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Completed

NCT Number: NCT04830566

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myofascial Release Technique

Other

Myofascial technique on the thoracolumbar fascia and lumbar paraspinal muscles

Simulated Myofascial Release technique

Other

Superficial hands contact on the lumbar area

Primary outcomes

  1. Changes in elastography features of the myofascial unit

    Time frame: Baseline (before treatment), post-treatment (immediately after treatment)

    Evaluated with a shear wave sonoelastography device.

Secondary outcomes

  1. Changes in ultrasonography features of the myofascial unit

    Time frame: Baseline (before treatment) post-treatment (immediately after treatment)

    Evaluated with a B-mode ultrasound imaging device

  2. Changes in myometry features of the myofascial unit

    Time frame: Baseline (before treatment) post-treatment (immediately after treatment)

    Evaluated with a myotonometer

  3. Changes in pain intensity

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2021
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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