Effects of Thoracolumbar Fascia Myofascial Release in Chronic Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Myofascial Release of Thoracolumbar Fascia, Sham Myofascial Release.
- Who it may be relevant to
- Registry conditions: Chronic Non-specific Low Back Pain. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Behavioral 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 - Other 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
Primary outcome measures
- Thoracolumbar Fascia Thickness [Time frame: Baseline and 6 weeks]
- Thoracolumbar Fascia Stiffness [Time frame: Baseline and 6 weeks]
- Pain Self-Efficacy (PSEQ) [Time frame: Baseline and 6 weeks]
Secondary outcome measures (4)
- Pain Intensity (Numeric Rating Scale) [Time frame: Baseline and 6 weeks]
- Functional Disability (Oswestry Disability Index) [Time frame: Baseline and 6 weeks]
- Lumbar Flexion Range of Motion [Time frame: Baseline and 6 weeks]
- Patient Global Impression of Change (PGIC) [Time frame: 6 weeks]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Affiliated Teaching Hospitals of University of Health Sciences Lahore — Lahore
Publications
- 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
Identifiers
NCT: NCT07667062 · UHS/USERC-26/SEC/480