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

NCT04830566 | Completed

• 1 other identifier: 2021-3572
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

Low back pain; Fascia properties; Thoracolumbar fascia; Myofascial release; Manual therapy; Osteopathy; Ultrasound imaging; Sonoelastography

Outcome Measures

Primary Outcomes (1)

• Changes in elastography features of the myofascial unit

  Evaluated with a shear wave sonoelastography device.

  Baseline (before treatment), post-treatment (immediately after treatment)

Secondary Outcomes (3)

• Changes in ultrasonography features of the myofascial unit

  Baseline (before treatment) post-treatment (immediately after treatment)

• Changes in myometry features of the myofascial unit

  Baseline (before treatment) post-treatment (immediately after treatment)

• Changes in pain intensity

  Baseline (before treatment) post-treatment (immediately after treatment), at day 2 and at day 7 after the intervention

Study Arms (2)

Myofascial release technique group

EXPERIMENTAL

Other: Myofascial release technique

Simulated myofascial release technique group

SHAM COMPARATOR

Other: Simulated Myofascial Release technique

Interventions

Myofascial release technique OTHER

Myofascial technique on the thoracolumbar fascia and lumbar paraspinal muscles

Myofascial release technique group

Simulated Myofascial Release technique OTHER

Superficial hands contact on the lumbar area

Simulated myofascial release technique group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Nathaly Gaudreault, PhD

  Université de Sherbrooke

  STUDY DIRECTOR

• Mélanie Morin, PhD

  Université de Sherbrooke

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research director

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: April 5, 2021
• Study Start: March 19, 2021
• Primary Completion: July 8, 2022
• Study Completion: July 15, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-10

Locations

CA (1)