Clinical trial NCT06965920: Influence of Flexion Distraction Manipulation on Measures of Performance and Postural Control
Official title: Influence of Flexion Distraction Manipulation on Measures of Performance and Postural Control
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Spine Condition
Low Back Pain
Keywords: spine
low back pain
spinal manipulation
spinal mobilization
spinal stenosis
Lead sponsor: Keiser University College of Chiropractic Medicine
Sponsor class: OTHER
Collaborators: name: Parker University
name: Miami University
First posted: 2025-05-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with spinal pain presenting to participating Chiropractic clinics

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Modified Test of Sensory Integration and Balance (MCTSIB) score
timeFrame: From enrollment to end of 4 weeks and 8 weeks of treatment
Secondary outcomes:
measure: Numerical pain rating scale (0-10) on neck pain, mid-back pain, and low back pain
timeFrame: From enrollment to end of 4 weeks and 8 weeks of treatment
measure: Limits of balance while standing on a force plate
timeFrame: From enrollment to end of 4 weeks and 8 weeks of treatment
measure: path length of center of pressure while standing on a single leg stance
timeFrame: From enrollment to end of 4 weeks and 8 weeks of treatment
measure: Timed up and Go test in seconds
timeFrame: From enrollment to end of 4 weeks and 8 weeks of treatment
measure: time to Sit-to-stand test for 5 repetetions
timeFrame: From enrollment to end of 4 weeks and 8 weeks of treatment
measure: • Keele STaRT Back
timeFrame: From enrollment to end of 4 weeks and 8 weeks of treatment
measure: • Assessment of Balance Confidence Questionnaire (ABC-6)
timeFrame: From enrollment to end of 4 weeks and 8 weeks of treatment
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Keiser University Spine care clinic
state: Florida
Study officials:
affiliation: Keiser University-West Palm Beach Campus
name: Maruti R Gudavalli, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Keiser University-West Palm Beach
name: Ralph Kruse, DC
role: STUDY_DIRECTOR
References: