Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT04549051
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2020-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Percutaneous Interruption of the Coracohumeral Ligament for the Treatment of Frozen Shoulder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002062', 'term': 'Bursitis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000779', 'term': 'Anesthetics, Local'}], 'ancestors': [{'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'swahezi@montefiore.org', 'phone': '718-920-7246', 'title': 'Sayed Wahezi, M.D.', 'organization': 'Albert Einstein College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This study represents a small population of patients with a CHL-related ROM deficit.'}}, 'adverseEventsModule': {'timeFrame': 'Each patient was followed for adverse events from the date of enrollment into the study until the date of their last follow-up, approximately 1 year.', 'eventGroups': [{'id': 'EG000', 'title': 'Tenex Plus Local Anesthetic Alone', 'description': "Use of the TENEX device for sectioning of the CHL\n\nThere were 30 subjects directly enrolled to TENEX group and 1 out of these 30 subjects had SAE.\n\nAfter 9 Subjects' crossing over, there were totally 39 subject who got the TENEX procedure in this group.\n\n3 out of 9 crossed over subjects had SAE after crossing over. So, totally 4 subjects had SAE after receiving the TENEX procedure.\n\nProcedure Description:\n\nTenex: Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis Local anesthetic: Only local anesthetic into the coracohumeral ligament for adhesive capsulitis", 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 1, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Local Anesthetic First Then Tenex Plus Local Anesthetic', 'description': 'Only Local anesthetic injected into the CHL. This arm had the option to cross over into Tenex arm at 1 month.\n\nThere were 16 subjects enrolled to Local Anesthetic group. 9 Subjects crossed over into TENEX group at the one month follow-up.\n\nSo after 1 month follow-up, Only 7 Subjects remained in Local Anesthetic group and these 7 subjects did not have any SAE.\n\n3 out of 9 crossed over subjects had SAE after crossing over.\n\nProcedure Description:\n\nLocal anesthetic: Only local anesthetic into the coracohumeral ligament for adhesive capsulitis', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Shoulder Trauma', 'notes': 'Shoulder trauma which was not related to study procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Serious Adverse Event', 'notes': 'Subject underwent the reverse shoulder arthroplasty on the effected (study) site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comparison of Range of Motion of the Shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenex Plus Local Anesthetic Alone', 'description': 'Use of the TENEX device for sectioning of the CHL\n\nProcedure Description:\n\nTenex: Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis\n\nLocal anesthetic: Local anesthetic into the coracohumeral ligament for adhesive capsulitis'}, {'id': 'OG001', 'title': 'Local Anesthetic First Then Tenex Plus Local Anesthetic', 'description': 'Only Local anesthetic injected into the CHL. Patients in this arm had the option to cross over into Tenex plus Local Anesthetic arm at 1 month (\\~4 weeks).\n\nProcedure Description:\n\nLocal anesthetic: Local anesthetic into the coracohumeral ligament for adhesive capsulitis\n\nTenex: Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis'}], 'classes': [{'title': 'External Rotation', 'categories': [{'measurements': [{'value': '61', 'spread': '18', 'groupId': 'OG000'}, {'value': '49', 'spread': '16', 'groupId': 'OG001'}]}]}, {'title': 'Abduction', 'categories': [{'measurements': [{'value': '80', 'spread': '14', 'groupId': 'OG000'}, {'value': '64', 'spread': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following procedure, up to 60 minutes', 'description': 'Change in shoulder range of motion (ROM) (external rotation and abduction) procedure by at least 100%, measured with goniometer. Increased degrees of motion is indicative of more favorable/better outcomes.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Durability of Local Anesthetic - Change in Range Of Motion (ROM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Local Anesthetic First Then Tenex Plus Local Anesthetic', 'description': 'Only Local anesthetic injected into the CHL. Patients in this arm had the option to cross over into Tenex plus Local Anesthetic arm at 1 month (\\~4 weeks).