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Completed

NCT Number: NCT07582705

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

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Key information

Conditions

Low Back Pain 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 Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Postural Low Back Pain Recurrent Low Back Pain Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal mobilization

Procedure

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

Primary outcomes

  1. Joint displacement as measured by the laboratory methods and from the lumbar mobilization feedback system.

    Time frame: 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.

  2. Applied forces as measured by the laboratory methods and lumbar mobilization feedback system

    Time frame: Change 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

  3. Tissue resistance as measured by laboratory methods and the lumbar mobilization feedback system

    Time frame: Change 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

  4. Change in muscle activation as measured by electromyography

    Time frame: Change from Baseline (day1) to immediately post-treatment (day 1)

    Differences in recorded electromyography (EMG) activity before and after administration of the intervention

  5. Change in pain threshold as measured by quantitative sensory testing.

    Time frame: 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.

  6. Brain functional connectivity as measured by functional near infrared spectroscopy

    Time frame: Change 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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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