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| Name | Class |
|---|---|
| Parker University | OTHER |
| Miami University | OTHER |
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This research study will evaluate human performance and postural balance changes during the course of care with flexion distraction manipulation in multiple chiropractic practices.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persons receiving chiropractic care | Cox flexion distraction spinal manipulation/mobilization and other ancillary therapies as deemed fit by the treating clinician |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-Patients unable to stand normally with more than a 7 / 10 on the QVAS.
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Patients with spinal pain presenting to participating Chiropractic clinics
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| Name | Affiliation | Role |
|---|---|---|
| Maruti R Gudavalli, PhD | Keiser University-West Palm Beach Campus | Principal Investigator |
| Ralph Kruse, DC | Keiser University-West Palm Beach | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keiser University Spine care clinic | West Palm Beach | Florida | 33411 | United States |
Will be shared as long as the receiving party signs confidentiality agreement
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |