Measuring Reliability of Spine Mobilization in Low Back Pain

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

Study Overview

• Status: Completed
• Conditions: Lower Back Pain; Low Back Pain; Low Back Pain, Mechanical; Low Back Pain, Recurrent; Low Back Pain, Postural; Postural Low Back Pain; Mechanical Low Back Pain; Low Back Ache; Recurrent Low Back Pain; Lower Back Pain Chronic; Low Back Pain, Posterior Compartment; Low Backache
• Intervention / Treatment: Procedure: Spinal mobilization

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

A convenience sample of healthy subjects (faculty and students, n=25) and subjects with chronic low back pain (n=25) will be recruited from the KUMC campus. Subjects will be excluded if they report lumbar bony or joint pathology (i.e. osteoporosis, rheumatoid arthritis), lumbar/sacral deformities (i.e. spondylolisthesis, spina bifida), spinal surgery, have BMI >30, or are pregnant.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Participants; Spinal mobilization	Procedure: Spinal mobilization; The application of manual pressure to stiff spinal segments to improve mobility and control pain.
Chronic Low Back Pain Participants; Spinal mobilization	Procedure: Spinal mobilization; The application of manual pressure to stiff spinal segments to improve mobility and control pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Joint displacement as measured by the laboratory methods and from the lumbar mobilization feedback system.	The amount of joint motion for a given grade as measured by the laboratory methods and from the lumbar mobilization feedback system.	Change from Baseline (day1) to immediately post-treatment (day 1)
Applied forces as measured by the laboratory methods and lumbar mobilization feedback system	The magnitude of force produced by the clinician for each grade as measured by the laboratory methods and lumbar mobilization feedback system	Change from Baseline (day1) to immediately post-treatment (day 1)
Tissue resistance as measured by laboratory methods and the lumbar mobilization feedback system	The degree of stiffness of the joint measured as measured by laboratory methods and the lumbar mobilization feedback system	Change from Baseline (day1) to immediately post-treatment (day 1)
Change in muscle activation as measured by electromyography	Differences in recorded electromyography (EMG) activity before and after administration of the intervention	Change from Baseline (day1) to immediately post-treatment (day 1)
Change in pain threshold as measured by quantitative sensory testing.	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.	Change from Baseline (day1) to immediately post-treatment (day 1)
Brain functional connectivity as measured by functional near infrared spectroscopy	Functional near infrared spectroscopy (fNIRS) is a portable, non-invasive, and inexpensive brain imaging method of monitoring cerebral hemodynamic activity.	Change from Baseline (day1) to immediately post-treatment (day 1)

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Actual): February 2, 2025
• Study Completion (Actual): February 2, 2025

Study Registration Dates

• First Submitted: May 12, 2025
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain
• Other Study ID Numbers: STUDY00148661

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No