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Ultrasound Imaging Measurements of the Thoracolumbar Fascia

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Massage therapy technique
Sham massage technique
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Low Back Pain focused on measuring Fascia, Quantitative ultrasound, Elastography, Massage therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patient group:

  • Presenting with chronic low back and/or referred pain (non specific pattern) above or just below the gluteal fold of at least 3/10 on a numerical pain rating scale (NRS), for at least 6 months;
  • Pain is present at least 50% of the time during the day;

Asymptomatic group:

  • No history of low back pain or any other chronic pain limiting activities of daily living or work.

Exclusion Criteria:

  • History of back surgery;
  • History of severe back or low extremity injury;
  • Back pain attributable to a specific, recognizable, known pathology (i.e.: infection, tumor, fracture, spinal stenosis, sciatica etc.);
  • Corticosteroid medication intake or corticosteroid injection in the lumbar spine in the previous 3 months;
  • Pregnancy.

Sites / Locations

  • Centre hospitalier de l'Université de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients with nonspecific low back pain

Asymptomatic volunteers

Arm Description

Patients will be randomized to receive either a massage technique or a sham massage technique.

Similarly, the volunteers will be randomized to receive either a massage technique or a sham massage technique.

Outcomes

Primary Outcome Measures

Change from Baseline Shear Strain After the Massage Intervention
Percent shear strain between the thoracolumbar fascia and the epimysium of the erector spinae muscle.

Secondary Outcome Measures

Thickness
Thickness (millimeters) of the thoracolumbar fascia.
Change from Baseline Quantitative Ultrasound Marker 'μ' After the Massage Intervention.
Statistical analysis of the echo envelope: the mean intensity μ. This marker is unitless.
Change from Baseline Quantitative Ultrasound Marker 'α' After the Massage Intervention.
Statistical analysis of the echo envelope: the scatterer clustering parameter α. This marker is unitless.
Change from Baseline Quantitative Ultrasound Marker 'κ' After the Massage Intervention.
Statistical analysis of the echo envelope: the structure parameter κ. This marker is unitless.

Full Information

First Posted
January 14, 2021
Last Updated
December 2, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT04716101
Brief Title
Ultrasound Imaging Measurements of the Thoracolumbar Fascia
Official Title
Ultrasound Imaging Measurements of the Thoracolumbar Fascia Following Massage Therapy: a Proof of Concept Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
June 22, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Fascia, Quantitative ultrasound, Elastography, Massage therapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with nonspecific low back pain
Arm Type
Experimental
Arm Description
Patients will be randomized to receive either a massage technique or a sham massage technique.
Arm Title
Asymptomatic volunteers
Arm Type
Active Comparator
Arm Description
Similarly, the volunteers will be randomized to receive either a massage technique or a sham massage technique.
Intervention Type
Other
Intervention Name(s)
Massage therapy technique
Intervention Description
The massage therapy technique consists of manual deep and slow compression and shearing forces applied on the lumbar spine muscles and thoracolumbar fascia in a distal to proximal direction.
Intervention Type
Other
Intervention Name(s)
Sham massage technique
Intervention Description
For the sham massage technique the massage therapist will put the right palm at the participant's right lower back along erector spinae and likewise left palm at left lower back without applying force, holding the palm during 2 minutes and half.
Primary Outcome Measure Information:
Title
Change from Baseline Shear Strain After the Massage Intervention
Description
Percent shear strain between the thoracolumbar fascia and the epimysium of the erector spinae muscle.
Time Frame
Baseline and immediately after the massage intervention.
Secondary Outcome Measure Information:
Title
Thickness
Description
Thickness (millimeters) of the thoracolumbar fascia.
Time Frame
Baseline
Title
Change from Baseline Quantitative Ultrasound Marker 'μ' After the Massage Intervention.
Description
Statistical analysis of the echo envelope: the mean intensity μ. This marker is unitless.
Time Frame
Baseline and immediately after the massage intervention.
Title
Change from Baseline Quantitative Ultrasound Marker 'α' After the Massage Intervention.
Description
Statistical analysis of the echo envelope: the scatterer clustering parameter α. This marker is unitless.
Time Frame
Baseline and immediately after the massage intervention.
Title
Change from Baseline Quantitative Ultrasound Marker 'κ' After the Massage Intervention.
Description
Statistical analysis of the echo envelope: the structure parameter κ. This marker is unitless.
Time Frame
Baseline and immediately after the massage intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient group: Presenting with chronic low back and/or referred pain (non specific pattern) above or just below the gluteal fold of at least 3/10 on a numerical pain rating scale (NRS), for at least 6 months; Pain is present at least 50% of the time during the day; Asymptomatic group: No history of low back pain or any other chronic pain limiting activities of daily living or work. Exclusion Criteria: History of back surgery; History of severe back or low extremity injury; Back pain attributable to a specific, recognizable, known pathology (i.e.: infection, tumor, fracture, spinal stenosis, sciatica etc.); Corticosteroid medication intake or corticosteroid injection in the lumbar spine in the previous 3 months; Pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie J Bureau, MD MSc
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier de l'Université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0C1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Ultrasound Imaging Measurements of the Thoracolumbar Fascia

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