Spine ConditionNCT06965920
Influence of Flexion Distraction Manipulation on Measures of Performance and Postural Control
An observational study of Spine Condition and Low Back Pain, run by Keiser University College of Chiropractic Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Spine Condition, Low Back Pain
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2025to 14 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with spinal pain presenting to participating Chiropractic clinics
Who may be able to join
- 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.
Who cannot join
- -Patients unable to stand normally with more than a 7 / 10 on the QVAS.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Keiser University Spine care clinic
West Palm Beach, Florida, 33411
About this study
This research study will evaluate human performance and postural balance changes during the course of care with flexion distraction manipulation in multiple chiropractic practices.
Read the 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.
- Conditions
- Spine Condition, Low Back Pain
- Keywords
- spine, low back pain, spinal manipulation, spinal mobilization, spinal stenosis
- Medical subject headings
- Low Back Pain, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Persons receiving chiropractic care | Cox flexion distraction spinal manipulation/mobilization and other ancillary therapies as deemed fit by the treating clinician |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From enrollment to end of 4 weeks and 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start15 May 2025 (estimated)
- Primary completion14 May 2026 (estimated)
- Study completion14 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keiser University College of Chiropractic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Parker University, Miami University
- Responsible party
- Principal investigator, Maruti Gudavalli, Keiser University College of Chiropractic Medicine
- Investigators
- Maruti R Gudavalli, PhD, Principal investigator, Keiser University-West Palm Beach CampusRalph Kruse, DC, Study director, Keiser University-West Palm Beach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965920
- Sponsor's protocol ID
- IRB000NV23MG145
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will be shared as long as the receiving party signs confidentiality agreement
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Flexion Distraction Manipulation on Measures of Performance and Postural Control
- ClinicalTrials.gov ID
- NCT06965920
- Acronym / sponsor ID
- IRB000NV23MG145
- Conditions
- Spine Condition, Low Back Pain
- Keywords
- spine, low back pain, spinal manipulation, spinal mobilization, spinal stenosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Keiser University College of Chiropractic MedicineUniversity, hospital or other
- Collaborators
- Parker University, Miami University
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 14 May 2026 (estimated)
- Study completion
- 14 May 2026 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons receiving chiropractic care | – | –Cox flexion distraction spinal manipulation/mobilization and other ancillary therapies as deemed fit by the treating clinician |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with spinal pain presenting to participating Chiropractic clinics
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -Patients unable to stand normally with more than a 7 / 10 on the QVAS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
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
Limits of balance while standing on a force plate
Time frame: 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
Time frame: From enrollment to end of 4 weeks and 8 weeks of treatment
Timed up and Go test in seconds
Time frame: From enrollment to end of 4 weeks and 8 weeks of treatment
time to Sit-to-stand test for 5 repetetions
Time frame: From enrollment to end of 4 weeks and 8 weeks of treatment
• Keele STaRT Back
Time frame: From enrollment to end of 4 weeks and 8 weeks of treatment
• Assessment of Balance Confidence Questionnaire (ABC-6)
Time frame: From enrollment to end of 4 weeks and 8 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: Undecided. Will be shared as long as the receiving party signs confidentiality agreement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maruti R Gudavalli, PhD principal investigator
Keiser University-West Palm Beach Campus
Ralph Kruse, DC study director
Keiser University-West Palm Beach
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Condition and Low Back Pain, run by Keiser University College of Chiropractic Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Test of Sensory Integration and Balance (MCTSIB) score (time frame: From enrollment to end of 4 weeks and 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.