Effects of a Myofascial Technique on Biomechanical Properties of the Lumbar Myofascia of Chronic Low Back Pain Adults
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Myofascial release technique
Simulated Myofascial Release technique
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Low back pain, Fascia properties, Thoracolumbar fascia, Myofascial release, Manual therapy, Osteopathy, Ultrasound imaging, Sonoelastography
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
Sites / Locations
- Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Myofascial release technique group
Simulated myofascial release technique group
Arm Description
Outcomes
Primary Outcome Measures
Changes in elastography features of the myofascial unit
Evaluated with a shear wave sonoelastography device.
Secondary Outcome Measures
Changes in ultrasonography features of the myofascial unit
Evaluated with a B-mode ultrasound imaging device
Changes in myometry features of the myofascial unit
Evaluated with a myotonometer
Changes in pain intensity
Numeric rating Scale (0 to 10; minimum = 0; maximum = 10; higher score means worst outcome)
Full Information
NCT ID
NCT04830566
First Posted
March 19, 2021
Last Updated
October 31, 2022
Sponsor
Université de Sherbrooke
1. Study Identification
Unique Protocol Identification Number
NCT04830566
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
July 8, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Low back pain, Fascia properties, Thoracolumbar fascia, Myofascial release, Manual therapy, Osteopathy, Ultrasound imaging, Sonoelastography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Myofascial release technique group
Arm Type
Experimental
Arm Title
Simulated myofascial release technique group
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Myofascial release technique
Intervention Description
Myofascial technique on the thoracolumbar fascia and lumbar paraspinal muscles
Intervention Type
Other
Intervention Name(s)
Simulated Myofascial Release technique
Intervention Description
Superficial hands contact on the lumbar area
Primary Outcome Measure Information:
Title
Changes in elastography features of the myofascial unit
Description
Evaluated with a shear wave sonoelastography device.
Time Frame
Baseline (before treatment), post-treatment (immediately after treatment)
Secondary Outcome Measure Information:
Title
Changes in ultrasonography features of the myofascial unit
Description
Evaluated with a B-mode ultrasound imaging device
Time Frame
Baseline (before treatment) post-treatment (immediately after treatment)
Title
Changes in myometry features of the myofascial unit
Description
Evaluated with a myotonometer
Time Frame
Baseline (before treatment) post-treatment (immediately after treatment)
Title
Changes in pain intensity
Description
Numeric rating Scale (0 to 10; minimum = 0; maximum = 10; higher score means worst outcome)
Time Frame
Baseline (before treatment) post-treatment (immediately after treatment), at day 2 and at day 7 after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathaly Gaudreault, PhD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mélanie Morin, PhD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Study Director
Facility Information:
Facility Name
Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of a Myofascial Technique on Biomechanical Properties of the Lumbar Myofascia of Chronic Low Back Pain Adults
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