Influence of Flexion Distraction Manipulation on Measures of Performance and Postural Control
NCT ID: NCT06965920
Last Updated: 2025-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
100 participants
OBSERVATIONAL
2025-05-15
2026-05-14
Brief Summary
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Detailed Description
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Methods:
All patients who can stand without severe pain (able to stand normally at a 7 or below on qualitative analog visual pain scale \[QVAS\]) will be invited to participate. The goal is to recruit 150 participants from approximately 10 chiropractic practices. Volunteers will be given an informed consent document to read and if eligible and willing to participate will sign the informed consent document. At baseline and each subsequent testing visit, participants will complete the following:
* a numerical pain rating index (0-10) for each of the following: headache, neck pain, mid back pain and low back pain
* Keele STarT Back Screening Tool
* Assessment of Balance Confidence Questionnaire (ABC-6)
* Posture testing via force plate: Modified Test of Sensory Integration and Balance (MCTSIB), Single leg stance, limits of stability,
* Timed up and go and 5 times sit to stand tests The design of this study is observational, pre-post. Posture and performance testing is expected to last no more than 10 minutes per participant per visit. Subjective data will be captured via RedCap while objective data will be recorded by each clinician and uploaded to secure server.
The design of this study is observational, pre-post. Posture and performance testing is expected to last no more than 10 minutes per participant per visit. Subjective data will be captured via RedCap while objective data will be recorded by each clinician and uploaded to secure server.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Persons receiving chiropractic care
Cox flexion distraction spinal manipulation/mobilization and other ancillary therapies as deemed fit by the treating clinician
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients will be between 18-100 years of age.
* All patients with spinal pain who - can safely stand and perform the basic parameters of the test at a 7 or below on qualitative visual analog scale (QVAS) on pain will be invited to participate.
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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Parker University
OTHER
Miami University
OTHER
Keiser University College of Chiropractic Medicine
OTHER
Responsible Party
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Maruti Gudavalli
Professor
Principal Investigators
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Maruti R Gudavalli, PhD
Role: PRINCIPAL_INVESTIGATOR
Keiser University-West Palm Beach Campus
Ralph Kruse, DC
Role: STUDY_DIRECTOR
Keiser University-West Palm Beach
Locations
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Keiser University Spine care clinic
West Palm Beach, Florida, United States
Countries
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Other Identifiers
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IRB000NV23MG145
Identifier Type: -
Identifier Source: org_study_id
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