Chronic Non-specific Low Back Pain
Conditions
Keywords
Thoracolumbar fascia, Myofascial release, Chronic low back pain, Fascia thickness, Fascial stiffness, Pain self-efficacy
Brief summary
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
BEHAVIORALMyofascial 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 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
Sponsors
University of Health Sciences Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blinded to group allocation. Participants and care providers will not be blinded due to the nature of manual therapy intervention.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thoracolumbar Fascia Thickness | Baseline and 6 weeks | Change in thoracolumbar fascia thickness measured using B-mode ultrasound imaging |
| Thoracolumbar Fascia Stiffness | Baseline and 6 weeks | Change in thoracolumbar fascia stiffness measured using shear-wave Sonoelastography. |
| Pain Self-Efficacy (PSEQ) | Baseline and 6 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity (Numeric Rating Scale) | Baseline and 6 weeks | 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). |
| Functional Disability (Oswestry Disability Index) | Baseline and 6 weeks | 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) |
| Lumbar Flexion Range of Motion | Baseline and 6 weeks | Change in lumbar flexion range of motion measured using the Modified Schober Test. |
| Patient Global Impression of Change (PGIC) | 6 weeks | 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 |
Countries
Pakistan
Contacts
CONTACTManahil Nisar, DPT
Outcome results
None listed