Effects of Thoracolumbar Fascia Myofascial Release in Chronic Low Back Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Health Sciences Lahore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Sham Myofascial Release

    Other intervention

    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

Treatment groups

65 Participants
are divided into 2 treatment groups
Group A: Myofascial Release GroupExperimental treatment 1 intervention
Group B: Sham Myofascial Release GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Thoracolumbar Fascia Thickness

Change in thoracolumbar fascia thickness measured using B-mode ultrasound imaging

Time frame
Baseline and 6 weeks
2

Thoracolumbar Fascia Stiffness

Change in thoracolumbar fascia stiffness measured using shear-wave Sonoelastography.

Time frame
Baseline and 6 weeks
3

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

Secondary outcomes

1

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
2

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
3

Lumbar Flexion Range of Motion

Change in lumbar flexion range of motion measured using the Modified Schober Test.

Time frame
Baseline and 6 weeks
4

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

Other outcomes

Sponsors and contacts

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