[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100230929":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":41,"responsibleParty":59,"collaborators":24,"id":62,"slug":24,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":24,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":24,"enrollmentInfo":70,"targetDuration":24,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":44,"whyStopped":24,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Physical Therapy with Steroid Injection","EXPERIMENTAL","Patients will undergo regular physical therapy as defined by the standard of care at Massachusetts General Hospital for Adhesive Capsulitis (Frozen Shoulder). If they are in the inflammatory phase of the condition, they will receive 40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine.",[13,14],"Other: Physical Therapy","Drug: Depot Methylprednisolone",{"label":16,"type":10,"description":17,"interventionNames":18},"Watchful Waiting with Steroid Injection","Patients will undergo no therapeutic intervention outside of steroid injection. If they are in the inflammatory phase of the condition, they will receive 40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine.",[14],[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Physical Therapy","The following link contains the protocol for physical therapy that will be used in the study. There are no other ancillary devices or drugs used in this study aside from the depot methylprednisolone listed under interventions.\n\nBrigham and Women's\u002FMassachusetts General Standard of Care Guidelines for Physical Therapy in Treatment of Adhesive Capsulitis:\n\nhttp:\u002F\u002Fwww.brighamandwomens.org\u002FPatients\\_Visitors\u002Fpcs\u002Frehabilitationservices\u002FPhysical%20Therapy%20Standards%20of%20Care%20and%20Protocols\u002FShoulder%20-%20Adhesive%20capsulitis.pdf",[9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Depot Methylprednisolone","40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine",[9,16],[31],"Depo Medrol",[33],{"name":34,"affiliation":5,"role":35},"Scott D Martin, MD","PRINCIPAL_INVESTIGATOR",[37],{"name":34,"role":38,"phone":39,"phoneExt":24,"email":40},"CONTACT","617-732-5329","sdmartin@partners.org",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"MGH, Massachusetts General Hospital","RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-71.05977,42.35843,{"lat":54,"lon":53},[57],{"name":34,"role":38,"phone":24,"phoneExt":24,"email":58},"SDMARTIN@partners.org",{"type":35,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Scott D Martin","Associate Professor of Orthopedic Surgery","100230929",false,"NCT02283996","Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment","Inclusion Criteria:\n\n* Patient must be 18 years or older\n* Must meet the following definition for adhesive capsulitis as defined by the American Academy of Orthopedic Surgeons: Self-limiting condition resulting from any inflammatory process about the shoulder in which capsular scar tissue is produced, resulting in pain and limited range of motion; also called frozen shoulder\n* Must be amenable to randomization into either cohort\n\nExclusion Criteria:\n\n* Non-English speaking patients\n* Pregnant women (women of childbearing potential will be advised to undergo regular pregnancy testing)\n* Patients who had previously undergone operative therapy for the condition",true,"ALL","18 Years",{"count":71,"type":72},260,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","The purpose of this study is to identify individuals 18 or older who have diagnostic presentation of adhesive capsulitis and randomize them into two arms, distinguished by use of physical therapy and steroid injections compared with steroid injections followed by watchful waiting. This prospective study will be used to determine whether there is a significant impact on patient outcome and whether the additional financial burden is justified. There are no experimental interventions for this study. The use of physical therapy, oral and parenteral corticosteroids, and watchful waiting are offered following the standard of care for adhesive capsulitis. Our hypothesis is that patients will not have a significant difference in outcome between the two study arms. One group will undergo regular physical therapy with corticosteroid injections (Arm 1) and the other will have steroid injections during the inflammatory phase only and then be regularly observed (Arm 2). We also hypothesize there will be a significant financial burden associated with the PT arm that is not justified with the possibility of increased symptom reports in that arm.",[78,79,80],"Adhesive Capsulitis","Frozen Shoulder","Shoulder Frozen",[78,79,80,21,82,83,84,85,86],"Corticosteroid Injections","Hydrodilation, Hydro-dilation","Watchful Waiting","Prospective","Glenohumeral Ligament","2025-10-24",{"date":89,"type":90},"2025-10-27","ACTUAL",{"date":92,"type":90},"2014-11",{"date":94,"type":72},"2027-12",{"name":5,"class":6},1]