Influence of Flexion Distraction Manipulation on Measures of Performance and Postural Control
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Spine Condition, Low Back Pain. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Modified Test of Sensory Integration and Balance (MCTSIB) score [Time frame: From enrollment to end of 4 weeks and 8 weeks of treatment]
Secondary outcome measures (7)
- 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]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Keiser University Spine care clinic — West Palm Beach
Identifiers
NCT: NCT06965920 · IRB000NV23MG145