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NCT Number: NCT06474429

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

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®

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas Back Institute

Plano, Texas, 75093, United States

Location status: Recruiting

Location contact

Sara McMahan, PhD

SUB_INVESTIGATOR

Sara R McMahan, PhD

CONTACT

[email protected]

972-943-2720

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Primary outcomes

  1. Average FMS Scores

    Time frame: From enrollment to the end of treatment at 12 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sara R McMahan, PhD

CONTACT

[email protected]

972-943-2720

Sponsors and collaborators

Lead sponsor

Texas Back Institute

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2024
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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