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

Primary Purpose

Lateral Epicondylitis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Active PBMT-sMF
Placebo PBMT-sMF
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Photobiomodulation Therapy, Low-level Laser Therapy, Static Magnetic Fields, Epicondylitis, Intensity of Pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Laboratory of Phototherapy and Innovative Technologies in HealthRecruiting
  • Laboratory of Phototherapy and Innovative Technologies in HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active PBMT-sMF

Placebo PBMT-sMF

Arm Description

Active 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 will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.

Outcomes

Primary Outcome Measures

Degree of pain rating
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
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
The grip strength will be measured using a digital grip dynamometer type Jamar® Plus Digital Hand Dynamometer.
TNF-α (Tumor Necrosis Factor-alpha) levels
The TNF-α levels will be measured by blood samples through the enzyme-linked immunosorbent assay (ELISA).
Subject satisfaction with overall outcome rating
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
Adverse events will be measured by report.
Degree of pain rating
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'

Full Information

First Posted
March 29, 2021
Last Updated
June 10, 2021
Sponsor
University of Nove de Julho
Collaborators
Multi Radiance Medical
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1. Study Identification

Unique Protocol Identification Number
NCT04829734
Brief Title
Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With Lateral Epicondylitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
Collaborators
Multi Radiance Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
Photobiomodulation Therapy, Low-level Laser Therapy, Static Magnetic Fields, Epicondylitis, Intensity of Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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).
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active PBMT-sMF
Arm Type
Experimental
Arm Description
Active PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.
Arm Title
Placebo PBMT-sMF
Arm Type
Placebo Comparator
Arm Description
Placebo PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.
Intervention Type
Device
Intervention Name(s)
Active PBMT-sMF
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo PBMT-sMF
Intervention Description
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).
Primary Outcome Measure Information:
Title
Degree of pain rating
Description
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)
Secondary Outcome Measure Information:
Title
Forearm pain and disability
Description
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.
Time Frame
3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Title
Grip strength
Description
The grip strength will be measured using a digital grip dynamometer type Jamar® Plus Digital Hand Dynamometer.
Time Frame
3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Title
TNF-α (Tumor Necrosis Factor-alpha) levels
Description
The TNF-α levels will be measured by blood samples through the enzyme-linked immunosorbent assay (ELISA).
Time Frame
3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Title
Subject satisfaction with overall outcome rating
Description
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.
Time Frame
3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Title
Presence of adverse events
Description
Adverse events will be measured by report.
Time Frame
3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.
Title
Degree of pain rating
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ernesto Cesar Pinto Leal Junior, PhD
Phone
+55 11 33859134
Email
ernesto.leal.junior@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernesto Cesar Pinto Leal Junior, PhD
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Phototherapy and Innovative Technologies in Health
City
São Paulo
ZIP/Postal Code
01504-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ernesto Cesar Pinto Leal Junior, PhD
Phone
+55 11 33859134
Facility Name
Laboratory of Phototherapy and Innovative Technologies in Health
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ernesto Leal Junior, PhD
First Name & Middle Initial & Last Name & Degree
Ernesto Leal Junior

12. IPD Sharing Statement

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

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