Chronic Lower Back PainNCT06474429
Assessing the Functional Movement Screen as a Reliable Physical Therapy Discharge Criteria for Chronic Lower Back Pain Patients
An observational study of Chronic Lower Back Pain, run by Texas Back Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Chronic Lower Back Pain
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2024to 8 Sep 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Texas Back Institute
Plano, Texas, 75093
Sara R McMahan, PhD, 972-943-2720, sara.mcmahan@texasback.com
Sara McMahan, PhD
About this study
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.
Read more
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start26 Apr 2024
- Primary completion8 Mar 2026 (estimated)
- Study completion8 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lower Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Texas Back Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Kight, PT, Principal investigator, Texas Back Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474429
- Sponsor's protocol ID
- 2169799
- Status last verified
- Mar 2024
- First submitted
- 19 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Functional Movement Screen as a Reliable Physical Therapy Discharge Criteria for Chronic Lower Back Pain Patients
- ClinicalTrials.gov ID
- NCT06474429
- Acronym / sponsor ID
- 2169799
- Conditions
- Chronic Lower Back Pain
- Keywords
- Chronic Lower Back Pain, Physical Therapy, Discharge
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Texas Back InstituteUniversity, hospital or other
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 8 Mar 2026 (estimated)
- Study completion
- 8 Sep 2026 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Kight, PT principal investigator
Texas Back Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lower Back Pain, run by Texas Back Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara R McMahan, PhD (972-943-2720, sara.mcmahan@texasback.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average FMS Scores (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.