Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-02-20 @ 3:31 AM
Study NCT ID:
NCT03255733
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2017-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ITU Treatment for Chronic Epicondylitis Musculoskeletal Pain Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'r.amodei@guidedtherapy.com', 'phone': '480-649-8587', 'title': 'Rich Amodei, RDMS', 'organization': 'Guided Therapy Systems'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'While the protocol involved Chronic patients, who had already failed Standard of Care regimens, it is a limitation for this investigational study to have no control group.'}}, 'adverseEventsModule': {'timeFrame': '2 Years', 'description': 'Any self-reported adverse event occurring after the first treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Intense Therapeutic Ultrasound Treatment', 'description': 'Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.\n\nIntense Therapeutic Ultrasound Treatment', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients Reporting at Least 25% Overall Pain Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intense Therapeutic Ultrasound Treatment', 'description': 'Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.\n\nIntense Therapeutic Ultrasound Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after 1st Treatment', 'description': 'Percentage of Patients Reporting at least 25% pain reduction compared to baseline, using Universal Visual Analog Scale (VAS) Pain Score. VAS is a 10-point Pain Scale, where 0 = No Pain, 1 = Slight Pain and 10 = the Patients Worst Imaginable Pain. Scales in between represent 10% increments of Pain ( Range 1 - 10).', 'unitOfMeasure': 'percentage of patients with less pain', 'reportingStatus': 'POSTED', 'populationDescription': 'Percentage of Patients reporting at least 25% improvement in Pain at 12 Weeks after the first treatment'}, {'type': 'SECONDARY', 'title': 'Average Pain Score Change as Reported Using Patient Rated Tennis Elbow Evaluation, During Normal Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intense Therapeutic Ultrasound Treatment', 'description': 'Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.\n\nIntense Therapeutic Ultrasound Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '-58', 'groupId': 'OG000', 'lowerLimit': '-100', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after 1st Treatment', 'description': 'Average Percentage of Pain Change as Reported using Patient-Rated Tennis Elbow Evaluation Survey, compared to baseline. Range (± 100%)', 'unitOfMeasure': 'percentage of reported pain change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intense Therapeutic Ultrasound Treatment', 'description': 'Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.\n\nIntense Therapeutic Ultrasound Treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intense Therapeutic Ultrasound Treatment', 'description': 'Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.\n\nIntense Therapeutic Ultrasound Treatment'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-05-04', 'size': 2569140, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-08-14T17:07', 'hasProtocol': True}, {'date': '2015-03-02', 'size': 372013, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2017-08-16T14:34', 'hasProtocol': False}, {'date': '2015-03-02', 'size': 415253, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2017-08-16T14:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Investigator was blinded to the Patient Reported Outcome Measure Survey details and analysis.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients age 18 - 85, previously diagnosed with Chronic Lateral Epicondylitis, with symptoms exceeding 90 days, and where Standard of Care treatments have failed to resolve the symptoms.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-19', 'studyFirstSubmitDate': '2017-08-10', 'resultsFirstSubmitDate': '2017-08-21', 'studyFirstSubmitQcDate': '2017-08-17', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-19', 'studyFirstPostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients Reporting at Least 25% Overall Pain Reduction', 'timeFrame': '12 weeks after 1st Treatment', 'description': 'Percentage of Patients Reporting at least 25% pain reduction compared to baseline, using Universal Visual Analog Scale (VAS) Pain Score. VAS is a 10-point Pain Scale, where 0 = No Pain, 1 = Slight Pain and 10 = the Patients Worst Imaginable Pain. Scales in between represent 10% increments of Pain ( Range 1 - 10).'}], 'secondaryOutcomes': [{'measure': 'Average Pain Score Change as Reported Using Patient Rated Tennis Elbow Evaluation, During Normal Activities', 'timeFrame': '12 weeks after 1st Treatment', 'description': 'Average Percentage of Pain Change as Reported using Patient-Rated Tennis Elbow Evaluation Survey, compared to baseline. Range (± 100%)'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Chronic Lateral Epicondylitis', 'Tennis Elbow', 'Intense Therapeutic Ultrasound (ITU)', 'Guided Therapy Systems (GTS)', 'Ardent Sound, Inc.', 'Actisound'], 'conditions': ['Tennis Elbow']}, 'referencesModule': {'references': [{'pmid': '17224484', 'type': 'BACKGROUND', 'citation': 'White WM, Makin IR, Barthe PG, Slayton MH, Gliklich RE. Selective creation of thermal injury zones in the superficial musculoaponeurotic system using intense ultrasound therapy: a new target for noninvasive facial rejuvenation. Arch Facial Plast Surg. 2007 Jan-Feb;9(1):22-9. doi: 10.1001/archfaci.9.1.22.'}, {'pmid': '20115948', 'type': 'BACKGROUND', 'citation': 'Alam M, White LE, Martin N, Witherspoon J, Yoo S, West DP. Ultrasound tightening of facial and neck skin: a rater-blinded prospective cohort study. J Am Acad Dermatol. 2010 Feb;62(2):262-9. doi: 10.1016/j.jaad.2009.06.039.'}, {'pmid': '17372061', 'type': 'BACKGROUND', 'citation': 'Gliklich RE, White WM, Slayton MH, Barthe PG, Makin IR. Clinical pilot study of intense ultrasound therapy to deep dermal facial skin and subcutaneous tissues. Arch Facial Plast Surg. 2007 Mar-Apr;9(2):88-95. doi: 10.1001/archfaci.9.2.88.'