The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Individuals With Low Back Pain
- Conditions
- Low Back Pain
- Interventions
- Other: Lumbar Spine ManipulationOther: Sham Manipulation
- Registration Number
- NCT04646018
- Lead Sponsor
- Alvernia University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- 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.
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Participants who are currently involved in litigation that is directly related to the participant's current episode of low back pain
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Participants with known or suspected pregnancy
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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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lumbar Manipulation Group Lumbar Spine Manipulation Group that receives experimental lumbar non-thrust manipulation Sham Manipulation Group Sham Manipulation Group that receives sham lumbar non-thrust manipulation
- Primary Outcome Measures
Name Time Method Changes in Sacral Multifidus Muscle Thickness 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 Outcome Measures
Name Time Method 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 Self-assessment disability paper survey
Changes in Fear-Avoidance Beliefs Questionnaire (0-96, 96=maximum fear-avoidance beliefs) Change from Baseline to 24-48 hours post session Self-assessment disability paper survey
Changes in Lumbar Active Range of Motion Change from Pre to immediately Post Manipulation/Sham Inclinometry of Lumbar Active Range of Motion in Standing
Changes in Low Back Pain 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)
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 Self-assessment disability paper survey
Trial Locations
- Locations (1)
Alvernia University
🇺🇸Reading, Pennsylvania, United States