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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04646018
• Other study ID #: AlverniaU
• Status: Completed
• Phase: N/A
• Start date: May 20, 2020
• Est. completion date: October 7, 2020

Study information

• Verified date: November 2020
• Source: Alvernia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 7, 2020
• Est. primary completion date: October 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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 Manipulation
Lumbar non-thrust manipulation without force applied

Locations

Country	Name	City	State
United States	Alvernia University	Reading	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Alvernia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in Lumbar Active Range of Motion	Inclinometry of Lumbar Active Range of Motion in Standing	Change from Pre to immediately Post Manipulation/Sham
Secondary	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
Secondary	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
Secondary	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
Secondary	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