Effects of a Myofascial Technique on Biomechanical Properties of the Lumbar Myofascia of Chronic Low Back Pain Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Other: Myofascial release technique; Other: Simulated Myofascial Release technique

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Myofascial release technique group	Other: Myofascial release technique; Myofascial technique on the thoracolumbar fascia and lumbar paraspinal muscles
SHAM_COMPARATOR: Simulated myofascial release technique group	Other: Simulated Myofascial Release technique; Superficial hands contact on the lumbar area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in elastography features of the myofascial unit	Evaluated with a shear wave sonoelastography device.	Baseline (before treatment), post-treatment (immediately after treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in ultrasonography features of the myofascial unit	Evaluated with a B-mode ultrasound imaging device	Baseline (before treatment) post-treatment (immediately after treatment)
Changes in myometry features of the myofascial unit	Evaluated with a myotonometer	Baseline (before treatment) post-treatment (immediately after treatment)
Changes in pain intensity	Numeric rating Scale (0 to 10; minimum = 0; maximum = 10; higher score means worst outcome)	Baseline (before treatment) post-treatment (immediately after treatment), at day 2 and at day 7 after the intervention

Collaborators and Investigators

• Sponsor: Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 19, 2021
• Primary Completion (ACTUAL): July 8, 2022
• Study Completion (ACTUAL): July 15, 2022

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (ACTUAL): April 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Low back pain; Ultrasound imaging; Myofascial release; Manual therapy; Osteopathy; Thoracolumbar fascia; Sonoelastography; Fascia properties
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2021-3572

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No