\n\nProcedure Description:\n\nLocal anesthetic: Local anesthetic into the coracohumeral ligament for adhesive capsulitis\n\nTenex: Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis'}], 'classes': [{'title': 'External Rotation at Baseline (Before the procedure)', 'categories': [{'measurements': [{'value': '29', 'spread': '8', 'groupId': 'OG000'}]}]}, {'title': 'External Rotation at 1-Month', 'categories': [{'measurements': [{'value': '32', 'spread': '7', 'groupId': 'OG000'}]}]}, {'title': 'Abduction at Baseline (Before the procedure)', 'categories': [{'measurements': [{'value': '53', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': 'Abduction at 1-Month', 'categories': [{'measurements': [{'value': '57', 'spread': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Before the procedure) and at 1 month', 'description': 'Shoulder abduction and external rotation measured with goniometer. Increased degrees of motion is indicative of more favorable/better outcomes.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Durability of the TENEX - Change in Range Of Motion (ROM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenex Plus Local Anesthetic Alone', 'description': 'Use of the TENEX device for sectioning of the CHL\n\nProcedure Description:\n\nTenex: Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis\n\nLocal anesthetic: Local anesthetic into the coracohumeral ligament for adhesive capsulitis'}], 'classes': [{'title': 'External Rotation Immediately after the procedure', 'categories': [{'measurements': [{'value': '63', 'spread': '17', 'groupId': 'OG000'}]}]}, {'title': 'External Rotation in the long term', 'categories': [{'measurements': [{'value': '62', 'spread': '18', 'groupId': 'OG000'}]}]}, {'title': 'Abduction Immediately after the procedure', 'categories': [{'measurements': [{'value': '78', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': 'Abduction in the long term', 'categories': [{'measurements': [{'value': '77', 'spread': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after the procedure and at the long term follow-up (10 months to 2 years)', 'description': 'Shoulder abduction and external rotation measured with goniometer. Increased degrees of motion is indicative of more favorable/better outcomes.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In addition to 26 subjects in the TENEX group, 9 Subjects in Control group were crossed over into the TENEX arm at their 1-month visit.'}, {'type': 'SECONDARY', 'title': 'Change of Pain Intensity Score for Local Anesthetic Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Local Anesthetic First Then Tenex Plus Local Anesthetic', 'description': 'Only Local anesthetic injected into the CHL. Patients in this arm had the option to cross over into Tenex plus Local Anesthetic arm at 1 month (\\~4 weeks).\n\nProcedure Description:\n\nLocal anesthetic: Local anesthetic into the coracohumeral ligament for adhesive capsulitis\n\nTenex: Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis'}], 'classes': [{'title': 'VAS at baseline', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '8'}]}]}, {'title': 'VAS at 1-month', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '7.75', 'upperLimit': '8.25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at the Baseline visit (Before the procedure) and at the 1-month visit', 'description': 'Measured by visual analog scale (VAS). VAS is a validated, subjective measure for for acute and chronic pain. Range of possible values: 0-10. (Higher score indicates more pain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change of Pain Intensity Score for TENEX Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenex Plus Local Anesthetic Alone', 'description': 'Use of the TENEX device for sectioning of the CHL\n\nProcedure Description:\n\nTenex: Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis\n\nLocal anesthetic: Local anesthetic into the coracohumeral ligament for adhesive capsulitis'}], 'classes': [{'title': 'VAS at baseline', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '9'}]}]}, {'title': 'VAS at long term (10 months to 2 years)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at the Baseline visit (before the procedure) and at the long-term follow-up (10 months to 2 years)', 'description': 'Measured by visual analog scale (VAS). VAS is a validated, subjective measure for for acute and chronic pain. Range of possible values: 0-10. (Higher score indicates more pain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'In addition to 26 subjects in the TENEX group, 9 Subjects in Control group were crossed over into the TENEX arm at their 1-month visit.'