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NCT03597191 · ClinicalTrials.gov registry record · NA
Effects of Spinal Stabilization Exercises on Dynamic Balance and Functional Performance in Adults With Low Back Pain
A NA study of Low Back Pain and Chronic Low Back Pain, sponsored by Texas Woman's University.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03597191: Completed NA study of Low Back Pain and Chronic Low Back Pain, sponsored by Texas Woman's University.
NCT03597191 is a NA study of Low Back Pain and Chronic Low Back Pain that has completed, run by Texas Woman's University. The registered enrollment target is 40 participants, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03597191, a NA study of Low Back Pain and Chronic Low Back Pain, has completed, sponsored by Texas Woman's University.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators would like to know which one of two exercise programs will have a greater effect on balance, functional performance, daily function, and pain on individuals with low back pain (LBP) after 2, 4 and 8 weeks. Specifically, the differences in dynamic balance, functional performance, pain intensity, and disability level will be compared between participants who receive spinal stabilization exercises program (SSE) and those who receive a general exercise program (GE) which includes range-of-motion (ROM) and flexibility exercises. The research hypotheses are: 1. The SSE program will significantly improve dynamic balance and functional performance in adult participants with sub-acute and chronic LBP at two and four weeks as well as after an eight-week follow-up after initiating intervention. 2. The SSE program will significantly improve pain intensity and disability level in adult participants with sub-acute and chronic LBP at two and four weeks as well as after an eight-week follow-up after initiating intervention. 3. In adult participants with sub-acute and chronic LBP, the group receiving the SSE program will demonstrate significantly improved dynamic balance, functional performance, pain intensity and disability levels compared to the placebo group receiving the GE program at two and four weeks as well as after an eight-week follow-up after initiating intervention.
Primary Outcome
Dynamic balance measured by the Y-balance Test (YBT). Dynamic balance is quantified by measuring how far the reach indicator is placed relative to the stance platform while maintaining a unilateral stance. A farther reach distance is indicative of greater dynamic balance. To score each of the three directions, the reach distances (measured in cm) are averaged and normalized to the participant's leg length. As such, YBT scores are expressed as a percentage of leg length. Normalization is performe
Conditions Studied
Interventions
- OTHER Exercises
Study Locations (1)
Texas
- Texas Woman's UniversityT. Boone Pickens Institute of Health Sciences-Dallas Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-06-25 |
| Est. Completion | 2018-11-11 |
| Phase | NA |
What the finished NCT03597191 record still lists
NCT03597191 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (92% lower).
The record links to 3 conditions, with Low Back Pain appearing as the primary indexed condition, and to 1 intervention - of which Exercises is the first listed.
NCT03597191 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03597191 about?
NCT03597191 is a clinical study titled "Effects of Spinal Stabilization Exercises on Dynamic Balance and Functional Performance in Adults With Low Back Pain". The investigators would like to know which one of two exercise programs will have a greater effect on balance, functional performance, daily function, and pain on individuals with low back pain (LBP) after 2, 4 and 8 weeks. Specifically, the differences in dynamic balance, functional performance, p...
What is the current status of trial NCT03597191?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2018-06-25. Estimated completion is 2018-11-11.
What conditions does trial NCT03597191 study?
This clinical trial studies the following conditions: Low Back Pain, Chronic Low Back Pain, Subacute Low Back Pain.
What interventions are being tested in trial NCT03597191?
The interventions under investigation include: Exercises (OTHER).
Who is sponsoring clinical trial NCT03597191?
This trial is sponsored by Texas Woman's University, which has 51 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03597191 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03597191's enrollment target sits among peer trials
40 97th of 122 higher than 22 of 122 other Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Low Back Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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