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

Sponsor

University of Nove de Julho (Other)

Overall Status

Recruiting

CT.gov ID

NCT04829734

Collaborator

Multi Radiance Medical (Industry)

Enrollment

Locations

Arms

4.7

Anticipated Duration (Months)

Patients Per Site

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lateral Epicondylitis	Device: Active PBMT-sMF Device: Placebo PBMT-sMF	N/A

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:

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.
The secondary outcomes that are continuous variables will be analyzed through parametric analysis using ANCOVA. Statistical significance will be set at p<0.05.
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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).

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 12, 2021

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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 Comparator: 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.	Device: 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).

Arm

Intervention/Treatment

Experimental: 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.

Device: 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 Comparator: 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.

Device: 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).

Outcome Measures

Primary Outcome Measures

Degree of pain rating [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 Outcome Measures

Forearm pain and disability [3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.]
Forearm pain and disability will be measured by Patient-Rated Forearm Evaluation Questionnaire, which is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis. The questionnaire rates from 0 to 10 for each question, and consists of 2 subscales: PAIN subscale (0 = no pain, 10 = worst imaginable) and FUNCTION subscale (0 = no difficulty, 10 = unable to do). To the individual subscale scores, a total score can be computed on a scale of 100 (0 = no disability and 100 = worse disability), where pain and functional problems are weighted equally.
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).
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.
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 [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'

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laboratory of Phototherapy and Innovative Technologies in Health	São Paulo		Brazil	01504-001
2	Laboratory of Phototherapy and Innovative Technologies in Health	São Paulo		Brazil