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Ultrasound Imaging Measurements of the Thoracolumbar Fascia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04716101
Enrollment
64
Registered
2021-01-20
Start date
2021-02-26
Completion date
2022-10-31
Last updated
2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Fascia, Quantitative ultrasound, Elastography, Massage therapy

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.

Interventions

OTHERMassage 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.

OTHERSham 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.

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Shear Strain After the Massage InterventionBaseline and immediately after the massage intervention.Percent shear strain between the thoracolumbar fascia and the epimysium of the erector spinae muscle.

Secondary

MeasureTime frameDescription
ThicknessBaselineThickness (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 '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.
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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026