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Enrolling by Invitation

NCT Number: NCT06965920

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.

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Key information

Conditions

Spine Condition Back Pain Bone Diseases Low Back Pain Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases Spinal Stenosis

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Keiser University Spine care clinic

West Palm Beach, Florida, 33411, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Modified Test of Sensory Integration and Balance (MCTSIB) score

    Time frame: From enrollment to end of 4 weeks and 8 weeks of treatment

    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

Secondary outcomes

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

    Time frame: From enrollment to end of 4 weeks and 8 weeks of treatment

    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

  2. Limits of balance while standing on a force plate

    Time frame: From enrollment to end of 4 weeks and 8 weeks of treatment

    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

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

    Time frame: From enrollment to end of 4 weeks and 8 weeks of treatment

    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

  4. Timed up and Go test in seconds

    Time frame: From enrollment to end of 4 weeks and 8 weeks of treatment

    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

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

    Time frame: From enrollment to end of 4 weeks and 8 weeks of treatment

    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

  6. • Keele STaRT Back

    Time frame: From enrollment to end of 4 weeks and 8 weeks of treatment

    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

  7. • Assessment of Balance Confidence Questionnaire (ABC-6)

    Time frame: From enrollment to end of 4 weeks and 8 weeks of treatment

    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

Sponsors and collaborators

Lead sponsor

Keiser University College of Chiropractic Medicine

Other

Collaborators

  • Miami University
  • Parker University

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 11, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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