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

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Lumbar Spine Manipulation; Other: Sham Manipulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Reading, Pennsylvania, United States, 19606
      • Alvernia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. Participants will be 18 years of age or older
3. 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
4. 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
5. Participants must report the presence of their low back pain during performance of active forward and/or backward bending in standing
6. Participants must demonstrate the ability to communicate in conversational English, that includes speaking, reading, and writing.

Exclusion Criteria:

1. Participants who are currently involved in litigation that is directly related to the participant's current episode of low back pain
2. Participants with known or suspected pregnancy

3. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lumbar Manipulation Group; Group that receives experimental lumbar non-thrust manipulation	Other: Lumbar Spine Manipulation; 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 Comparator: Sham Manipulation Group; Group that receives sham lumbar non-thrust manipulation	Other: Sham Manipulation; Lumbar non-thrust manipulation without force applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Sacral Multifidus Muscle Thickness	Rehabilitation Ultrasound Images of Sacral Multifidus muscle thickness at rest and during a maximal isometric contraction	Change from Pre to immediately Post Manipulation/Sham

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Lumbar Active Range of Motion	Inclinometry of Lumbar Active Range of Motion in Standing	Change from Pre to immediately Post Manipulation/Sham
Changes in Low Back Pain	Visual Analogue Scale of Low Back Pain (0-10 scale with 0=least pain, 10=worst pain)	Change from Baseline to immediately Post Manipulation/Sham to 24-48 hours post session
Changes in Oswestry Disability Questionnaire (0-100 scale, 0=no disability, 100=bed bound, exaggerating symptoms)	Self-assessment disability paper survey	Change from Baseline to 24-48 hours post session
Changes in Fear-Avoidance Beliefs Questionnaire (0-96, 96=maximum fear-avoidance beliefs)	Self-assessment disability paper survey	Change from Baseline to 24-48 hours post session
Changes in Global Rating of Change (-7 to +7 scale, -7=a very great deal worse, +7=a very great deal better)	Self-assessment disability paper survey	Change from Baseline to 24-48 hours post session

Collaborators and Investigators

• Sponsor: Alvernia University
• Investigators: Study Chair: Joshua Cleland, PhD, Nova Southeastern University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Actual): October 7, 2020
• Study Completion (Actual): October 7, 2020

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: AlverniaU

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