Influence of Flexion Distraction Manipulation on Measures of Performance and Postural Control

NCT ID: NCT06965920

Last Updated: 2025-05-18

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-15

Study Completion Date

2026-05-14

Brief Summary

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This research study will evaluate human performance and postural balance changes during the course of care with flexion distraction manipulation in multiple chiropractic practices.

Detailed Description

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Objective This research study will evaluate human performance and postural balance changes during the course of care with flexion distraction manipulation in multiple chiropractic practices.

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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Spine Condition Low Back Pain

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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

* New patients with spinal pain,
* 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

-Patients unable to stand normally with more than a 7 / 10 on the QVAS.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parker University

OTHER

Sponsor Role collaborator

Miami University

OTHER

Sponsor Role collaborator

Keiser University College of Chiropractic Medicine

OTHER

Sponsor Role lead

Responsible Party

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Maruti Gudavalli

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Other Identifiers

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IRB000NV23MG145

Identifier Type: -

Identifier Source: org_study_id

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