Ultrasound Imaging Measurements of the Thoracolumbar Fascia

Low Back Pain Clinical Trial

Official title:

Ultrasound Imaging Measurements of the Thoracolumbar Fascia Following Massage Therapy: a Proof of Concept Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04716101
• Other study ID #: CE 19.358
• Status: Completed
• Phase: N/A
• Start date: February 26, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: December 2022
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 31, 2022
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Low Back Pain

Intervention

Other:
• Massage therapy technique
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.
• Sham massage technique
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.

Locations

Country	Name	City	State
Canada	Centre hospitalier de l'Université de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Shear Strain After the Massage Intervention	Percent shear strain between the thoracolumbar fascia and the epimysium of the erector spinae muscle.	Baseline and immediately after the massage intervention.
Secondary	Thickness	Thickness (millimeters) of the thoracolumbar fascia.	Baseline
Secondary	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.	Baseline and immediately after the massage intervention.
Secondary	Change from Baseline Quantitative Ultrasound Marker 'a' After the Massage Intervention.	Statistical analysis of the echo envelope: the scatterer clustering parameter a. This marker is unitless.	Baseline and immediately after the massage intervention.
Secondary	Change from Baseline Quantitative Ultrasound Marker '?' After the Massage Intervention.	Statistical analysis of the echo envelope: the structure parameter ?. This marker is unitless.	Baseline and immediately after the massage intervention.