}, {'type': 'SECONDARY', 'title': 'Change of the Oxford Shoulder Score for Local Anesthetic Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Local Anesthetic First Then Tenex Plus Local Anesthetic', 'description': 'Only Local anesthetic injected into the CHL. Patients in this arm had the option to cross over into Tenex plus Local Anesthetic arm at 1 month (\\~4 weeks).\n\nProcedure Description:\n\nLocal anesthetic: Local anesthetic into the coracohumeral ligament for adhesive capsulitis\n\nTenex: Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis'}], 'classes': [{'title': 'at the baseline', 'categories': [{'measurements': [{'value': '10.8', 'spread': '7.9', 'groupId': 'OG000'}]}]}, {'title': 'at the 1-month', 'categories': [{'measurements': [{'value': '13.8', 'spread': '8.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at the baseline (before the procedure) and at the 1-month visit', 'description': 'Measured by The Oxford Shoulder Score (OSS) questionnaire form. The Oxford Shoulder Score (OSS) is a 12-item patient-report questionnaire with a 0-4 scoring format, developed to identify functional changes of the shoulder. Range of possible values: 0-48. (Higher score represents a better outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change of the Oxford Shoulder Score for TENEX Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenex Plus Local Anesthetic Alone', 'description': 'Use of the TENEX device for sectioning of the CHL\n\nProcedure Description:\n\nTenex: Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis\n\nLocal anesthetic: Local anesthetic into the coracohumeral ligament for adhesive capsulitis'}], 'classes': [{'title': 'at the baseline', 'categories': [{'measurements': [{'value': '7.4', 'spread': '4.6', 'groupId': 'OG000'}]}]}, {'title': 'at the long term (10 months to 2 years)', 'categories': [{'measurements': [{'value': '31.8', 'spread': '11.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at the baseline (before the procedure) and at the long term follow-up (10 months to 2 years)', 'description': 'Measured by The Oxford Shoulder Score (OSS) questionnaire form. The Oxford Shoulder Score (OSS) is a 12-item patient-report questionnaire with a 0-4 scoring format, developed to identify functional changes of the shoulder. Range of possible values: 0-48. (Higher score represents a better outcome)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In addition to 26 subjects in the TENEX group, 9 Subjects in Control group were crossed over into the TENEX arm at their 1-month visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Local Anesthetic First Then Tenex Plus Local Anesthetic', 'description': 'Local anesthetic injected into the CHL. Patients in this arm also had the option to cross over into Tenex plus Local Anesthetic arm at 1 month (\\~4 weeks).\n\nProcedure Description:\n\nLocal anesthetic: Local anesthetic into the coracohumeral ligament for adhesive capsulitis\n\nTenex: Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis'}, {'id': 'FG001', 'title': 'Tenex Plus Local Anesthetic Alone', 'description': 'Use of the TENEX device for sectioning of the CHL\n\nProcedure Description:\n\nTenex: Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis\n\nLocal anesthetic: Local anesthetic into the coracohumeral ligament for adhesive capsulitis'}], 'periods': [{'title': 'First Intervention (4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Follow-up Duration was one month for local anesthetic group. All 16 Subjects completed their one month follow-up period without any adverse events.\n\n9 out of 16 subjects crossed over into TENEX group after their one-month follow-up.\n\nRemaining 7 subjects monitored only for adverse events.', 'groupId': 'FG000', 'numSubjects': '16'}, {'comment': 'Follow-up Duration was one year for TENEX group.