{ "FullStudy":{ "Rank":217660, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518504", "OrgStudyIdInfo":{ "OrgStudyId":"11-16286" }, "Organization":{ "OrgFullName":"Creighton University", "OrgClass":"OTHER" }, "BriefTitle":"Effects of Thoracic Mobilization on Shoulder Range of Motion", "OfficialTitle":"Effects of Thoracic Mobilization on Shoulder Range of Motion" }, "StatusModule":{ "StatusVerifiedDate":"November 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 1, 2011", "StudyFirstSubmitQCDate":"January 25, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 19, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"November 21, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Creighton University", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to investigate the effect of thoracic spine joint manipulation versus a sham intervention on active and passive shoulder flexion (elevation), external rotation, and internal rotation range of motion.", "DetailedDescription":"Many individuals who have a primary complaint of shoulder pain often demonstrate deficits in glenohumeral and scapulothoracic mobility. Typically individuals will have limitations in shoulder range of motion, specifically, flexion (elevation) as well as external and internal rotation. Although the glenohumeral joint is the primary joint for shoulder motion adjacent joints such as the sternoclavicular, acromioclavicular, scapulothoracic, and thoracic spine also contribute to maximal shoulder motion. Limited shoulder motion may be a result of joint hypomobility, muscle inhibition, or pain. Typically interventions such as stretching and joint mobilization/manipulation are directed at the glenohumeral joint to improve shoulder motion, but little is known about interventions targeting adjacent sites which may also improve shoulder range of motion. This study will evaluate the effect of thoracic spine joint manipulation on active and passive shoulder range of motion." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Shoulder Range of Motion in Healthy Individuals" ] }, "KeywordList":{ "Keyword":[ "Thoracic", "Manipulation", "Manual Therapy", "Mobilization", "Shoulder", "Range of Motion" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"40", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Thoracic Mobilization", "ArmGroupType":"Experimental", "ArmGroupDescription":"The subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will apply a small amplitude, quick thrust at end of range.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Thoracic Mobilization" ] } },{ "ArmGroupLabel":"Sham", "ArmGroupType":"Sham Comparator", "ArmGroupDescription":"The subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will not apply any other force than light hand contact.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Sham" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"Thoracic Mobilization", "InterventionDescription":"The subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will apply a small amplitude, quick thrust at end of range.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Thoracic Mobilization" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "manipulation", "Grade V joint mobilization", "small amplitude, quick thrust mobilization/manipulation" ] } },{ "InterventionType":"Other", "InterventionName":"Sham", "InterventionDescription":"The subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will not apply any other force than light hand contact.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Sham" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Changes in Shoulder Range of motion", "PrimaryOutcomeDescription":"To determine changes in shoulder active and passive range of motion following one of two intervention protocols. Changes will be measured by examining shoulder range of motion in three directions: Shoulder flexion, internal rotation and external rotation.\n\nWe hypothesize that the use of a thoracic spine joint manipulation will increase shoulder range of motion in flexion (elevation) as well as external and internal rotation to a greater degree than a sham mobilization.", "PrimaryOutcomeTimeFrame":"Single Study Visit" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAdults 19-45 years\n\nExclusion Criteria:\n\nIndividuals who are pregnant\nHistory of cervical or thoracic surgery\nBone or joint disease\nCurrent infection or tumor\nOsteopenia/osteoporosis\nSpinal fracture\nRheumatologic pathologies", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"19 Years", "MaximumAge":"45 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Terry L Grindstaff, PHD,PT,ATC", "OverallOfficialAffiliation":"Creighton University", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Creighton University", "LocationCity":"Omaha", "LocationState":"Nebraska", "LocationZip":"68178", "LocationCountry":"United States" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" } } } } }