Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04646018
Status:
COMPLETED
Last Update Posted:
2020-11-27
First Post:
2020-11-05
Brief Title:
The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Individuals With Low Back Pain
Sponsor:
Alvernia University
Organization:
Alvernia University
Study Overview
Official Title:
The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Muscle Thickness of the Sacral Multifidi Lumbar Motion and Self-Reported Pain
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 9F 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 participants self-reported pain levels both at rest and during active range of motion movements
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 participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None