\n\nAll 30 Subjects completed their one month follow-up period and continued to be monitored for one year.', 'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Optional Second Intervention (11 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '9 of 16 subjects crossed over into TENEX group after their one-month follow-up. Remaining 7 subjects only monitored for adverse events. Of these 7 subject, 5 had Adverse Events (4 SAEs and 1 AE) and 2 were lost to follow up', 'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tenex Plus Local Anesthetic Alone', 'description': 'Use of the TENEX device for sectioning of the CHL\n\nProcedure Description:\n\nTenex: Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis\n\nLocal anesthetic: Local anesthetic into the coracohumeral ligament for adhesive capsulitis'}, {'id': 'BG001', 'title': 'Local Anesthetic First Then Tenex Plus Local Anesthetic', 'description': 'Only Local anesthetic injected into the CHL. Patients in this arm had the option to cross over into Tenex plus Local Anesthetic arm at 1 month (\\~4 weeks).\n\nProcedure Description:\n\nLocal anesthetic: Local anesthetic into the coracohumeral ligament for adhesive capsulitis\n\nTenex: Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '65.00', 'spread': '11.59', 'groupId': 'BG000'}, {'value': '56.00', 'spread': '11.93', 'groupId': 'BG001'}, {'value': '62.21', 'spread': '11.37', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], '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': '26', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36.34', 'spread': '6.88', 'groupId': 'BG000'}, {'value': '30.45', 'spread': '5.78', 'groupId': 'BG001'}, {'value': '32.18', 'spread': '6.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Affected Arm (Right/Left)', 'classes': [{'title': 'Left Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Right Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The affected arm (Ieft or right) of each patient is noted.', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-13', 'size': 697914, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2024-02-14T11:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-24', 'studyFirstSubmitDate': '2020-09-09', 'resultsFirstSubmitDate': '2024-02-16', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-24', 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Range of Motion of the Shoulder', 'timeFrame': 'Immediately following procedure, up to 60 minutes', 'description': 'Change in shoulder range of motion (ROM) (external rotation and abduction) procedure by at least 100%, measured with goniometer. Increased degrees of motion is indicative of more favorable/better outcomes.'}], 'secondaryOutcomes': [{'measure': 'Durability of Local Anesthetic - Change in Range Of Motion (ROM)', 'timeFrame': 'Baseline (Before the procedure) and at 1 month', 'description': 'Shoulder abduction and external rotation measured with goniometer. Increased degrees of motion is indicative of more favorable/better outcomes.'}, {'measure': 'Durability of the TENEX - Change in Range Of Motion (ROM)', 'timeFrame': 'Immediately after the procedure and at the long term follow-up (10 months to 2 years)', 'description': 'Shoulder abduction and external rotation measured with goniometer. Increased degrees of motion is indicative of more favorable/better outcomes.'}, {'measure': 'Change of Pain Intensity Score for Local Anesthetic Group', 'timeFrame': 'at the Baseline visit (Before the procedure) and at the 1-month visit', 'description': 'Measured by visual analog scale (VAS). VAS is a validated, subjective measure for for acute and chronic pain. Range of possible values: 0-10. (Higher score indicates more pain)'}, {'measure': 'Change of Pain Intensity Score for TENEX Group', 'timeFrame': 'at the Baseline visit (before the procedure) and at the long-term follow-up (10 months to 2 years)', 'description': 'Measured by visual analog scale (VAS). VAS is a validated, subjective measure for for acute and chronic pain. Range of possible values: 0-10. (Higher score indicates more pain)'}, {'measure': 'Change of the Oxford Shoulder Score for Local Anesthetic Group', 'timeFrame': 'at the baseline (before the procedure) and at the 1-month visit', 'description': 'Measured by The Oxford Shoulder Score (OSS) questionnaire form. The Oxford Shoulder Score (OSS) is a 12-item patient-report questionnaire with a 0-4 scoring format, developed to identify functional changes of the shoulder. Range of possible values: 0-48. (Higher