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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
65
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 additional physiotherapy interventions will be provided during the study period
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
Affiliated Teaching Hospitals of University of Health Sciences Lahore
Lahore, Punjab Province, Pakistan
Thoracolumbar Fascia Thickness
Change in thoracolumbar fascia thickness measured using B-mode ultrasound imaging
Time frame: Baseline and 6 weeks
Thoracolumbar Fascia Stiffness
Change in thoracolumbar fascia stiffness measured using shear-wave Sonoelastography.
Time frame: Baseline and 6 weeks
Pain Self-Efficacy (PSEQ)
Change in pain self-efficacy measured using the Pain Self-Efficacy Questionnaire (PSEQ), a 10-item questionnaire assessing confidence in performing activities despite pain. Total scores range from 0 to 60, with higher scores indicating better pain self-efficacy (greater confidence in functioning despite pain).
Time frame: Baseline and 6 weeks
Pain Intensity (Numeric Rating Scale)
Change in pain intensity measured using the 11-point Numeric Rating Scale (NRS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: Baseline and 6 weeks
Functional Disability (Oswestry Disability Index)
Functional disability will be assessed using the Oswestry Disability Index (ODI). Total scores range from 0 to 100, with higher scores indicating greater disability (worse functional status)
Time frame: Baseline and 6 weeks
Lumbar Flexion Range of Motion
Change in lumbar flexion range of motion measured using the Modified Schober Test.
Time frame: Baseline and 6 weeks
Patient Global Impression of Change (PGIC)
Participant-reported overall perception of improvement following the intervention, assessed using the Patient Global Impression of Change (PGIC) scale. The PGIC is a 7-point scale ranging from 1 to 7, where 1 = very much worse and 7 = very much improved. Higher scores indicate greater perceived improvement and a better outcome
Time frame: 6 weeks
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