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NCT Number: NCT07667062

Effects of Thoracolumbar Fascia Myofascial Release in Chronic Low Back Pain

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.

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Key information

Conditions

Chronic Non-Specific Low Back Pain

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Teaching Hospitals of University of Health Sciences Lahore

Lahore, Punjab Province, Pakistan

Location contact

Manahil Nisar, DPT

CONTACT

[email protected]

Manahil Nisar, DPT

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Crossed-hands Myofascial Release, Thoracolumbar Fascial Release, Manual Fascial Therapy

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

Other names: Placebo manual therapy, Light touch intervention, Sham fascial release

Primary outcomes

  1. Thoracolumbar Fascia Thickness

    Time frame: Baseline and 6 weeks

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

  2. Thoracolumbar Fascia Stiffness

    Time frame: Baseline and 6 weeks

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

  3. Pain Self-Efficacy (PSEQ)

    Time frame: 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 outcomes

  1. Pain Intensity (Numeric Rating Scale)

    Time frame: 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).

  2. Functional Disability (Oswestry Disability Index)

    Time frame: 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)

  3. Lumbar Flexion Range of Motion

    Time frame: Baseline and 6 weeks

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

  4. Patient Global Impression of Change (PGIC)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Manahil Nisar, DPT

CONTACT

[email protected]

03240691766

Sponsors and collaborators

Lead sponsor

University of Health Sciences Lahore

Other

Registry information

Official study 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

Acronym: TLF-MFR-LBP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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