Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:33 PM
Study NCT ID:
NCT05384093
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2022-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcomes of Treatment Using the ERMI Shoulder Flexionater ®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002062', 'term': 'Bursitis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-06-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2022-05-03', 'studyFirstSubmitQcDate': '2022-05-17', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder Range of Motion Improvement', 'timeFrame': '3 months', 'description': 'Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice'}, {'measure': 'Shoulder Range of Motion', 'timeFrame': '6 months', 'description': 'Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice'}, {'measure': 'Shoulder Range of Motion', 'timeFrame': '12 months', 'description': 'Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice'}, {'measure': 'Shoulder Range of Motion', 'timeFrame': '24 months', 'description': 'Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice'}, {'measure': 'Shoulder Range of Motion', 'timeFrame': '6 weeks', 'description': 'Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice'}, {'measure': 'Shoulder Range of Motion', 'timeFrame': 'baseline', 'description': 'Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice'}, {'measure': 'VAS (Visual Analog Scale) Pain Score', 'timeFrame': '3 months', 'description': 'Visual Analog Scale Pain Score 0 (no pain) - 10 (pain as bad as it can be)'}, {'measure': 'VAS Pain Score', 'timeFrame': '6 weeks', 'description': 'Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)'}, {'measure': 'VAS Pain Score', 'timeFrame': '6 months', 'description': 'Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)'}, {'measure': 'VAS Pain Score', 'timeFrame': '12 months', 'description': 'Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)'}, {'measure': 'VAS Pain Score', 'timeFrame': '24 months', 'description': 'Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)'}, {'measure': 'VAS Pain Score', 'timeFrame': 'baseline', 'description': 'Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)'}, {'measure': 'ASES Score', 'timeFrame': 'baseline', 'description': 'American Shoulder and Elbow Society Score (10 activities of daily living are calculated)'}, {'measure': 'ASES Score', 'timeFrame': '3 month', 'description': 'American Shoulder and Elbow Society Score (10 activities of daily living are calculated)'}, {'measure': 'ASES Score', 'timeFrame': '6 weeks', 'description': 'American Shoulder and Elbow Society Score (10 activities of daily living are calculated)'}, {'measure': 'ASES Score', 'timeFrame': '6 months', 'description': 'American Shoulder and Elbow Society Score (10 activities of daily living are calculated)'}, {'measure': 'ASES Score', 'timeFrame': '12 months', 'description': 'American Shoulder and Elbow Society Score (10 activities of daily living are calculated)'}, {'measure': 'ASES Score', 'timeFrame': '24 months', 'description': 'American Shoulder and Elbow Society Score (10 activities of daily living are calculated)'}], 'secondaryOutcomes': [{'measure': 'SST', 'timeFrame': 'Baseline', 'description': 'Simple Shoulder Test'}, {'measure': 'SST', 'timeFrame': '3 month', 'description': 'Simple Shoulder Test'}, {'measure': 'SST', 'timeFrame': '6 weeks', 'description': 'Simple Shoulder Test'}, {'measure': 'SST', 'timeFrame': '6 months', 'description': 'Simple Shoulder Test'}, {'measure': 'SST', 'timeFrame': '12 months', 'description': 'Simple Shoulder Test'}, {'measure': 'SST', 'timeFrame': '24 months', 'description': 'Simple Shoulder Test'}, {'measure': 'Device Compliance Questionnaire (if applicable)', 'timeFrame': '6 weeks', 'description': 'compliance with Device usage'}, {'measure': 'Device Compliance Questionnaire (if applicable)', 'timeFrame': '3 months', 'description': 'compliance with Device usage'}, {'measure': 'Device Compliance Questionnaire (if applicable)', 'timeFrame': '6 months', 'description': 'compliance with Device usage'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Adhesive Capsulitis of Shoulder']}, 'referencesModule': {'references': [{'pmid': '38643086', 'type': 'DERIVED', 'citation': 'Teytelbaum DE, Kumar NS, Dent CS, Neaville S, Warren DH, Simon P, Baker CE. Efficacy of a high-intensity home stretching device and traditional physical therapy in non-operative management of adhesive capsulitis - a prospective, randomized control trial. BMC Musculoskelet Disord. 