}, {'pmid': '18429926', 'type': 'BACKGROUND', 'citation': 'Laubach HJ, Makin IR, Barthe PG, Slayton MH, Manstein D. Intense focused ultrasound: evaluation of a new treatment modality for precise microcoagulation within the skin. Dermatol Surg. 2008 May;34(5):727-34. doi: 10.1111/j.1524-4725.2008.34196.x.'}, {'pmid': '12696985', 'type': 'BACKGROUND', 'citation': 'Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. doi: 10.2165/00007256-200333050-00004.'}, {'pmid': '24049221', 'type': 'BACKGROUND', 'citation': 'Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.'}, {'pmid': '12851352', 'type': 'BACKGROUND', 'citation': 'DiGiovanni BF, Nawoczenski DA, Lintal ME, Moore EA, Murray JC, Wilding GE, Baumhauer JF. Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients with chronic heel pain. A prospective, randomized study. J Bone Joint Surg Am. 2003 Jul;85(7):1270-7. doi: 10.2106/00004623-200307000-00013.'}, {'pmid': '17254903', 'type': 'BACKGROUND', 'citation': 'Rompe JD, Overend TJ, MacDermid JC. Validation of the Patient-rated Tennis Elbow Evaluation Questionnaire. J Hand Ther. 2007 Jan-Mar;20(1):3-10; quiz 11. doi: 10.1197/j.jht.2006.10.003.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness, safety and patient tolerance for the use of Intense Therapeutic Ultrasound (ITU) for chronic, subcutaneous lateral Epicondylitis musculoskeletal tissue pain reduction began in July 2015 and was completed in March 2017. The More Foundation/The Core Institute: Single-blinded pivotal study for the treatment of chronic lateral epicondylitis. A total 29 patients received 2 treatments, 4 weeks apart on subcutaneous musculoskeletal tissues along with Standard of Care treatments as prescribed by the Principal Investigator. Patients were followed for up to 6 months after the first treatment receiving a physical exam at each follow-up visit (4, 8 and 12 weeks) and provided feedback via Patient/Subject Reported Outcome Measure surveys specific to the treated anatomy at each visit and via phone follow-up at 26 weeks after the first treatment.', 'detailedDescription': "Intense therapeutic ultrasound (ITU) is an established ultrasound based therapy in which sound waves are concentrated and focused into selected musculoskeletal tissue, to produce selective thermal coagulative changes over a small controlled area while leaving the surrounding tissue unaffected. These coagulative changes are known to begin the body's tissue response cascade and promote collagen generation in the targeted anatomy resulting in pain reduction.\n\nITU has been used clinically for treating the subcutaneous musculoskeletal tissue below facial skin for the past decade and it has received CE Mark and FDA 510(k) clearance to market for non-surgical brow and submental tissue lifting. Over 3 Million patients worldwide have been treated using this technology. Clinical studies have shown that 85% of patients receiving this treatment on facial skin tissue showed an improvement in facial lifting with no significant pain, erythema, inflammation or scarring by creating the same coagulative changes to the connective tissue under the skin. Histologically, it has been shown that ITU induces the production of dermal collagen with thickening of the dermis and straightening of the elastic fibers in the reticular dermis.\n\nOn-going research in laboratory studies has shown that ITU can improve healing of damaged Achilles tendon in a rabbit model. Preliminary results showed an increase in precursor markers for collagen regeneration (e.g. Vascular endothelial growth factor A (VEGFa), tumor necrosis factor alpha (TNFα), Interleukin 1 beta (IL-1β), and Transforming growth factor beta 1 (TGFβ1)) and subsequent increase in collagen formation in injured rabbit tendons treated with ITU compared to injured, untreated rabbit tendons."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic Pain (\\>90 days) from previously diagnosed Lateral Epicondylitis, where "Standard of Care" regimens failed to relief pain in the affected anatomy.\n* No History of surgery to the affected anatomy.\n* No alternative treatment procedures within the last 90 days.\n* Unilateral Pain\n* Willingness to complete treatment and post treatment regimen as described.\n* Patients who have provided written and verbal informed consent.\n\nExclusion Criteria:\n\n* Patients currently enrolled in any other non-conservative, device, or Investigational New Device (IND) clinical trial, or who have participated in a clinical study involving the Common Extensor Tendon, thirty days prior to study initiation;\n* Patients who have participated in any other clinical study involving an investigational product 30 days prior to enrollment that, in the opinion of the Principal Investigator, could affect the outcome of this study;\n* Patients who have received previous treatment in the symptomatic limb (not including conservative treatment);\n* At the Principal Investigator\'s discretion, any patient that should be excluded based on their current condition or medical history.'}, 'identificationModule': {'nctId': 'NCT03255733', 'acronym': 'ITU', 'briefTitle': 'ITU Treatment for Chronic Epicondylitis Musculoskeletal Pain Reduction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guided Therapy Systems'}, 'officialTitle': 'Intense Therapeutic Ultrasound for Chronic, Subcutaneous Lateral Epicondylitis Musculoskeletal Pain Reduction', 'orgStudyIdInfo': {'id': 'GTS-ITU Epicondylosis 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intense Therapeutic Ultrasound Treatment', 'description': 'Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.', 'interventionNames': ['Device: Intense Therapeutic Ultrasound Treatment']}], 'interventions': [{'name': 'Intense Therapeutic Ultrasound Treatment', 'type': 'DEVICE', 'otherNames': ['Guided Therapy Systems, Ardent Sound, GTS, ITU', 'Actisound'], 'armGroupLabels': ['Intense Therapeutic Ultrasound Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'The More Foundation', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'John A Kearney, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The More Foundataion'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guided Therapy Systems', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'More Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}