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RecruitingNCT06474429Updated Jun 25, 2024

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

An observational study in Chronic Lower Back Pain, sponsored by Texas Back Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2024-06-25.

Sponsored by Texas Back Institute · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 49 Years
Sex
All
01

Study 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®

02

Conditions studied

  • Chronic Lower Back Pain

Keywords

  • Chronic Lower Back Pain
  • Physical Therapy
  • Discharge
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's planned enrollment of 50 is below the median of 100 across 357 observational studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Texas Back Institute is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Eligibility criteria

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

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.

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

07

Study locations

1 of 1 sites recruiting
  • Texas Back Institute
    Plano, Texas 75093, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06474429
Lead sponsor
Texas Back Institute
Responsible party
Sponsor
First posted
Jun 25, 2024
Start date
Apr 26, 2024
Primary completion
Mar 8, 2026 (estimated)
Completion
Sep 8, 2026 (estimated)
Last update
Jun 25, 2024

Study contacts

Sara R McMahan, PhD
Contact
sara.mcmahan@texasback.com
972-943-2720
Steven Kight, PT
principal investigator · Texas Back Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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