[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552541":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":22,"responsibleParty":41,"collaborators":10,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":10,"eligibilityCriteria":48,"healthyVolunteers":45,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":55,"studyType":56,"phases":10,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":24,"whyStopped":10,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Texas Back Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"CLBP Patients",null,"Patients who have experienced LBP for longer than three months and are undergoing physical therapy for their symptoms will be recruited from the Texas Back Institute.",[13],{"name":14,"affiliation":5,"role":15},"Steven Kight, PT","PRINCIPAL_INVESTIGATOR",[17],{"name":18,"role":19,"phone":20,"phoneExt":10,"email":21},"Sara R McMahan, PhD","CONTACT","972-943-2720","sara.mcmahan@texasback.com",[23],{"facility":5,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"RECRUITING","Plano","Texas","75093","United States","US",{"type":31,"coordinates":32},"Point",[33,34],-96.69889,33.01984,{"lat":34,"lon":33},[37,38],{"name":18,"role":19,"phone":20,"phoneExt":10,"email":21},{"name":39,"role":40,"phone":10,"phoneExt":10,"email":10},"Sara McMahan, PhD","SUB_INVESTIGATOR",{"type":42,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100552541","assessing-the-functional-movement-screen-as-a-reliable-physical-therapy-discharge-criteria-for-chronic-lower-back-pain-patients-100552541",false,"NCT06474429","Assessing the Functional Movement Screen as a Reliable Physical Therapy Discharge Criteria for Chronic Lower Back Pain Patients","* Non-surgical patients who have had lower back pain for \\>3 months\n* Patients who include and are between the ages of 18 and 49\n* Patients with a BMI of \\<30\n* Not pregnant with no plans of becoming pregnant during the duration of the study\n* Be able and willing to understand and sign consent for study participation\n* Be physically able to comply with study protocol requirements\n* Not have had recent surgeries or have confounding factors that would keep them from being able to perform any portion of the FMS assessment","ALL","18 Years","49 Years",{"count":53,"type":54},50,"ESTIMATED","6 Months","OBSERVATIONAL","Overview of Research Design and Objectives\n\nThis study is a prospective, concurrent cohort study aimed at evaluating the reliability of the Functional Movement Screen (FMS) as a discharge criterion for patients with chronic lower back pain (LBP) undergoing physical therapy. The primary objective is to identify a benchmark FMS score that correlates with a low risk of recurrence and high levels of functional performance post-discharge.\n\nSpecific Aims and Hypotheses\n\nThe study specifically aims to:\n\nAssess the effectiveness of FMS in determining discharge readiness for chronic LBP patients.\n\nThe hypothesis is that a specific threshold score on the FMS can reliably indicate a patient\\'s readiness for discharge, reducing the risk of recurrence and ensuring better long-term functional outcomes.\n\nRationale for the Study\n\nChronic LBP is a prevalent condition requiring multidisciplinary management. The FMS, widely used in athletic and military settings, has potential utility in clinical management of chronic LBP, particularly in establishing discharge criteria. This study seeks to explore this potential, addressing a gap in evidence regarding discharge benchmarks for chronic LBP patients.\n\nProcedures\n\nThe study involves 50 chronic LBP patients from the Texas Back Institute. Participants will undergo their standard physical therapy regimen, supplemented by regular FMS assessments to evaluate discharge readiness. Assessments include a series of functional tasks, with scores ranging from 0 to 3 for each task, culminating in a total possible score of 21.\n\nRisks and Anticipated Benefits\n\nRisks are minimal, akin to those in low-intensity exercises. Benefits include improved discharge criteria for chronic LBP patients, potentially enhancing long-term outcomes. All procedures adhere to Good Clinical Practice and Health Insurance Portability and Accountability Act guidelines. This study\\'s risks include potential loss of confidentiality, psychological, and physical risks. Physical risks are minimal, similar to those in low-intensity exercises like squatting and lunging. To protect confidentiality, data will be managed in compliance with Good Clinical Practice and HIPAA guidelines, with encryption and secure storage. Psychological and physical risks are mitigated through thorough instruction, practice trials, and breaks for participants. Additionally, trained study personnel can terminate a participant\\'s involvement at any point for safety reasons.\n\nOutcomes\n\nThe study will report on the average FMS score correlating with discharge readiness and the variance in scores across different functional assessments.\n\nStatistical Analysis\n\nData will be analyzed using descriptive statistics, correlation analysis, and repeated measures ANOVA or Friedman Test, with a significance level set at α=0.05.\n\nCompletion Time\n\nThe study is expected to complete enrollment within two years.\n\nAbbreviations and Terms\n\nLBP: Lower Back Pain FMS: Functional Movement Screen PROM: Patient-Reported Outcome Measures VAS: Visual Analog Scale ODI: Oswestry Disability Index ANOVA: Analysis of Variance PROMIS: Patient-Reported Outcomes Measurement Information System®",[59],"Chronic Lower Back Pain",[59,61,62],"Physical Therapy","Discharge","2024-06-19",{"date":65,"type":66},"2024-06-25","ACTUAL",{"date":68,"type":66},"2024-04-26",{"date":70,"type":54},"2026-09-08",{"name":5,"class":6},1]