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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Low Back Pain; Spine Condition

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • Florida
    • West Palm Beach, Florida, United States, 33411
      • Keiser University Spine care clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with spinal pain presenting to participating Chiropractic clinics

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Persons receiving chiropractic care; Cox flexion distraction spinal manipulation/mobilization and other ancillary therapies as deemed fit by the treating clinician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical pain rating scale (0-10) on neck pain, mid-back pain, and low back pain	Patients will enter the number corresponding to the level of pain in the three regions of the spine into a RedCap system. • Minimum value 0; Maximum value 10; higher values are worse pain scores	From enrollment to end of 4 weeks and 8 weeks of treatment
Limits of balance while standing on a force plate	Patients will be asked to stand on a force plate and asked to lean forward, backward, and side ways (right and left). The limits of the center of pressure in anterior to posterior and lateral direction will be obtained using balance software. Center of pressure (COP) area is tested in four directions; front left (FL), back left (BL), back right (BR), and front right (FR) with an overall area provided; higher values represent better limits of stability	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	Patient will be asked to stand on a single leg for a maximum of 20 seconds. • Center of Pressure (COP) Path Lengths (PLs) for each leg and Asymmetry Index (ASI); higher COP values represent worse postural stability	From enrollment to end of 4 weeks and 8 weeks of treatment
Timed up and Go test in seconds	Patients will be asked to get up from a chair and walk and time will be recorded. • Time in seconds to complete; greater time in seconds represents worse mobility and balance	From enrollment to end of 4 weeks and 8 weeks of treatment
time to Sit-to-stand test for 5 repetetions	Patients will be asked to stand from a sitting position on a chair and repeated for 5 times. Time taken will be recorded. Time in seconds to complete; greater time in seconds represents worse lower extremity performance	From enrollment to end of 4 weeks and 8 weeks of treatment
• Keele STaRT Back	The STarT Back Screening Tool helps primary care clinicians (GPs, physiotherapists etc) to group patients into three categories of risk of poor outcome (persistent disabling symptoms) - low, medium, and high-risk. By being able to categorise patients into these 3 groups, clinicians are then able to target interventions to each sub-group of patients to help outcome. Minimum value 0; Maximum value 9; higher values represent higher risk of poor outcome	From enrollment to end of 4 weeks and 8 weeks of treatment
• Assessment of Balance Confidence Questionnaire (ABC-6)	This is a functional short form balance confidence questionnaire consisting of 6 questions with a scale of 0-100 for each question. Percent balance confidence - Minimum value 0%; Maximum value 100%; higher values represent greater balance confidence	From enrollment to end of 4 weeks and 8 weeks of treatment

Collaborators and Investigators

• Sponsor: Keiser University College of Chiropractic Medicine
• Collaborators: Parker University; Miami University
• Investigators: Principal Investigator: Maruti R Gudavalli, PhD, Keiser University-West Palm Beach Campus; Study Director: Ralph Kruse, DC, Keiser University-West Palm Beach

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2025
• Primary Completion (Estimated): May 14, 2026
• Study Completion (Estimated): May 14, 2026

Study Registration Dates

• First Submitted: May 2, 2025
• First Submitted That Met QC Criteria: May 2, 2025
• First Posted (Actual): May 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: spinal manipulation; low back pain; spine; spinal stenosis; spinal mobilization
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IRB000NV23MG145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Will be shared as long as the receiving party signs confidentiality agreement

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No