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

NCT06965920 | Enrolling By Invitation

• 1 other identifier: IRB000NV23MG145
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Condition; Low Back Pain

Keywords

spine; low back pain; spinal manipulation; spinal mobilization; spinal stenosis

Outcome Measures

Primary Outcomes (1)

• Modified Test of Sensory Integration and Balance (MCTSIB) score

  MCTSIB is a testing protocol available with BTracks balance system. Patients are asked to stand on a force plate for 20 seconds in four different conditions a) stand on a firm surface with eyes open b) stand on a firm surface with eyes closed c) stand on a foam with eyes open and d) stand on a foam with eyes closed. The path length of the center of pressure movement is quantified with a score. • Center of Pressure (COP) Path Lengths (PLs) under conditions of eyes open (EO), eyes closed (EC), eyes open foam (EOF), and eyes closed foam (ECF); higher values represent worse postural stability

  From enrollment to end of 4 weeks and 8 weeks of treatment

Secondary Outcomes (7)

• Numerical pain rating scale (0-10) on neck pain, mid-back pain, and low back pain

  From enrollment to end of 4 weeks and 8 weeks of treatment

• Limits of balance while standing on a force plate

  From enrollment to end of 4 weeks and 8 weeks of treatment

• path length of center of pressure while standing on a single leg stance

  From enrollment to end of 4 weeks and 8 weeks of treatment

• Timed up and Go test in seconds

  From enrollment to end of 4 weeks and 8 weeks of treatment

• time to Sit-to-stand test for 5 repetetions

  From enrollment to end of 4 weeks and 8 weeks of treatment

Study Arms (1)

Persons receiving chiropractic care

Cox flexion distraction spinal manipulation/mobilization and other ancillary therapies as deemed fit by the treating clinician

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with spinal pain presenting to participating Chiropractic clinics

You may qualify if:

• 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.

You may not qualify if:

• Patients unable to stand normally with more than a 7 / 10 on the QVAS.

Sponsors & Collaborators

• Keiser University College of Chiropractic Medicine: lead
• Parker University: collaborator
• Miami University: collaborator

Study Sites (1)

Keiser University Spine care clinic

West Palm Beach, Florida, 33411, United States

Location

MeSH Terms

Conditions

Low Back Pain; Spinal Stenosis

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Maruti R Gudavalli, PhD

  Keiser University-West Palm Beach Campus

  PRINCIPAL INVESTIGATOR

• Ralph Kruse, DC

  Keiser University-West Palm Beach

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 11, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): May 14, 2026
• Study Completion (Estimated): May 14, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

US (1)