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

NCT04646018 | Completed

• 1 other identifier: AlverniaU
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes in Lumbar Active Range of Motion

  Change from Pre to immediately Post Manipulation/Sham

• Changes in Low Back 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)

  Change from Baseline to 24-48 hours post session

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

  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)

  Change from Baseline to 24-48 hours post session

Study Arms (2)

Lumbar Manipulation Group

EXPERIMENTAL

Group that receives experimental lumbar non-thrust manipulation

Other: Lumbar Spine Manipulation

Sham Manipulation Group

SHAM COMPARATOR

Group that receives sham lumbar non-thrust manipulation

Other: Sham Manipulation

Interventions

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.

Lumbar Manipulation Group

Sham Manipulation OTHER

Lumbar non-thrust manipulation without force applied

Sham Manipulation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alvernia University: lead

Study Sites (1)

Alvernia University

Reading, Pennsylvania, 19606, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Joshua Cleland, PhD

  Nova Southeastern University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapy Department Chair, Professor of Physical Therapy

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 27, 2020
• Study Start: May 20, 2020
• Primary Completion: October 7, 2020
• Study Completion: October 7, 2020
• Last Updated: November 27, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)