2024 Apr 20;25(1):305. doi: 10.1186/s12891-024-07448-4.'}]}, 'descriptionModule': {'briefSummary': 'Study 1 - Adhesive Capsulitis Study - 110 patients The purpose of this study is to compare treatment of patients with symptoms of adhesive capsulitis, primary and secondary, between three groups: I) Physical Therapy alone; II) ERMI Shoulder Flexionater® alone; III) PT + Device.\n\nStudy 2 - Postoperative Shoulder Stiffness Study - 90 patients The purpose of this study is to compare treatment of patients with post-operative stiffness indicative of secondary adhesive capsulitis between three groups: I) Physical Therapy alone; II) ERMI Shoulder Flexionater® alone; III) PT + Device.\n\nStudy 3 - Stiffness after MUA Study - enroll all eligible patients (goal of at least 15) The purpose of this study is to compare treatment of patients who have undergone manipulation under anesthesia or lysis of adhesions between three groups: I) Physical Therapy alone; II) ERMI Shoulder Flexionater® alone; III) PT + Device.', 'detailedDescription': 'Study 1 - Adhesive Capsulitis Study (AC)\n\nObjective: The purpose of this study is to compare treatment efficacy of patients with symptoms of primary and secondary adhesive capsulitis between three groups: 1) Patients treated with Physical Therapy alone; 2) Patients treated with the ERMI Shoulder Flexionater® alone; 3) Patients treated with PT + Device in the treatment.\n\n1. Prospective randomized control trial\n2. Sample size - 110 patients\n3. Study Groups:\n\n 1. Group I - Physical Therapy Only\n 2. Group II - Flexionater® only\n 3. Group III - Flexionater® and Physical Therapy\n4. Length of study - 2-year follow-up from last enrolled patient\n\nStudy 2 - Postoperative Shoulder Stiffness Study (POS)\n\nObjective: The purpose of this study is to compare treatment efficacy of patients with post-operative stiffness indicative of secondary adhesive capsulitis between three groups: I) Patients treated with Physical Therapy alone; II) Patients treated with the ERMI Shoulder Flexionater® alone; III) Patients treated with PT + Device in the treatment.\n\n1. Prospective randomized control trial\n2. Sample size - 90 enrolled patients\n3. Study Groups:\n\n 1. Group I - Physical Therapy only\n 2. Group II - Flexionater® only\n 3. Group III - Flexionater® and Physical Therapy\n4. Length of study - 2-year follow-up from last enrolled patient\n\nStudy 3 - Secondary Surgery Study (SAM)\n\nObjective: The purpose of this study is to compare recovery of patients who have undergone a manipulation under anesthesia or a lysis of adhesions between three groups: 1) Patients treated with Physical Therapy alone; 2) Patients treated with the ERMI Shoulder Flexionater® alone; 3) Patients treated with PT + Device in the treatment.\n\n1. Prospective randomized control trial\n2. Sample size - 10 enrolled patients\n3. Study Groups:\n\n 1. Group I Physical Therapy Only\n 2. Group II - - Flexionater® only\n 3. Group III - Flexionater® and Physical Therapy\n4. Length of study - 2-year follow-up from last enrolled patient'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For Study Group 1- Adhesive Capsulitis (AC)\n\nInclusion Criteria:\n\n* Exhibits symptoms of adhesive capsulitis i. Shoulder pain with limited motion for more than one month ii. AND ≤ 30 degrees external rotation with arm at side iii. AND ≤ 130 degrees forward flexion d. Cortisone shot for all patients\n\nExclusion Criteria:\n\n* a. No prior shoulder surgery b. Infection c. Rheumatoid arthritis d. Any structural or systemic disorder that could result in pain or ROM limitation i. Such as inflammatory joint disease, osteoarthritis evidenced on radiographs ii. full thickness rotator cuff tear as shown by ultrasound imaging iii. history of major trauma or surgery involving the shoulder\n\nFor Study Group 2 - Postoperative Shoulder Stiffness Study (POS)\n\nInclusion Criteria:\n\nc. Is not recovering normally based on objective criteria set for screening process i. Step 1 - Follow patients -all post-op patients with indicated procedures (see # 7 for list.) ii. Step 2 - Screen Patients -does patient meets inclusion criteria at 6 weeks or 3 months of follow-up?