Effects of Thoracolumbar Fascia Myofascial Release in Chronic Low Back Pain

Официальное название

Effects of Myofascial Release Targeting the Thoracolumbar Fascia on Fascial Morphology, Functional Outcomes, and Pain Self-Efficacy in Adults With Chronic Non-Specific Low Back Pain: A Randomized Controlled Trial

Обзор

The thoracolumbar fascia (TLF) is thickened and stiffer in individuals with chronic non-specific low back pain (CNSLBP) and may contribute to pain persistence. Myofascial release (MFR) has been shown to reduce TLF stiffness acutely; however, its longer-term effects on fascial morphology and pain self-efficacy remain unclear. This randomized controlled trial will investigate the effects of a standardized 6-week MFR program targeting the thoracolumbar fascia compared with sham MFR in adults with CNSLBP. A total of 65 participants aged 18-60 years with CNSLBP will be randomized in a 1:1 ratio to either standardized MFR or sham MFR. The intervention will consist of 18 treatment sessions delivered over 6 weeks. Primary outcomes include thoracolumbar fascia thickness measured by B-mode ultrasound, thoracolumbar fascia stiffness measured by shear-wave elastography, and pain self-efficacy measured using the Pain Self-Efficacy Questionnaire (PSEQ). Secondary outcomes include pain intensity, functional disability, lumbar flexion range of motion, and patient global impression of change. Outcomes will be assessed at baseline and after completion of the 6-week intervention period.

Подробное описание

Chronic non-specific low back pain (CNSLBP) is associated with structural and mechanical alterations of the thoracolumbar fascia (TLF), including increased thickness and stiffness. These changes may contribute to persistent pain and functional limitations. Myofascial release (MFR) is a manual therapy intervention designed to improve fascial mobility and reduce tissue stiffness; however, its effects on TLF morphology and related clinical outcomes remain incompletely understood.

This randomized controlled trial will evaluate the effects of a standardized 6-week myofascial release program targeting the thoracolumbar fascia in adults with chronic non-specific low back pain. Participants will be randomly assigned in a 1:1 ratio to either a myofascial release group or a sham myofascial release group.

Primary outcomes include thoracolumbar fascia thickness measured using B-mode ultrasound, thoracolumbar fascia stiffness measured using shear-wave elastography, and pain self-efficacy measured using the Pain Self-Efficacy Questionnaire. Secondary outcomes include pain intensity, disability, lumbar flexion range of motion, and patient global impression of change. Assessments will be performed at baseline and after completion of the 6-week intervention period.

The study aims to determine whether targeted myofascial release can modify thoracolumbar fascia morphology and improve clinical and psychosocial outcomes in individuals with chronic non-specific low back pain.

Вмешательства

• Поведенческое Myofascial Release of Thoracolumbar Fascia
  Standardized myofascial release targeting the thoracolumbar fascia will be administered over 18 sessions across 6 weeks (3 sessions per week). Each session will last approximately 40 minutes and will involve sustained low-load manual pressure using a crossed-hands technique applied bilaterally at L2-L3 and L4-L5 regions. The intervention aims to reduce fascial stiffness and improve tissue mobility. Treatment will be delivered by a trained physiotherapist following a standardized protocol. No add
• Другое Sham Myofascial Release
  Sham myofascial release will be applied over the same anatomical regions as the experimental group using light manual contact (\<50 g force) without therapeutic pressure or fascial engagement. Sessions will be matched in duration (approximately 40 minutes), frequency (3 sessions per week), and total duration (6 weeks, 18 sessions). The aim is to control for placebo effects, therapist attention, and patient expectation

Первичные конечные точки

• Thoracolumbar Fascia Thickness [Срок оценки: Baseline and 6 weeks]
• Thoracolumbar Fascia Stiffness [Срок оценки: Baseline and 6 weeks]
• Pain Self-Efficacy (PSEQ) [Срок оценки: Baseline and 6 weeks]

Вторичные конечные точки (4)

• Pain Intensity (Numeric Rating Scale) [Срок оценки: Baseline and 6 weeks]
• Functional Disability (Oswestry Disability Index) [Срок оценки: Baseline and 6 weeks]
• Lumbar Flexion Range of Motion [Срок оценки: Baseline and 6 weeks]
• Patient Global Impression of Change (PGIC) [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• Adults aged 18-60 years
• Non-specific low back pain duration > 12 weeks
• Average pain intensity NRS ≥ 3 over the past week
• Able to provide written informed consent
• Able to attend 18 supervised sessions over 6 weeks (3 sessions/week)

Критерии исключения

• Specific spinal pathology (fracture, disc herniation with neurological deficit, spinal stenosis, inflammatory arthropathy, malignancy)
• Previous lumbar surgery
• Current pregnancy
• Severe psychiatric disorder or active psychosis
• Manual therapy or physiotherapy for LBP within the previous 3 months
• Systemic connective tissue disorder (e.g., Ehlers-Danlos syndrome, Marfan syndrome)
• Contraindication to ultrasound imaging or manual therapy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Affiliated Teaching Hospitals of University of Health Sciences Lahore — Lahore

Публикации

• Devantery K, Morin M, Grimard J, Gaudreault N. Effects of a Myofascial Technique on the Stiffness and Thickness of the Thoracolumbar Fascia and Lumbar Erector Spinae Muscles in Adults with Chronic Low Back Pain: A Randomized before-and-after Experimental Study. Bioengineering (Basel). 2023 Mar 6;10(3):332. doi: 10.3390/bioengineering10030332. PMID 36978723

Идентификаторы

NCT: NCT07667062 · UHS/USERC-26/SEC/480

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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