Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 6:03 PM
Study NCT ID:
NCT04829734
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2021-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With Lateral Epicondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013716', 'term': 'Tennis Elbow'}], 'ancestors': [{'id': 'D000070639', 'term': 'Elbow Tendinopathy'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@multiradiance.com', 'phone': '440-542-0761', 'title': 'Douglas Johnson, ATC, EES, CLS - Chief Science Officer, Clinical and Scientific Affairs', 'organization': 'Multi Radiance Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Active PBMT-sMF', 'description': 'Active PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nActive 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.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 2, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo PBMT-sMF', 'description': 'Placebo PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nPlacebo 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).', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 3, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Biting sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tingling sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Degree of Pain Rating (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active PBMT-sMF', 'description': 'Active PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nActive 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.'}, {'id': 'OG001', 'title': 'Placebo PBMT-sMF', 'description': 'Placebo PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nPlacebo 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).'}], 'classes': [{'categories': [{'measurements': [{'value': '36.92', 'spread': '22.64', 'groupId': 'OG000'}, {'value': '51.40', 'spread': '19.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks (end of treatment)', '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'", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Forearm Pain and Disability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active PBMT-sMF', 'description': 'Active PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nActive 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.'}, {'id': 'OG001', 'title': 'Placebo PBMT-sMF', 'description': 'Placebo PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nPlacebo 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).'}], 'classes': [{'title': 'Total scores - 3 weeks (end of treatment)', 'categories': [{'measurements': [{'value': '39.44', 'spread': '7.53', 'groupId': 'OG000'}, {'value': '40.88', 'spread': '8.61', 'groupId': 'OG001'}]}]}, {'title': 'Total scores - 4 weeks after the conclusion of the treatment', 'categories': [{'measurements': [{'value': '29.60', 'spread': '10.67', 'groupId': 'OG000'}, {'value': '33.34', 'spread': '9.68', 'groupId': 'OG001'}]}]}, {'title': 'Function scores - 3 weeks (end of treatment)', 'categories': [{'measurements': [{'value': '14.28', 'spread': '5.22', 'groupId': 'OG000'}, {'value': '15.49', 'spread': '8.61', 'groupId': 'OG001'}]}]}, {'title': 'Function scores - 4 weeks after the conclusion of the treatment', 'categories': [{'measurements': [{'value': '10.72', 'spread': '7.09', 'groupId': 'OG000'}, {'value': '11.14', 'spread': '6.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Grip Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active PBMT-sMF', 'description': 'Active PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nActive 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.'}, {'id': 'OG001', 'title': 'Placebo PBMT-sMF', 'description': 'Placebo PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nPlacebo 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).'}], 'classes': [{'title': '3 weeks (end of treatment) - Affected/Treated Limb', 'categories': [{'measurements': [{'value': '25.07', 'spread': '8.83', 'groupId': 'OG000'}, {'value': '26.37', 'spread': '12.70', 'groupId': 'OG001'}]}]}, {'title': '4 weeks after the conclusion of the treatment - Affected/Treated Limb', 'categories': [{'measurements': [{'value': '25.97', 'spread': '7.53', 'groupId': 'OG000'}, {'value': '27.72', 'spread': '12.60', 'groupId': 'OG001'}]}]}, {'title': '3 weeks (end of treatment) - Unaffected/Untreated Limb', 'categories': [{'measurements': [{'value': '25.45', 'spread': '9.28', 'groupId': 'OG000'}, {'value': '26.67', 'spread': '12.57', 'groupId': 'OG001'}]}]}, {'title': '4 weeks after the conclusion of the treatment - Unaffected/Untreated Limb', 'categories': [{'measurements': [{'value': '26.07', 'spread': '8.72', 'groupId': 'OG000'}, {'value': '28.39', 'spread': '11.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.', 'description': 'The grip strength will be measured using a digital grip dynamometer type Jamar® Plus Digital Hand Dynamometer.', 'unitOfMeasure': 'kgf', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'TNF-α (Tumor Necrosis Factor-alpha) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active PBMT-sMF', 'description': 'Active PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nActive 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.'}, {'id': 'OG001', 'title': 'Placebo PBMT-sMF', 'description': 'Placebo PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nPlacebo 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).'}], 'classes': [{'title': '3 weeks (end of treatment)', 'categories': [{'measurements': [{'value': '25.77', 'spread': '4.90', 'groupId': 'OG000'}, {'value': '33.14', 'spread': '4.71', 'groupId': 'OG001'}]}]}, {'title': '4 weeks after the conclusion of the treatment', 'categories': [{'measurements': [{'value': '26.45', 'spread': '5.69', 'groupId': 'OG000'}, {'value': '32.00', 'spread': '6.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.', 'description': 'The TNF-α levels will be measured by blood samples through the enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction With Overall Outcome Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active PBMT-sMF', 'description': 'Active PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nActive 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.'}, {'id': 'OG001', 'title': 'Placebo PBMT-sMF', 'description': 'Placebo PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nPlacebo 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).'