score represents a better outcome)'}, {'measure': 'Change of the Oxford Shoulder Score for TENEX Group', 'timeFrame': 'at the baseline (before the procedure) and at the long term follow-up (10 months to 2 years)', 'description': 'Measured by The Oxford Shoulder Score (OSS) questionnaire form. The Oxford Shoulder Score (OSS) is a 12-item patient-report questionnaire with a 0-4 scoring format, developed to identify functional changes of the shoulder. Range of possible values: 0-48. (Higher score represents a better outcome)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Adhesive Capsulitis']}, 'referencesModule': {'references': [{'pmid': '26323030', 'type': 'BACKGROUND', 'citation': 'Wu CH, Chen WS, Wang TG. Elasticity of the Coracohumeral Ligament in Patients with Adhesive Capsulitis of the Shoulder. Radiology. 2016 Feb;278(2):458-64. doi: 10.1148/radiol.2015150888. Epub 2015 Aug 31.'}, {'pmid': '15358849', 'type': 'BACKGROUND', 'citation': 'Mengiardi B, Pfirrmann CW, Gerber C, Hodler J, Zanetti M. Frozen shoulder: MR arthrographic findings. Radiology. 2004 Nov;233(2):486-92. doi: 10.1148/radiol.2332031219. Epub 2004 Sep 9.'}, {'pmid': '16356983', 'type': 'BACKGROUND', 'citation': 'Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.'}, {'pmid': '28405218', 'type': 'BACKGROUND', 'citation': 'Le HV, Lee SJ, Nazarian A, Rodriguez EK. Adhesive capsulitis of the shoulder: review of pathophysiology and current clinical treatments. Shoulder Elbow. 2017 Apr;9(2):75-84. doi: 10.1177/1758573216676786. Epub 2016 Nov 7.'}, {'pmid': '22405512', 'type': 'BACKGROUND', 'citation': 'Maund E, Craig D, Suekarran S, Neilson A, Wright K, Brealey S, Dennis L, Goodchild L, Hanchard N, Rangan A, Richardson G, Robertson J, McDaid C. Management of frozen shoulder: a systematic review and cost-effectiveness analysis. Health Technol Assess. 2012;16(11):1-264. doi: 10.3310/hta16110.'}, {'pmid': '30288192', 'type': 'BACKGROUND', 'citation': 'Hagiwara Y, Sekiguchi T, Ando A, Kanazawa K, Koide M, Hamada J, Yabe Y, Yoshida S, Itoi E. Effects of Arthroscopic Coracohumeral Ligament Release on Range of Motion for Patients with Frozen Shoulder. Open Orthop J. 2018 Sep 18;12:373-379. doi: 10.2174/1874325001812010373. eCollection 2018.'}, {'pmid': '29567320', 'type': 'BACKGROUND', 'citation': 'Yukata K, Goto T, Sakai T, Fujii H, Hamawaki J, Yasui N. Ultrasound-guided coracohumeral ligament release. Orthop Traumatol Surg Res. 2018 Oct;104(6):823-827. doi: 10.1016/j.otsr.2018.01.016. Epub 2018 Mar 19.'}, {'pmid': '17519989', 'type': 'BACKGROUND', 'citation': 'Austgulen OK, Oyen J, Hegna J, Solheim E. [Arthroscopic capsular release in treatment of primary frozen shoulder]. Tidsskr Nor Laegeforen. 2007 May 17;127(10):1356-8. Norwegian.'}, {'pmid': '12355929', 'type': 'BACKGROUND', 'citation': 'Chen SK, Chien SH, Fu YC, Huang PJ, Chou PH. Idiopathic frozen shoulder treated by arthroscopic brisement. Kaohsiung J Med Sci. 2002 Jun;18(6):289-94.'}, {'pmid': '28842108', 'type': 'BACKGROUND', 'citation': 'Sanchez PJ, Grady JF, Saxena A. Percutaneous Ultrasonic Tenotomy for Achilles Tendinopathy Is a Surgical Procedure With Similar Complications. J Foot Ankle Surg. 2017 Sep-Oct;56(5):982-984. doi: 10.1053/j.jfas.2017.06.015.'}, {'pmid': '25986341', 'type': 'BACKGROUND', 'citation': 'Kamineni S, Butterfield T, Sinai A. Percutaneous ultrasonic debridement of tendinopathy-a pilot Achilles rabbit model. J Orthop Surg Res. 2015 May 20;10:70. doi: 10.1186/s13018-015-0207-7.'}, {'pmid': '30280399', 'type': 'BACKGROUND', 'citation': 'Chimenti RL, Stover DW, Fick BS, Hall MM. Percutaneous Ultrasonic Tenotomy Reduces Insertional Achilles Tendinopathy Pain With High Patient Satisfaction and a Low Complication Rate. J Ultrasound Med. 2019 Jun;38(6):1629-1635. doi: 10.1002/jum.14835. Epub 2018 Oct 2.'}, {'pmid': '25306494', 'type': 'BACKGROUND', 'citation': 'Barnes DE, Beckley JM, Smith J. Percutaneous ultrasonic tenotomy for chronic elbow tendinosis: a prospective study. J Shoulder Elbow Surg. 2015 Jan;24(1):67-73. doi: 10.1016/j.jse.2014.07.017. Epub 2014 Oct 8.'}, {'pmid': '23302261', 'type': 'BACKGROUND', 'citation': 'Koh JS, Mohan PC, Howe TS, Lee BP, Chia SL, Yang Z, Morrey BF. Fasciotomy and surgical tenotomy for recalcitrant lateral elbow tendinopathy: early clinical experience with a novel device for minimally invasive percutaneous microresection. Am J Sports Med. 2013 Mar;41(3):636-44. doi: 10.1177/0363546512470625. Epub 2013 Jan 9.'