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

23. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

65

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Atferdsmessig: 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
Andre navn:
  • Crossed-hands Myofascial Release
  • Thoracolumbar Fascial Release
  • Manual Fascial Therapy
Sham-komparator: 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.
Annen: 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
Andre navn:
  • Placebo manuell terapi
  • Light touch intervention
  • Sham fascial release

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain Intensity (Numeric Rating Scale)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Health Sciences Lahore

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

20. juni 2026

Primær fullføring (Antatt)

1. august 2026

Studiet fullført (Antatt)

1. august 2026

Datoer for studieregistrering

Først innsendt

18. juni 2026

Først innsendt som oppfylte QC-kriteriene

18. juni 2026

Først lagt ut (Faktiske)

24. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • UHS/USERC-26/SEC/480

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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