Clinical trial NCT04830566: Effects of a Myofascial Technique on Biomechanical Properties of the Lumbar Myofascia of Chronic Low Back Pain Adults
Official title: Effects of a Myofascial Technique on Biomechanical Properties of the Lumbar Paraspinal Muscle and Thoracolumbar Fascia in Chronic Low Back Pain Adults Assessed by Elastography, Ultrasonography and Myometry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Low back pain
Fascia properties
Thoracolumbar fascia
Myofascial release
Manual therapy
Osteopathy
Ultrasound imaging
Sonoelastography
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-specific low back pain is a worldwide health issue that remains poorly understood. Some authors have shown that the thoracolumbar fascia of low back pain adults presents changes in biomechanical properties. As it is richly endowed with pain receptors, the thoracolumbar fascia could therefore be a key contributor to this chronic pain condition. Myofascial techniques (MFTs) are commonly used in manual therapy by practitioners of various backgrounds to address fascia biomechanical properties, but there is a paucity of objective evidence on their effects on tissue state. Musculoskeletal ultrasonography, sonoelastography and myometry are emerging imaging techniques that can quantify the biomechanical properties of fascia and underlying muscle. These innovative techniques could in turn contribute to a better understanding of MFTs effects on fascial properties.

The main objective of this study is to evaluate the immediate effect of a standardized MFT on the elastography features of the lumbar paraspinal muscle and fascia (i.e. myofascial unit). The secondary objectives are to evaluate the immediate effects of a MFT on: i) ultrasonography features of the myofascial unit; ii) myometry features of the myofascial unit; ii) pain intensity.


Eligibility criteria: Inclusion Criteria:

* adults over 18 years of age,
* lumbar pain and/or referred pain above or below the gluteal fold , with intensity \> 3/10, persisting for \> 6 months and presenting during the day \> 50% of the time.

Exclusion Criteria:

* history of serious spinal or lower extremity injury or surgery in the last year
* identifiable back pain or known pathology
* known rheumatological condition
* oral or injectable corticosteroids in the lumbar spine within the last 3 months
* psychiatric disorder
* pregnancy
* manual treatment of the lumbo-sacral region 1 month prior to the experimentation and during the week of the study

Primary outcomes:
measure: Changes in elastography features of the myofascial unit
timeFrame: Baseline (before treatment), post-treatment (immediately after treatment)
Secondary outcomes:
measure: Changes in ultrasonography features of the myofascial unit
timeFrame: Baseline (before treatment) post-treatment (immediately after treatment)
measure: Changes in myometry features of the myofascial unit
timeFrame: Baseline (before treatment) post-treatment (immediately after treatment)
measure: Changes in pain intensity
timeFrame: Baseline (before treatment) post-treatment (immediately after treatment), at day 2 and at day 7 after the intervention
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Nathaly Gaudreault, PhD
role: STUDY_DIRECTOR
affiliation: Université de Sherbrooke
name: Mélanie Morin, PhD
role: STUDY_DIRECTOR
References: