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Clinical Trials/NCT04716101
NCT04716101
Completed
Not Applicable

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

Centre hospitalier de l'Université de Montréal (CHUM)1 site in 1 country64 target enrollmentFebruary 26, 2021
ConditionsLow Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Enrollment
64
Locations
1
Primary Endpoint
Change from Baseline Shear Strain After the Massage Intervention
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 26, 2021
End Date
October 31, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Change from Baseline Quantitative Ultrasound Marker 'α' After the Massage Intervention.(Baseline and immediately after the massage intervention.)
  • 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 'κ' After the Massage Intervention.(Baseline and immediately after the massage intervention.)

Study Sites (1)

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