}], 'classes': [{'title': '3 weeks (end of treatment)', 'categories': [{'title': 'Very satisfied', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Somewhat Satisfied', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Neither', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Not Very Satisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Not at All Satisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '4 weeks after the conclusion of the treatment', 'categories': [{'title': 'Very satisfied', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Somewhat Satisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Neither', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Not Very Satisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Not at All Satisfied', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.', '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Presence of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active PBMT-sMF', 'description': 'Active PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nActive 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.'}, {'id': 'OG001', 'title': 'Placebo PBMT-sMF', 'description': 'Placebo PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nPlacebo 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).'}], 'classes': [{'title': 'Biting sensation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Heating of skin sensation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pain and discomfort', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Tingling sensation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.', 'description': 'Adverse events will be measured by report.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Degree of Pain Rating (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active PBMT-sMF', 'description': 'Active PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nActive 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.'}, {'id': 'OG001', 'title': 'Placebo PBMT-sMF', 'description': 'Placebo PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nPlacebo 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).'}], 'classes': [{'categories': [{'measurements': [{'value': '20.28', 'spread': '21.24', 'groupId': 'OG000'}, {'value': '37.40', 'spread': '24.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks after the conclusion of the treatment.', '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'", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active PBMT-sMF', 'description': 'Active PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nActive 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.'}, {'id': 'FG001', 'title': 'Placebo PBMT-sMF', 'description': 'Placebo PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nPlacebo 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).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active PBMT-sMF', 'description': 'Active PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nActive 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.'}, {'id': 'BG001', 'title': 'Placebo PBMT-sMF', 'description': 'Placebo PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.\n\nPlacebo 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).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.64', 'spread': '7.82', 'groupId': 'BG000'}, {'value': '35.12', 'spread': '9.77', 'groupId': 'BG001'}, {'value': '34.88', 'spread': '9.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Degree of pain rating (VAS)', 'classes': [{'categories': [{'measurements': [{'value': '79.36', 'spread': '10.19', 'groupId': 'BG000'}, {'value': '75.60', 'spread': '9.64', 'groupId': 'BG001'}, {'value': '77.48', 'spread': '10.00', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Degree of pain rating was measured by 0-100 horizontal Visual Analog Pain Scale, with with 0 being 'no pain' and 100 'the worst possible pain'.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Forearm Pain and Disability', 'classes': [{'categories': [{'measurements': [{'value': '58.26', 'spread': '9.45', 'groupId': 'BG000'}, {'value': '59.28', 'spread': '8.48', 'groupId': 'BG001'}, {'value': '58.77', 'spread': '8.90', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Were measured using the Patient-Rated Tennis Elbow Evaluation (PRTEE), which comprises 15 items divided into two subscales: a PAIN contained 5 questions about pain intensity (each item is rated from 0 = no pain and 10 = worst pain imaginable), and a FUCTION, contained 10 questions about how much difficulty the patient experiences when performing various daily or work-related tasks (each item is rated from 0 = no difficulty, 10 = inability to perform activities). These subscales are combined to yield a total score ranging from 0 to 100, with higher scores indicating greater impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Grip Strength', 'classes': [{'title': 'Affected/Treated Limb', 'categories': [{'measurements': [{'value': '23.13', 'spread': '8.16', 'groupId': 'BG000'}, {'value': '24.24', 'spread': '12.04', 'groupId': 'BG001'}, {'value': '23.69', 'spread': '10.19', 'groupId': 'BG002'}]}]}, {'title': 'Unaffected/ Untreated Limb', 'categories': [{'measurements': [{'value': '24.71', 'spread': '7.77', 'groupId': 'BG000'}, {'value': '27.55', 'spread': '12.46', 'groupId': 'BG001'}, {'value': '26.13', 'spread': '10.38', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The grip strength will be measured using a digital grip dynamometer type Jamar® Plus Digital Hand Dynamometer.', 'unitOfMeasure': 'kgf', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'TNF-α (Tumor Necrosis Factor-alpha) Levels', 'classes': [{'categories': [{'measurements': [{'value': '35.75', 'spread': '4.99', 'groupId': 'BG000'}, {'value': '36.66', 'spread': '6.96', 'groupId': 'BG001'}, {'value': '36.20', 'spread': '6.01', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The TNF-α levels will be measured by blood samples through the enzyme-linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-18', 'size': 1236904, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-05T12:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2021-03-29', 'resultsFirstSubmitDate': '2025-02-12', 'studyFirstSubmitQcDate': '2021-04-01', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-05-06', 'studyFirstPostDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of Pain Rating (VAS)', 'timeFrame': '3 weeks (end of treatment)', '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'"}], 'secondaryOutcomes': [{'measure': 'Forearm Pain and Disability', 'timeFrame': '3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.', 'description': '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.'