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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumbar Manipulation Group | Experimental | Group that receives experimental lumbar non-thrust manipulation |
|
| Sham Manipulation Group | Sham Comparator | Group that receives sham lumbar non-thrust manipulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Cleland, PhD | Nova Southeastern University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alvernia University | Reading | Pennsylvania | 19606 | United States |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Sham Manipulation | Other | Lumbar non-thrust manipulation without force applied |
|
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |