Ultrasound Imaging Measurements of the Thoracolumbar Fascia

NCT04716101 | Completed

• 1 other identifier: CE 19.358
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Fascia; Quantitative ultrasound; Elastography; Massage therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Thickness

  Baseline

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

  Baseline and immediately after the massage intervention.

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

  Baseline and immediately after the massage intervention.

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

  Baseline and immediately after the massage intervention.

Study Arms (2)

Patients with nonspecific low back pain

EXPERIMENTAL

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

Other: Massage therapy technique; Other: Sham massage technique

Asymptomatic volunteers

ACTIVE COMPARATOR

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

Other: Massage therapy technique; Other: Sham massage technique

Interventions

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.

Asymptomatic volunteers; Patients with nonspecific low back pain

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.

Asymptomatic volunteers; Patients with nonspecific low back pain

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

Location

Related Publications (2)

• Tomita N, Roy-Cardinal MH, Chayer B, Daher S, Attiya A, Boulanger A, Gaudreault N, Cloutier G, Bureau NJ. Thoracolumbar fascia ultrasound shear strain differs between low back pain and asymptomatic individuals: expanding the evidence. Insights Imaging. 2025 Jan 15;16(1):18. doi: 10.1186/s13244-024-01895-2.

  PMID: 39812963 RESULT

• Tomita N, Destrempes F, Cardinal MR, Boulanger A, Gaudreault N, Cloutier G, Bureau NJ. Thoracolumbar Fascia Microstructure and Low Back Pain: Insights From Quantitative Ultrasound Homodyned K-Distribution Statistical Modeling. Ultrasound Med Biol. 2025 Nov;51(11):2113-2119. doi: 10.1016/j.ultrasmedbio.2025.07.031. Epub 2025 Aug 23.

  PMID: 40850900 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nathalie J Bureau, MD MSc

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 20, 2021
• Study Start: February 26, 2021
• Primary Completion: June 22, 2022
• Study Completion: October 31, 2022
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)