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Completed

NCT Number: NCT04716101

Ultrasound Imaging Measurements of the Thoracolumbar Fascia

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Massage therapy technique

Other

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

Other

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 outcomes

  1. Change from Baseline Shear Strain After the Massage Intervention

    Time frame: Baseline and immediately after the massage intervention.

    Percent shear strain between the thoracolumbar fascia and the epimysium of the erector spinae muscle.

Secondary outcomes

  1. Thickness

    Time frame: Baseline

    Thickness (millimeters) of the thoracolumbar fascia.

  2. Change from Baseline Quantitative Ultrasound Marker 'μ' After the Massage Intervention.

    Time frame: Baseline and immediately after the massage intervention.

    Statistical analysis of the echo envelope: the mean intensity μ. This marker is unitless.

  3. Change from Baseline Quantitative Ultrasound Marker 'α' After the Massage Intervention.

    Time frame: Baseline and immediately after the massage intervention.

    Statistical analysis of the echo envelope: the scatterer clustering parameter α. This marker is unitless.

  4. Change from Baseline Quantitative Ultrasound Marker 'κ' After the Massage Intervention.

    Time frame: Baseline and immediately after the massage intervention.

    Statistical analysis of the echo envelope: the structure parameter κ. This marker is unitless.

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2021
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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