}, {'pmid': '18791678', 'type': 'BACKGROUND', 'citation': 'Zhu J, Hu B, Xing C, Li J. Ultrasound-guided, minimally invasive, percutaneous needle puncture treatment for tennis elbow. Adv Ther. 2008 Oct;25(10):1031-6. doi: 10.1007/s12325-008-0099-6.'}, {'pmid': '16724200', 'type': 'BACKGROUND', 'citation': 'Homsi C, Bordalo-Rodrigues M, da Silva JJ, Stump XM. Ultrasound in adhesive capsulitis of the shoulder: is assessment of the coracohumeral ligament a valuable diagnostic tool? Skeletal Radiol. 2006 Sep;35(9):673-8. doi: 10.1007/s00256-006-0136-y. Epub 2006 May 25.'}]}, 'descriptionModule': {'briefSummary': 'Percutaneous Interruption of the Coracohumeral Ligament for the treatment of Frozen Shoulder.', 'detailedDescription': 'Chronic inflammation of the shoulder joint capsule and its associated structures can lead to clinically significant symptoms, including insidious onset of pain, and ultimately restricting range of motion. Although the underlying mechanism for adhesive capsulitis (AC) is not well defined, some studies suggest that fibroblast proliferation and thickening of the coracohumeral ligament (CHL) is a proposed mechanism for which AC and subsequent prolonged immobilization and symptoms present (1, 2, 3). Other studies suggest that it is due to a combination of capsular fibrosis and inflammation within the synovium, and other focus on the fact that thickening of the CHL is responsible for limiting external rotation in patients affected by adhesive capsulitis (1).\n\nAC coined frozen shoulder by Codman in 1934 \\[2), has an estimated prevalence of 2-3% in the general population, with ages 40-70 affected most commonly, and predominantly women. While the precise etiology remains undefined, it can be secondary to trauma or an idiopathic etiology and has been found to have an incidence as high as 20% in diabetic patients, with worse functional outcomes when compared to non-diabetic patients. Hypothyroidism and cerebrovascular disease have also been shown to be associated with an increased risk of developing AC (4). AC is typically a clinical diagnosis. However, both magnetic resonance and ultrasonography have consistently shown thickening of the CHL (1). Several studies have compared arthrographic evidence of findings in adhesive capsulitis, and many reported a thickening of the CHL in cases of frozen shoulder as compared to control subjects (2). In a study implementing shear-wave elastography (SWE), the CHL in patients diagnosed with adhesive capsulitis was thicker and stiffer (4).\n\nInterventions aimed at improving AC and CHL damage, clinical symptomatology, as well as histopathological findings range from rest and physical therapy, local injections and hydrodilation, to advanced surgical interventions (4, 5). These surgical options include manipulation under anesthesia (MUA) and arthroscopic capsulotomy. MUA is an aggressive mobilization of the joint in an effort to lyse adhesions and to stretch the contracted glenohumeral capsule. Despite potential benefits, MUA has been associated with superior labral anterior and posterior (SLAP) lesions, bankart lesions, capsular tears, hemarthrosis, and even humeral or glenoid fractures (4). Arthroscopic capsulotomy allows for direct visualization of the CHL and confirmation of the diagnosis of AC, and several studies have shown improvement in pain relief as well as range of motion (4). However, patients who did not benefit from this intervention were women, typically over the age of 50, with a past medical history of diabetes mellitus. CHL resection has also been described as a potential treatment option for AC (6, 7), with current therapy limited to a surgical approach. Management of refractory disease through arthroscopic capsular release has been shown to improve pain and increase range-of-motion (8, 9, 4). A sequela of arthroscopic surgery is postoperative persistent AC, which some surgeons attempt to prophylactically prevent with adequate postoperative pain control so that the patient can participate in a physical therapy program. The potential limitations of current conservative management and IRB NUMBER: 2020-11998 IRB APPROVAL DATE: 11/17/2020 sequelae of surgical approaches have prompted additional novel therapies. International have researchers developed an ultrasound guided technique with a scalpel incision