Ignite Creation Date:
2024-07-17 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474429
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Brief Title:
Assessing the Functional Movement Screen as a Reliable Physical Therapy Discharge Criteria for Chronic Lower Back Pain Patients
Sponsor:
Texas Back Institute
Organization:
Texas Back Institute
Study Overview
Official Title:
Assessing the Functional Movement Screen as a Reliable Physical Therapy Discharge Criteria for Chronic Lower Back Pain Patients
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Overview of Research Design and Objectives
This 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
Specific Aims and Hypotheses
The study specifically aims to
Assess the effectiveness of FMS in determining discharge readiness for chronic LBP patients
The hypothesis is that a specific threshold score on the FMS can reliably indicate a patient39s readiness for discharge reducing the risk of recurrence and ensuring better long-term functional outcomes
Rationale for the Study
Chronic 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
Procedures
The 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
Risks and Anticipated Benefits
Risks 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 study39s 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 participant39s involvement at any point for safety reasons
Outcomes
The study will report on the average FMS score correlating with discharge readiness and the variance in scores across different functional assessments
Statistical Analysis
Data will be analyzed using descriptive statistics correlation analysis and repeated measures ANOVA or Friedman Test with a significance level set at α005
Completion Time
The study is expected to complete enrollment within two years
Abbreviations and Terms
LBP 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
This 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
Specific Aims and Hypotheses
The study specifically aims to
Assess the effectiveness of FMS in determining discharge readiness for chronic LBP patients
The hypothesis is that a specific threshold score on the FMS can reliably indicate a patient39s readiness for discharge reducing the risk of recurrence and ensuring better long-term functional outcomes
Rationale for the Study
Chronic 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
Procedures
The 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
Risks and Anticipated Benefits
Risks 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 study39s 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 participant39s involvement at any point for safety reasons
Outcomes
The study will report on the average FMS score correlating with discharge readiness and the variance in scores across different functional assessments
Statistical Analysis
Data will be analyzed using descriptive statistics correlation analysis and repeated measures ANOVA or Friedman Test with a significance level set at α005
Completion Time
The study is expected to complete enrollment within two years
Abbreviations and Terms
LBP 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None