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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06965920
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Keiser University College of Chiropractic Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Maruti R Gudavalli, PhDRalph Kruse, DC
Principal Investigator Affiliation	Keiser University-West Palm Beach CampusKeiser University-West Palm Beach
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Spine Condition, Low Back Pain

Additional Details

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.

Arms & Interventions

Arms

: Persons receiving chiropractic care

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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Keiser University Spine care clinic, West Palm Beach, Florida

Status

Address

Keiser University Spine care clinic

West Palm Beach, Florida, 33411

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