of the CHL to address this need. Scalpel use is not the standard of care for interventional musculoskeletal pain treatments and our team decided to improve this limitation. Blades and scalpels limit US visibility, thus marginalizing the safety of the procedure. Our team used a percutaneous, ultrasound visible, needle shaped, tissue cutting device to lesion the CHL while improving upon the potential safety concerns. The tool, TENEX®, is widely used by Pain physicians to perform percutaneous tenotomies and has been described in the management of various tendinous pathologies (10, 11, 12, 13, 14, 15).; this device was selected because the gross architectural similarities of tendon and ligament suggest that the CHL could be modified by this tool. Our novel procedure was performed on cadavers to provide proof of concept\n\nThe authors performed cadaveric dissection in 8 cadaveric shoulders with the hypothesis that sonographically guided percutaneous dissection will result in sectioning of the coracohumeral ligament. In this study we found that complete sectioning was reproducibly achieved in 7 minutes with approximately 250 passes of the device. This was the desired outcome for improving the shoulder ROM (16). This shows proof of concept and we want to perform this procedure in living subjects for validation. If the results are positive patients can have an outpatient procedure in the interventional pain clinic with desirable results. This cadaveric technique study has already been submitted to Pain Medicine journal for publication.\n\nIn addition to the above proof of concept above this procedure was performed in living subjects. A peer reviewed paper was submitted based on data from these subjects. 7 patients were selected for the publication as these patients had follow-ups as requested by the reviewer. In these patients the average improvement in external rotation was 40 degrees and the average abduction improvement was 31 degrees. All patients retained this improvement in shoulder ROM at follow-up visits. Of note, one patients follow-up visit was 116 after the procedure and her improvement in ROM was 60 and 110 in external rotation and abduction respectively. Given these outcomes the authors decided to do a prospective RCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Established Diagnosis of Adhesive capsulitis (AC) Ligament Flavum \\>3mm, diagnosed by US evaluation decreased shoulder ROM in external rotation and abduction (50% of unaffected side)\n* Patients who have tried other conventional therapies like steroid treatments, surgical treatments, physiotherapy with little (defined by less than 20 degrees improvement in shoulder ROM - external rotation) to no improvement in the shoulder ROM\n\nExclusion Criteria:\n\n* Age less than 18 years and greater than 89 years\n* Patients with AC but showing improvement in shoulder ROM progressively (defined by improvement in ROM \\> 200 external rotation or 20 degrees per week when undergoing physiotherapy)\n* Patients who are currently pregnant'}, 'identificationModule': {'nctId': 'NCT04549051', 'acronym': 'CHLTenex', 'briefTitle': 'Percutaneous Interruption of the Coracohumeral Ligament for the Treatment of Frozen Shoulder', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'Percutaneous Interruption of the Coracohumeral Ligament for the Treatment of Frozen Shoulder.', 'orgStudyIdInfo': {'id': '2020-11998'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tenex plus local anesthetic', 'description': 'Use of the TENEX device for sectioning of the CHL', 'interventionNames': ['Device: Tenex', 'Drug: Local anesthetic']}, {'type': 'OTHER', 'label': 'Local Anesthetic', 'description': 'Only Local anesthetic will be injected into the CHL. This arm will have the option to cross over into Tenex arm at 1 month', 'interventionNames': ['Drug: Local anesthetic']}], 'interventions': [{'name': 'Tenex', 'type': 'DEVICE', 'description': 'Local anesthetic plus Tenex into the coracohumeral ligament for adhesive capsulitis', 'armGroupLabels': ['Tenex plus local anesthetic']}, {'name': 'Local anesthetic', 'type': 'DRUG', 'description': 'Only local anesthetic into the coracohumeral ligament for adhesive capsulitis', 'armGroupLabels': ['Local Anesthetic', 'Tenex plus local anesthetic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Sayed Wahezi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}