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

NCT04829734 | Completed Results FDA Device

• 1 other identifier: 3.669.043
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Lateral Epicondylitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• Forearm Pain and Disability

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

• Grip Strength

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

• TNF-α (Tumor Necrosis Factor-alpha) Levels

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

• Subject Satisfaction With Overall Outcome Rating

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

• Presence of Adverse Events

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

Study Arms (2)

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.

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.

Device: Placebo PBMT-sMF

Interventions

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.

Active 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).

Placebo PBMT-sMF

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Nove de Julho: lead
• Multi Radiance Medical: collaborator

Study Sites (2)

Laboratory of Phototherapy and Innovative Technologies in Health

São Paulo, 01504-001, Brazil

Location

Laboratory of Phototherapy and Innovative Technologies in Health

São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 41047274 DERIVED

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Results Point of Contact

• Title: Douglas Johnson, ATC, EES, CLS - Chief Science Officer, Clinical and Scientific Affairs
• Organization: Multi Radiance Medical

info@multiradiance.com

440-542-0761

Study Officials

• Ernesto Cesar Pinto Leal Junior, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 2, 2021
• Study Start: April 12, 2021
• Primary Completion: August 15, 2021
• Study Completion: September 15, 2021
• Last Updated: August 29, 2025
• Results First Posted: May 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)