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NCT06474429 · Texas Back Institute

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

What this study is about

Overview of Research Design and Objectives This study is a forward-looking, concurrent group of participants 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.

View original scientific description

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion 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

Where

  • Plano, Texas

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jun 25, 2024 · Source of record for eligibility and locations

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1 of 50 participants interested
2% interest

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Study locations

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RECRUITING

Plano

Texas

Location available
View Plano location page

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Chronic Lower Back Pain Treatment in Plano?

Join others in Texas exploring innovative treatment options through clinical research

Chronic Lower Back Pain Treatment Options in Plano, Texas

If you're searching for Chronic Lower Back Pain treatment in Plano, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Plano and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Chronic Lower Back Pain. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Texas
Now Enrolling
Up to 50 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Chronic Lower Back Pain?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Chronic Lower Back Pain

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Chronic Lower Back Pain Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06474429. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.