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

Keiser University College of Chiropractic Medicine

Status: Invitation-only

Conditions: Spine Condition; Low Back Pain

Study type: Observational

Funder types: Other

Identifiers

NCT06965920

IRB000NV23MG145

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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 design

100 participants in 1 patient group

Persons receiving chiropractic care

Description:

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