}, {'measure': 'Grip Strength', 'timeFrame': '3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.', 'description': 'The grip strength will be measured using a digital grip dynamometer type Jamar® Plus Digital Hand Dynamometer.'}, {'measure': 'TNF-α (Tumor Necrosis Factor-alpha) Levels', 'timeFrame': '3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.', 'description': 'The TNF-α levels will be measured by blood samples through the enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Subject Satisfaction With Overall Outcome Rating', 'timeFrame': '3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.', '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.'}, {'measure': 'Presence of Adverse Events', 'timeFrame': '3 weeks (end of treatment) and 4 weeks after the conclusion of the treatment.', 'description': 'Adverse events will be measured by report.'}, {'measure': 'Degree of Pain Rating (VAS)', 'timeFrame': '4 weeks after the conclusion of the treatment.', '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'"}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Photobiomodulation Therapy', 'Low-level Laser Therapy', 'Static Magnetic Fields', 'Epicondylitis', 'Intensity of Pain'], 'conditions': ['Lateral Epicondylitis']}, 'referencesModule': {'references': [{'pmid': '41047274', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nThe 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).\n\nStatistical analysis:\n\n1. 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.\n2. The secondary outcomes that are continuous variables will be analyzed through parametric analysis using ANCOVA. Statistical significance will be set at p\\<0.05.\n3. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with a history of pain around the lateral epicondyle for at least 1 month;\n* Self-reported Degree of Pain rating on the 0-100 VAS pain scale for the lateral epicondyle region is 50 or greater;\n* Tenderness localized to the epicondyle and anterodistal region of the epicondyle with palpation;\n* 2 of 4 positive results of provocative tests comprising of Maudsley's, Cozen's, Thomsen and Mill's tests;\n* Aged between 18 and 50 years;\n* Both genders;\n* Patients fluent in Portuguese.\n\nExclusion Criteria:\n\n* hemophilia or any type of blood clotting disorder;\n* chronic immune impairment neoplasia;\n* cancer or treatment for cancer in the past 6 months, including tumors of the spinal cord;\n* diabetes Type 1;\n* significant heart conditions including CHF and implantable heart devices such as a pacemaker;\n* current, active chronic pain disease: chronic fatigue syndrome, fibromyalgia, endometriosis, inflammatory bowel disease, interstitial cystitis diabetic neuropathic pain;\n* neurologic deficits;\n* cervical radiculopathy;\n* peripheral nerve disease;\n* rheumatoid arthritis;\n* shoulder disease;\n* radial tunnel syndrome;\n* previous surgery of the affected upper extremities;\n* congenital or acquired bony deformity in the ipsilateral upper extremity;\n* bilateral epicondylosis;\n* secondary orthopedic problems;\n* the initiation of opioid analgesia or corticosteroid or analgesic injection interventions within the previous 6 months;\n* local corticosteroids and/or botulinum toxin (Botox®) injection for Lateral Epicondyle pain relief within the prior 30 days;\n* medical tx; such as chiropractic care and acupuncture within last 30 days;\n* physical therapy intervention on the upper extremity in the previous year;\n* active infection, wound, or other external trauma to the areas to be treated with the laser;\n* medical, physical, or other contraindications for, or sensitivity to, light therapy;\n* serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years;\n* pregnant, breast feeding, or planning pregnancy prior to the end of study participation."}, 'identificationModule': {'nctId': 'NCT04829734', 'briefTitle': 'Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With Lateral Epicondylitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Nove de Julho'}, 'officialTitle': 'Evaluation of the Effects of Photobiomodulation Therapy Combined With Static Magnetic Field (PBMT-sMF) on Temporary Pain Relief in Patients With Lateral Epicondylitis', 'orgStudyIdInfo': {'id': '3.669.043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active PBMT-sMF', 'description': 'Active PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.', 'interventionNames': ['Device: Active PBMT-sMF']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo PBMT-sMF', 'description': 'Placebo PBMT-sMF will be applied two times a week (three to four days apart), for three consecutive weeks, yielding six treatment sessions.', 'interventionNames': ['Device: Placebo PBMT-sMF']}], 'interventions': [{'name': 'Active PBMT-sMF', 'type': 'DEVICE', '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.', 'armGroupLabels': ['Active PBMT-sMF']}, {'name': 'Placebo PBMT-sMF', 'type': 'DEVICE', '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).', 'armGroupLabels': ['Placebo PBMT-sMF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01504-001', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Laboratory of Phototherapy and Innovative Technologies in Health', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Laboratory of Phototherapy and Innovative Technologies in Health', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Ernesto Cesar Pinto Leal Junior, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nove de Julho'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The datasets generated and analyzed during the study are available from the corresponding author on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nove de Julho', 'class': 'OTHER'}, 'collaborators': [{'name': 'Multi Radiance Medical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ernesto Cesar Pinto Leal Junior', 'investigatorAffiliation': 'University of Nove de Julho'}}}}