment)

Group	Value	95% CI
Active PBMT-sMF	39.44	± 7.53
Placebo PBMT-sMF	40.88	± 8.61

Total scores - 4 weeks after the conclusion of the treatment

Group	Value	95% CI
Active PBMT-sMF	29.60	± 10.67
Placebo PBMT-sMF	33.34	± 9.68

Function scores - 3 weeks (end of treatment)

Group	Value	95% CI
Active PBMT-sMF	14.28	± 5.22
Placebo PBMT-sMF	15.49	± 8.61

Function scores - 4 weeks after the conclusion of the treatment

Group	Value	95% CI
Active PBMT-sMF	10.72	± 7.09
Placebo PBMT-sMF	11.14	± 6.36

Grip Strength Secondary · 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.

3 weeks (end of treatment) - Affected/Treated Limb

Group	Value	95% CI
Active PBMT-sMF	25.07	± 8.83
Placebo PBMT-sMF	26.37	± 12.70

4 weeks after the conclusion of the treatment - Affected/Treated Limb

Group	Value	95% CI
Active PBMT-sMF	25.97	± 7.53
Placebo PBMT-sMF	27.72	± 12.60

3 weeks (end of treatment) - Unaffected/Untreated Limb

Group	Value	95% CI
Active PBMT-sMF	25.45	± 9.28
Placebo PBMT-sMF	26.67	± 12.57

4 weeks after the conclusion of the treatment - Unaffected/Untreated Limb

Group	Value	95% CI
Active PBMT-sMF	26.07	± 8.72
Placebo PBMT-sMF	28.39	± 11.23

TNF-α (Tumor Necrosis Factor-alpha) Levels Secondary · 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).

3 weeks (end of treatment)

Group	Value	95% CI
Active PBMT-sMF	25.77	± 4.90
Placebo PBMT-sMF	33.14	± 4.71

4 weeks after the conclusion of the treatment

Group	Value	95% CI
Active PBMT-sMF	26.45	± 5.69
Placebo PBMT-sMF	32.00	± 6.11

Subject Satisfaction With Overall Outcome Rating Secondary · 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.

3 weeks (end of treatment)

Group	Value	95% CI
Active PBMT-sMF	18
Placebo PBMT-sMF	16
Active PBMT-sMF	6
Placebo PBMT-sMF	6
Active PBMT-sMF	1
Placebo PBMT-sMF	1
Active PBMT-sMF	0
Placebo PBMT-sMF	2

4 weeks after the conclusion of the treatment

Group	Value	95% CI
Active PBMT-sMF	21
Placebo PBMT-sMF	18
Active PBMT-sMF	3
Placebo PBMT-sMF	3
Active PBMT-sMF	1
Placebo PBMT-sMF	3
Active PBMT-sMF	0
Placebo PBMT-sMF	1

Presence of Adverse Events Secondary · 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.

Adverse events will be measured by report.

Biting sensation

Group	Value	95% CI
Active PBMT-sMF	1
Placebo PBMT-sMF	0

Heating of skin sensation

Group	Value	95% CI
Active PBMT-sMF	1
Placebo PBMT-sMF	0

Pain and discomfort

Group	Value	95% CI
Active PBMT-sMF	0
Placebo PBMT-sMF	2

Tingling sensation

Group	Value	95% CI
Active PBMT-sMF	0
Placebo PBMT-sMF	1

Degree of Pain Rating (VAS) Secondary · 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'

Group	Value	95% CI
Active PBMT-sMF	20.28	± 21.24
Placebo PBMT-sMF	37.40	± 24.08

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active PBMT-sMF

Serious: 0/25 (0%)

Deaths: 0/25

Placebo PBMT-sMF

Serious: 0/25 (0%)

Deaths: 0/25

Other adverse events (4 terms — click to expand)

Reaction	System	Active PBMT-sMF	Placebo PBMT-sMF
Pain	Musculoskeletal and connective tissue disorders	—	—
Biting sensation	Skin and subcutaneous tissue disorders	—	—
Heating	Skin and subcutaneous tissue disorders	—	—
Tingling sensation	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT04829734 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of photobiomodulation therapy combined with static magnetic field on pain and function in patients with lateral epicondylitis: a multicentre, randomised, placebo-controlled trial.
   de Oliveira MFD, Leal-Junior ECP, Machado CDSM, Ribeiro NF, et al · · 2025 · PMID 41047274 · DOI 10.1136/bmjopen-2025-104789