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Measuring Reliability of Spine Mobilization in Low Back Pain

Measuring Reliability of Spine Mobilization in Low Back Pain

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07582705
Enrollment
50
Registered
2026-05-13
Start date
2024-10-02
Completion date
2025-02-02
Last updated
2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Low Back Ache, Low Back Pain, Mechanical, Low Back Pain, Posterior Compartment, Low Back Pain, Postural, Low Back Pain, Recurrent, Low Backache, Lower Back Pain, Lower Back Pain Chronic, Mechanical Low Back Pain, Postural Low Back Pain, Recurrent Low Back Pain

Brief summary

This observational study aims to learn how to measure joint motion and tissue response when pressure is applied to the back and examine how the nervous system responds to the applied pressure. This pressure or mobilization technique is a standard care but we currently do not have a method to measure this technique. Through this study, we hope to validate a tool that allows physical therapists to measure the pressure applied during spinal mobilization. Participants will be asked to: * Receive spinal mobilization * Participate in pain threshold testing * Answer questionnaires

Interventions

The application of manual pressure to stiff spinal segments to improve mobility and control pain.

Sponsors

University of Kansas Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy individuals without current or recent history (within 6 months) of low back pain * 18-70 years of age * BMI between 18.5-29.9 * Ability to read and understand English * For those with chronic low back pain: 1) low back pain more than 3 months and 2) a minimal pain level of 3 on the 0-10 pain numerical rating scale (NRS) in the last 7 days

Exclusion criteria

* Any signs or symptoms of lumbar pathology (as reported by the participant during interview such as low back pain, or lower limb neurological signs) * History of any spinal surgery * Lumbar/sacral conditions reported by the subject such as spondylolithesis, spina bifida or spinal fracture * Bony pathology such as osteoporosis or rheumatoid arthritis as reported by the participant * Pregnancy * Spine cancer * BMI \>30 * Unable to lay on stomach * Resting blood pressure more than 160/90 mmHg * Currently taking blood thinning medications * Uncontrolled diabetes * A medical exclusion from having blood pressure taken such as a peripheral neuropathy * Low signal to noise ratio fNIRS signal during calibration/setup

Design outcomes

Primary

MeasureTime frameDescription
Joint displacement as measured by the laboratory methods and from the lumbar mobilization feedback system.Change from Baseline (day1) to immediately post-treatment (day 1)The amount of joint motion for a given grade as measured by the laboratory methods and from the lumbar mobilization feedback system.
Applied forces as measured by the laboratory methods and lumbar mobilization feedback systemChange from Baseline (day1) to immediately post-treatment (day 1)The magnitude of force produced by the clinician for each grade as measured by the laboratory methods and lumbar mobilization feedback system
Tissue resistance as measured by laboratory methods and the lumbar mobilization feedback systemChange from Baseline (day1) to immediately post-treatment (day 1)The degree of stiffness of the joint measured as measured by laboratory methods and the lumbar mobilization feedback system
Change in muscle activation as measured by electromyographyChange from Baseline (day1) to immediately post-treatment (day 1)Differences in recorded electromyography (EMG) activity before and after administration of the intervention
Change in pain threshold as measured by quantitative sensory testing.Change from Baseline (day1) to immediately post-treatment (day 1)The following tests will be used to test sensation threshold before and after grade I - IV mobilization/clinician: pressure pain threshold, conditioned pain modulation, and temporal summation.
Brain functional connectivity as measured by functional near infrared spectroscopyChange from Baseline (day1) to immediately post-treatment (day 1)Functional near infrared spectroscopy (fNIRS) is a portable, non-invasive, and inexpensive brain imaging method of monitoring cerebral hemodynamic activity.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026