Ultrasound Imaging Measurements of the Thoracolumbar Fascia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-26

Study Completion Date

2022-10-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Patients with nonspecific low back pain

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

Group Type EXPERIMENTAL

Massage therapy technique

Intervention Type 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

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Massage therapy technique

Intervention Type 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

Intervention Type 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.

Interventions

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Massage 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.

Intervention Type OTHER

Sham 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes