Measuring Reliability of Spine Mobilization in Low Back Pain

NCT07582705 | Completed

• 1 other identifier: STUDY00148661
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

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; Mechanical Low Back Pain; Recurrent Low Back Pain; Lower Back Pain Chronic; Postural Low Back Pain

Outcome Measures

Primary Outcomes (6)

• 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)

Study Arms (2)

Healthy Participants

Spinal mobilization

Procedure: Spinal mobilization

Chronic Low Back Pain Participants

Spinal mobilization

Procedure: Spinal mobilization

Interventions

Spinal mobilization PROCEDURE

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

Chronic Low Back Pain Participants; Healthy Participants

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Healthy individuals without current or recent history (within 6 months) of low back pain
• 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

You may not qualify if:

• 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
• Low signal to noise ratio fNIRS signal during calibration/setup

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 13, 2026
• Study Start: October 2, 2024
• Primary Completion: February 2, 2025
• Study Completion: February 2, 2025
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)