Ultrasound Imaging Measurements of the Thoracolumbar Fascia

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: Massage therapy technique; Other: Sham massage technique

• Registration Number: NCT04716101
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Study Timeline

• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-18
• Study First Posted: 2021-01-20
• Study Start: 2021-02-26
• Primary Completion: 2022-06-22
• Study Completion: 2022-10-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with nonspecific low back pain	Massage therapy technique	Patients will be randomized to receive either a massage technique or a sham massage technique.
Asymptomatic volunteers	Sham massage technique	Similarly, the volunteers will be randomized to receive either a massage technique or a sham massage technique.
Patients with nonspecific low back pain	Sham massage technique	Patients will be randomized to receive either a massage technique or a sham massage technique.
Asymptomatic volunteers	Massage therapy technique	Similarly, the volunteers will be randomized to receive either a massage technique or a sham massage technique.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Shear Strain After the Massage Intervention	Baseline and immediately after the massage intervention.	Percent shear strain between the thoracolumbar fascia and the epimysium of the erector spinae muscle.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre hospitalier de l'Université de Montréal; 🇨🇦 Montréal, Quebec, Canada