Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04716101
Status:
COMPLETED
Last Update Posted:
2022-12-06
First Post:
2021-01-14
Brief Title:
Ultrasound Imaging Measurements of the Thoracolumbar Fascia
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
Ultrasound Imaging Measurements of the Thoracolumbar Fascia Following Massage Therapy a Proof of Concept Study
Status:
COMPLETED
Status Verified Date:
2022-12
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:
In this prospective study eligible subjects with chronic non specific low back pain and asymptomatic volunteers will undergo a research dynamic ultrasound exam of the lower back before and after a massage technique
The overall aim of the present research is to develop ultrasonographic parameters that characterize the geometrical the mechanical and tissue characteristic properties of the thoracolumbar fascia and to explore the effect of a massage therapy technique on these parameters
The overall aim of the present research is to develop ultrasonographic parameters that characterize the geometrical the mechanical and tissue characteristic properties of the thoracolumbar fascia and to explore the effect of a massage therapy technique on these parameters
Detailed Description:
In this prospective proof of concept study eligible subjects with chronic non specific low back pain and asymptomatic volunteers will undergo a research dynamic ultrasound US exam of the thoracolumbar fascia TLF of the lower back A musculoskeletal radiologist will perform the US exams consisting of a series of 5 dynamic scans of both the right and left paraspinal muscles obtained during 15 degrees of passive flexion of the lower body using a motorized table
Following the US exam the group of patients and the group of volunteers will be respectively randomized to receive either a standardized massage technique intervention or a sham technique The US exam will be repeated after the intervention
Ultrasound image segmentation will be performed by two independent observers and inter-rater variability will be assessed Post-processing of the US recordings will include assessment of geometrical thickness mechanical percent shear strain between the TLF and the epimysium-muscle complex and tissue ultrastructure features the mean intensity μ the scatterer clustering parameter α and the structure parameter κ of the echo envelope These features will be compared between patients and volunteers and between the intervention groups
Following the US exam the group of patients and the group of volunteers will be respectively randomized to receive either a standardized massage technique intervention or a sham technique The US exam will be repeated after the intervention
Ultrasound image segmentation will be performed by two independent observers and inter-rater variability will be assessed Post-processing of the US recordings will include assessment of geometrical thickness mechanical percent shear strain between the TLF and the epimysium-muscle complex and tissue ultrastructure features the mean intensity μ the scatterer clustering parameter α and the structure parameter κ of the echo envelope These features will be compared between patients and volunteers and between the intervention groups
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