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Completed

NCT Number: NCT04646018

The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Individuals With Low Back Pain

The purpose of this experiment is to determine the effects of a non-thrust manipulation procedure on muscle function, spinal mobility, and pain level on those experiencing low back pain (LBP) in a sample of individuals who identify English as their primary language. The rationale for this language criterion is provided in Section 9:F of this application. Muscle function will be measured via the muscle thickness of a deep spinal stabilizing muscle (multifidus, MF) while in both a resting state and during a maximum voluntary contraction (MVC). Spinal mobility will be measured as the active range of motion of both forward and backward trunk bending. Pain level will be a self-report measure recorded during rest and active range of motion.

Hypothesis 1: A non-thrust manipulation procedure will increase the thickness of the sacral multifidus both at rest and during a maximum voluntary contraction

Hypothesis 2: A non-thrust manipulation procedure will result in greater low back active range of motion.

Hypothesis 3: A non-thrust manipulation procedure will result in a reduction in the participant's self-reported pain levels both at rest and during active range of motion movements.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alvernia University

Reading, Pennsylvania, 19606, United States

About this study

The proposed study aims to determine if the impact of a newly-described manual procedure, that includes a non-thrust force applied to the low back region, has an impact on patient centered-outcomes. Rehabilitation Ultrasound Imaging (RUSI) will be used to determine MF muscle thickness (MT) at rest and during a maximum voluntary contraction (MVC) immediately following application of the manual procedure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants are individuals with current complaint of low back pain, defined as pain that is present in the region from just below the rib cage to just below the buttocks.
  • Participants will be 18 years of age or older
  • Participants must be experiencing an episode of low back pain at the present time that is at any level on a Numerical Pain Rating Scale & Pain Diagram (NPRS) from 1-10
  • Participants must demonstrate the ability to maintain standing and prone postures for several minutes at a time and perform lumbar active range of motion in a standing position
  • Participants must report the presence of their low back pain during performance of active forward and/or backward bending in standing
  • Participants must demonstrate the ability to communicate in conversational English, that includes speaking, reading, and writing.

Exclusion criteria

  • Participants who are currently involved in litigation that is directly related to the participant's current episode of low back pain
  • Participants with known or suspected pregnancy
  • Participants with confirmed diagnosis of any of the following conditions:
  • Central nervous system disorder
  • Rheumatoid Arthritis
  • Spinal Fracture
  • Spondyloarthropathy (i.e., Ankylosing Spondylitis)
  • Tumor or infection of the spine

Treatment and study plan

Lumbar Spine Manipulation

Other

Lumbar non-thrust manipulation is a passive movement that is performed with a rhythm and a grade in a manner in which the patient is able to prevent the technique from being performed.

Sham Manipulation

Other

Lumbar non-thrust manipulation without force applied

Primary outcomes

  1. Changes in Sacral Multifidus Muscle Thickness

    Time frame: Change from Pre to immediately Post Manipulation/Sham

    Rehabilitation Ultrasound Images of Sacral Multifidus muscle thickness at rest and during a maximal isometric contraction

Secondary outcomes

  1. Changes in Lumbar Active Range of Motion

    Time frame: Change from Pre to immediately Post Manipulation/Sham

    Inclinometry of Lumbar Active Range of Motion in Standing

  2. Changes in Low Back Pain

    Time frame: Change from Baseline to immediately Post Manipulation/Sham to 24-48 hours post session

    Visual Analogue Scale of Low Back Pain (0-10 scale with 0=least pain, 10=worst pain)

  3. Changes in Oswestry Disability Questionnaire (0-100 scale, 0=no disability, 100=bed bound, exaggerating symptoms)

    Time frame: Change from Baseline to 24-48 hours post session

    Self-assessment disability paper survey

  4. Changes in Fear-Avoidance Beliefs Questionnaire (0-96, 96=maximum fear-avoidance beliefs)

    Time frame: Change from Baseline to 24-48 hours post session

    Self-assessment disability paper survey

  5. Changes in Global Rating of Change (-7 to +7 scale, -7=a very great deal worse, +7=a very great deal better)

    Time frame: Change from Baseline to 24-48 hours post session

    Self-assessment disability paper survey

Sponsors and collaborators

Lead sponsor

Alvernia University

Other

Registry information

Official study title

The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Muscle Thickness of the Sacral Multifidi, Lumbar Motion, and Self-Reported Pain

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 27, 2020
Registry last updated
Nov 27, 2020

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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