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

Sponsor

Université de Sherbrooke (Other)

Overall Status

Recruiting

CT.gov ID

NCT04830566

Collaborator

(none)

Enrollment

Location

Arms

4.4

Anticipated Duration (Months)

10.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Low Back Pain	Other: Myofascial release technique Other: Simulated Myofascial Release technique	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 19, 2021

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Changes in elastography features of the myofascial unit [Baseline (before treatment), post-treatment (immediately after treatment)]
Evaluated with a shear wave sonoelastography device.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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