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Effects of Thoracolumbar Fascia Myofascial Release in Chronic Low Back Pain (TLF-MFR-LBP)

23 juni 2026 bijgewerkt door: Manahil Nisar, University of Health Sciences Lahore

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

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

65

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Myofascial Release Group
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
Gedragsmatig: Myofascial 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
Andere namen:
  • Crossed-hands Myofascial Release
  • Thoracolumbar Fascial Release
  • Manual Fascial Therapy
Sham-vergelijker: Sham Myofascial Release Group
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.
Ander: Sham Myofascial Release
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
Andere namen:
  • Placebo manuele therapie
  • Light touch intervention
  • Sham fascial release

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Thoracolumbar Fascia Thickness
Tijdsspanne: Baseline and 6 weeks
Change in thoracolumbar fascia thickness measured using B-mode ultrasound imaging
Baseline and 6 weeks
Thoracolumbar Fascia Stiffness
Tijdsspanne: Baseline and 6 weeks
Change in thoracolumbar fascia stiffness measured using shear-wave Sonoelastography.
Baseline and 6 weeks
Pain Self-Efficacy (PSEQ)
Tijdsspanne: 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).
Baseline and 6 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain Intensity (Numeric Rating Scale)
Tijdsspanne: 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).
Baseline and 6 weeks
Lumbar Flexion Range of Motion
Tijdsspanne: Baseline and 6 weeks
Change in lumbar flexion range of motion measured using the Modified Schober Test.
Baseline and 6 weeks
Functional Disability (Oswestry Disability Index)
Tijdsspanne: 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)
Baseline and 6 weeks
Patient Global Impression of Change (PGIC)
Tijdsspanne: 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
6 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Health Sciences Lahore

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

20 juni 2026

Primaire voltooiing (Geschat)

1 augustus 2026

Studie voltooiing (Geschat)

1 augustus 2026

Studieregistratiedata

Eerst ingediend

18 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 juni 2026

Eerst geplaatst (Werkelijk)

24 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

23 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • UHS/USERC-26/SEC/480

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared. Data will be retained by the investigators and institution in accordance with ethical and confidentiality requirements

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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