Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-31 @ 6:45 PM
Study NCT ID:
NCT01606332
Status:
UNKNOWN
Last Update Posted:
2013-06-11
First Post:
2012-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-10', 'studyFirstSubmitDate': '2012-05-23', 'studyFirstSubmitQcDate': '2012-05-24', 'lastUpdatePostDateStruct': {'date': '2013-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in shoulder function as demonstrated by increased range of motion', 'timeFrame': '10 days, 4, 8, 16 weeks and 6 months', 'description': 'The primary outcome measure will be an improvement in shoulder function as measured by the ASES shoulder score.'}], 'secondaryOutcomes': [{'measure': 'Decrease in shoulder pain', 'timeFrame': '10 days, 4, 8, 16 weeks and 6 months', 'description': 'The secondary outcome measure will be a reduction in shoulder pain as measured by the VAS pain score.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Frozen Shoulder']}, 'descriptionModule': {'briefSummary': 'In patients who undergo shoulder manipulation for idiopathic adhesive capsulitis, a postoperative indwelling analgesic pain catheter will improve patient outcomes by decreasing shoulder pain and improving range of motion compared to a single-dose interscalene block.', 'detailedDescription': "Shoulder manipulation under anesthesia to treat idiopathic adhesive capsulitis is performed only when conservative treatment fails to remedy the condition.\n\nIt is common practice to use an interscalene nerve block as anesthesia for this surgical intervention. This randomized prospective study is designed to evaluate the effects of two different anesthesia methods on patient's post-surgical rehabilitation after manipulation. Forty patients scheduled for surgery will be entered into this study. Patients will be randomly assigned to receive a single-doseinterscalene block or a single-dose interscalene block and an indwelling nerve catheter which will provide a continuous infusion of local anesthetic. Patients with the continuous infusion of local anesthetic will receive the additional anesthesia for 24 hours. Patient's range of motion will be evaluated pre-op, intra-op and post-operatively at 10 days, 4,8,16 weeks and 6 months"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and Females over the age of 18 with a diagnosis of idiopathic adhesive capsulitis\n* Failed conservative treatment for a minimum of 4 months\n* Patient had 3 sequential office visits with no clinical improvement\n\nExclusion Criteria:\n\n* Adhesive capsulitis following a surgical procedure and/or fracture'}, 'identificationModule': {'nctId': 'NCT01606332', 'briefTitle': 'Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis', 'organization': {'class': 'OTHER', 'fullName': 'OAD Orthopaedics'}, 'officialTitle': 'Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis', 'orgStudyIdInfo': {'id': 'AC001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Single in interscalene block', 'description': 'Single indwelling interscalene block with ropivacaine 0.5% 10ml'}, {'type': 'EXPERIMENTAL', 'label': 'Interscalene block with nerve catheter', 'description': 'Interscalene block with ropivacaine 0.5% 10ml and placement of an indwelling nerve catheter with ropivacaine 0.2% @5ml/hr for 24 hours', 'interventionNames': ['Procedure: Interscalene block with nerve catheter']}], 'interventions': [{'name': 'Interscalene block with nerve catheter', 'type': 'PROCEDURE', 'description': 'Interscalene block with ropivacaine 0.5% 10ml and placement of an indwelling nerve catheter with ropivacaine 0.2% @5ml/hr for 24 hours', 'armGroupLabels': ['Interscalene block with nerve catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60555', 'city': 'Warrenville', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marjorie L Delaney, APN', 'role': 'CONTACT', 'email': 'marjorie.delaney@oadortho.com', 'phone': '630-225-2554'}], 'facility': 'OAD Orthopaedics', 'geoPoint': {'lat': 41.81781, 'lon': -88.1734}}], 'centralContacts': [{'name': 'Marjorie Delaney, APN', 'role': 'CONTACT', 'email': 'marjorie.delaney@oadortho.com', 'phone': '630-225-2554'}], 'overallOfficials': [{'name': 'Aaron A Bare, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OAD Orthopaedics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OAD Orthopaedics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}