\n\n1. \\< 15 degrees external rotation with arm at side at 6 weeks post-op\n2. OR \\< 90 degrees forward flexion at 3 months post-op iii. Step 3 - Enroll patients that meet inclusion criteria and assign group\n\nExclusion Criteria:\n\na. Revision surgery b. Infection c. Rheumatoid arthritis\n\n7\\. Procedures included\n\n1. Shoulder arthroscopic procedures (29827, 29828, 29823,29824, 29826)\n2. ORIF Humerus fracture (23615)\n\n For Study Group 3, Secondary Surgery Study (SAM)\n\n Inclusion Criteria:\n3. Underwent a manipulation under anesthesia or a lysis of adhesions procedure\n\nExclusion Criteria:\n\na. Infection b. Rheumatoid arthritis c. Any structural or systemic disorder that could result in pain or ROM limitation i. Such as inflammatory joint disease, osteoarthritis evidenced on radiographs ii. full thickness rotator cuff tear as shown by ultrasound imaging iii. history of major trauma or surgery involving the shoulder\n\n7\\. Procedures included\n\n1. Manipulation under anesthesia (23700)\n2. Lysis of adhesions (29825)'}, 'identificationModule': {'nctId': 'NCT05384093', 'briefTitle': 'Outcomes of Treatment Using the ERMI Shoulder Flexionater ®', 'organization': {'class': 'OTHER', 'fullName': 'Foundation for Orthopaedic Research and Education'}, 'officialTitle': 'Outcomes of Treatment Using the ERMI Shoulder Flexionater®', 'orgStudyIdInfo': {'id': 'FORE AC 2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adhesive Capsulitis Study', 'description': 'The purpose of this study is to compare treatment efficacy of patients with symptoms of primary and secondary adhesive capsulitis between three groups: 1) Patients treated with Physical Therapy alone; 2) Patients treated with the ERMI Shoulder Flexionater® alone; 3) Patients treated with PT + Device in the treatment.', 'interventionNames': ['Device: High Intensity Stretch Device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Post operative Shoulder Stiffness Study', 'description': 'The purpose of this study is to compare treatment efficacy of patients with post-operative stiffness indicative of secondary adhesive capsulitis between three groups: I) Patients treated with Physical Therapy alone; II) Patients treated with the ERMI Shoulder Flexionater® alone; III) Patients treated with PT + Device in the treatment.', 'interventionNames': ['Device: High Intensity Stretch Device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Secondary Surgery Study', 'description': 'The purpose of this study is to compare recovery of patients who have undergone a manipulation under anesthesia or a lysis of adhesions between three groups: 1) Patients treated with Physical Therapy alone; 2) Patients treated with the ERMI Shoulder Flexionater® alone; 3) Patients treated with PT + Device in the treatment.', 'interventionNames': ['Device: High Intensity Stretch Device']}], 'interventions': [{'name': 'High Intensity Stretch Device', 'type': 'DEVICE', 'otherNames': ['Physical Therapy'], 'description': 'High Intensity Stretch and Physical Therapy are used either together or alone to treat study arm.', 'armGroupLabels': ['Adhesive Capsulitis Study', 'Post operative Shoulder Stiffness Study', 'Secondary Surgery Study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Deborah H Warren', 'role': 'CONTACT', 'email': 'dwarren@foreonline.org', 'phone': '813-978-9700', 'phoneExt': '6766'}], 'facility': 'Foundation for Orthopaedic Research and Education', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'centralContacts': [{'name': 'Deborah H Warren, RN', 'role': 'CONTACT', 'email': 'dwarren@foreonline.org', 'phone': '8139789700', 'phoneExt': '6766'}, {'name': 'Viki Sochor', 'role': 'CONTACT', 'email': 'vsochor@foreonline.org', 'phone': '813-978-9700', 'phoneExt': '6832'}], 'overallOfficials': [{'name': 'Peter Simon, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Foundation for Orthopaedic Research and Education'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'unknown at this time'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation for Orthopaedic Research and Education', 'class': 'OTHER'}, 'collaborators': [{'name': 'ERMI, LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}