[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557284":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":57,"collaborators":59,"id":68,"slug":26,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":92,"whyStopped":26,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"United States Naval Medical Center, San Diego","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Criteria-based Rehabilitation for Injured Shoulders Paradigm (CRISP).","EXPERIMENTAL","The CRISP group will undergo physical therapy treatment, directed by a research physical therapist, including both supervised physical therapy and a guided home exercise program.",[13],"Other: CRISP: Criteria-Based Approach for the Rehabilitation for Non-Operative Shoulder Injuries",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","ACTIVE_COMPARATOR","The standard of care group will serve as the control arm and complete a period of physical rehabilitation under the supervision of a Military Health System physical therapist without study-specific guidance or interventions.",[19],"Other: Standard of Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"OTHER","CRISP: Criteria-Based Approach for the Rehabilitation for Non-Operative Shoulder Injuries","The CRISP group will undergo physical therapy treatment, directed by a research physical therapist, including both supervised physical therapy and a guided home exercise program. This approach has three phases: stabilization, to facilitate joint protection; strength and endurance, to optimize functional capacity; and power, to prepare the Service member for returning to previous level of duty.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"The Standard of Care group will serve as the control arm and complete a period of physical rehabilitation under the supervision of a Military Health System physical therapist without study-specific guidance or interventions.",[15],[31],{"name":32,"affiliation":33,"role":34},"Marisunta Pontillo, PhD","Extremity Trauma and Amputation Center of Excellence, Defense Health Agency","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","215-266-1904","marisunta.l.pontillo.civ@health.mil",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Sara Gorczynski","619-532-9704","sara.r.gorczynski.ctr@health.mil",[45],{"facility":46,"status":26,"city":47,"state":48,"zip":49,"country":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":26},"Naval Medical Center San Diego","San Diego","California","92134","United States",{"type":52,"coordinates":53},"Point",[54,55],-117.16472,32.71571,{"lat":55,"lon":54},{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[60,62,64,66],{"name":61,"class":6},"Brooke Army Medical Center",{"name":63,"class":6},"Congressionally Directed Medical Research Programs",{"name":65,"class":22},"Henry M. Jackson Foundation for the Advancement of Military Medicine",{"name":67,"class":22},"The Geneva Foundation","100557284",false,"NCT06536114","Efficacy of a Criteria Based Clinical Pathway for Rehabilitation of Shoulder Injuries","CRISP","Inclusion Criteria:\n\n* Active-duty Service members over the age of 18 who are seeking medical attention for shoulder pain or injury will be recruited to participate in this study.\n\nExclusion Criteria:\n\n* The exclusion criteria include individuals who have sustained cervical or thoracic spine injury in the past year; an upper extremity or spine injury within the past year and have not been cleared to perform their previous duty requirements; a diagnosis of adhesive capsulitis; individuals referred to post-operative rehabilitation for the shoulder; individuals who are scheduled for shoulder surgery within the following 12 weeks; pain originating from a body region other than shoulder or is non-orthopaedic in nature; individuals who have sustained an upper extremity limb loss; individuals pending a medical evaluation board, discharge from the military, or pending litigation for an injury.","ALL","18 Years","65 Years",{"count":78,"type":79},250,"ESTIMATED","INTERVENTIONAL",[82],"NA","The goal of this clinical trial is to compare the current standard of care for rehabilitation of non-operative shoulder injuries to a novel, criteria-based approach (CRISP). Additionally, this study will identify factors which contribute to return to duty readiness. The main questions it aims to answer are:\n\n* Are there differences in patient reported outcomes between participants who undergo the criteria-based rehabilitation program versus the standard of care for shoulder injuries?\n* Are there differences in clinical measures (strength, etc.) between participants who undergo the criteria-based rehabilitation program versus the standard of care for shoulder injuries?\n* Are there clinical or rehabilitation factors, or participant characteristics, that contribute to return to duty readiness?\n\nParticipants will be randomized to either complete their rehabilitation per the standard of care with a physical therapist in a Military Treatment Facility or complete the CRISP program with a research physical therapist. Participants will:\n\n* Attend physical therapy for a non-operative shoulder injury\n* Attend initial and final clinical assessments at the clinic\n* Complete patient reported outcomes at 1-, 3-, 6- and 12-month timepoints",[85,86],"Shoulder Pain","Shoulder Injuries",[88,89,90,91],"shoulder","return-to-duty","physical therapy","rehabilitation","NOT_YET_RECRUITING","2024-07-31",{"date":95,"type":96},"2024-08-02","ACTUAL",{"date":98,"type":79},"2025-03-01",{"date":100,"type":79},"2027-08-30",{"name":5,"class":6},1]