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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumbar Spine Manipulation
Sham Manipulation
Sponsored by
Alvernia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alvernia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Lumbar Manipulation Group

Sham Manipulation Group

Arm Description

Group that receives experimental lumbar non-thrust manipulation

Group that receives sham lumbar non-thrust manipulation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in Lumbar Active Range of Motion
Inclinometry of Lumbar Active Range of Motion in Standing
Changes in Low Back Pain
Visual Analogue Scale of Low Back Pain (0-10 scale with 0=least pain, 10=worst pain)
Changes in Oswestry Disability Questionnaire (0-100 scale, 0=no disability, 100=bed bound, exaggerating symptoms)
Self-assessment disability paper survey
Changes in Fear-Avoidance Beliefs Questionnaire (0-96, 96=maximum fear-avoidance beliefs)
Self-assessment disability paper survey
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

Full Information

First Posted
November 5, 2020
Last Updated
November 20, 2020
Sponsor
Alvernia University
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1. Study Identification

Unique Protocol Identification Number
NCT04646018
Brief Title
The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Individuals With Low Back Pain
Official Title
The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Muscle Thickness of the Sacral Multifidi, Lumbar Motion, and Self-Reported Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
October 7, 2020 (Actual)
Study Completion Date
October 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alvernia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumbar Manipulation Group
Arm Type
Experimental
Arm Description
Group that receives experimental lumbar non-thrust manipulation
Arm Title
Sham Manipulation Group
Arm Type
Sham Comparator
Arm Description
Group that receives sham lumbar non-thrust manipulation
Intervention Type
Other
Intervention Name(s)
Lumbar Spine Manipulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Manipulation
Intervention Description
Lumbar non-thrust manipulation without force applied
Primary Outcome Measure Information:
Title
Changes in Sacral Multifidus Muscle Thickness
Description
Rehabilitation Ultrasound Images of Sacral Multifidus muscle thickness at rest and during a maximal isometric contraction
Time Frame
Change from Pre to immediately Post Manipulation/Sham
Secondary Outcome Measure Information:
Title
Changes in Lumbar Active Range of Motion
Description
Inclinometry of Lumbar Active Range of Motion in Standing
Time Frame
Change from Pre to immediately Post Manipulation/Sham
Title
Changes in Low Back Pain
Description
Visual Analogue Scale of Low Back Pain (0-10 scale with 0=least pain, 10=worst pain)
Time Frame
Change from Baseline to immediately Post Manipulation/Sham to 24-48 hours post session
Title
Changes in Oswestry Disability Questionnaire (0-100 scale, 0=no disability, 100=bed bound, exaggerating symptoms)
Description
Self-assessment disability paper survey
Time Frame
Change from Baseline to 24-48 hours post session
Title
Changes in Fear-Avoidance Beliefs Questionnaire (0-96, 96=maximum fear-avoidance beliefs)
Description
Self-assessment disability paper survey
Time Frame
Change from Baseline to 24-48 hours post session
Title
Changes in Global Rating of Change (-7 to +7 scale, -7=a very great deal worse, +7=a very great deal better)
Description
Self-assessment disability paper survey
Time Frame
Change from Baseline to 24-48 hours post session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Cleland, PhD
Organizational Affiliation
Nova Southeastern University
Official's Role
Study Chair
Facility Information:
Facility Name
Alvernia University
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19606
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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