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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myofascial Release Group | Experimental | Participants in this group will receive standardized myofascial release targeting the thoracolumbar fascia. The intervention will consist of 18 sessions over 6 weeks (3 sessions per week), each lasting approximately 40 minutes. The technique involves sustained low-load manual pressure using a crossed-hands approach applied to bilateral L2-L3 and L4-L5 regions of the thoracolumbar fascia. Treatment will be delivered by a trained physiotherapist following a standardized protocol. No additional physiotherapy interventions will be provided during the study period |
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| Sham Myofascial Release Group | Sham Comparator | Participants in this group will receive sham myofascial release targeting the same anatomical regions as the experimental group. Light manual contact (<50 g force) will be applied without therapeutic pressure or fascial engagement. The session duration and frequency will be identical to the experimental group (18 sessions over 6 weeks, 3 sessions per week, approximately 40 minutes per session). Participants will receive identical positioning and therapist contact time to control for placebo and attention effects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myofascial Release of Thoracolumbar Fascia | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Thoracolumbar Fascia Thickness | Change in thoracolumbar fascia thickness measured using B-mode ultrasound imaging | Baseline and 6 weeks |
| Thoracolumbar Fascia Stiffness | Change in thoracolumbar fascia stiffness measured using shear-wave Sonoelastography. | 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). | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and 6 weeks |
| Functional Disability (Oswestry Disability Index) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manahil Nisar, DPT | Contact | 03240691766 | dr.manahilnisar@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Teaching Hospitals of University of Health Sciences Lahore | Lahore | Punjab Province | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36978723 | Background | 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. |
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Individual participant data will not be shared. Data will be retained by the investigators and institution in accordance with ethical and confidentiality requirements
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This is a two-arm, parallel-group randomized controlled trial in which participants will be allocated in a 1:1 ratio to either a standardized myofascial release intervention targeting the thoracolumbar fascia or a sham myofascial release control group. Outcomes will be assessed at baseline and post-intervention.
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Outcome assessors will be blinded to group allocation. Participants and care providers will not be blinded due to the nature of manual therapy intervention.
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| Sham Myofascial Release | Other | 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 |
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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) |
| Baseline and 6 weeks |
| Lumbar Flexion Range of Motion | Change in lumbar flexion range of motion measured using the Modified Schober Test. | 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 | 6 weeks |