Assessing the Functional Movement Screen as a Reliable Physical Therapy Discharge Criteria for Chronic Lower Back Pain Patients

NCT06474429 | Recruiting

• 1 other identifier: 2169799
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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 patient\'s 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 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. 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 α=0.05. 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®

Conditions

Chronic Lower Back Pain

Keywords

Chronic Lower Back Pain; Physical Therapy; Discharge

Outcome Measures

Primary Outcomes (1)

• Average FMS Scores

  e study will report on the average FMS score correlating with discharge readiness and the variance in scores across different functional assessments.

  From enrollment to the end of treatment at 12 weeks

Study Arms (1)

CLBP Patients

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.

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

* Non-surgical patients who have had lower back pain for \>3 months * Patients who include and are between the ages of 18 and 49 * Patients with a BMI of \<30 * Not pregnant with no plans of becoming pregnant during the duration of the study * Be able and willing to understand and sign consent for study participation * Be physically able to comply with study protocol requirements * Not have had recent surgeries or have confounding factors that would keep them from being able to perform any portion of the FMS assessment

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Texas Back Institute: lead

Study Sites (1)

Texas Back Institute

Plano, Texas, 75093, United States

RECRUITING

Study Officials

• Steven Kight, PT

  Texas Back Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara R McMahan, PhD

CONTACT

972-943-2720; sara.mcmahan@texasback.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: April 26, 2024
• Primary Completion: March 8, 2026
• Study Completion (Estimated): September 8, 2026
• Last Updated: June 25, 2024

Record last verified: 2024-03

Locations

US (1)