Effects of Thoracolumbar Fascia Myofascial Release in Chronic Low Back Pain

NCT07667062 | Not Yet Recruiting

• 1 other identifier: UHS/USERC-26/SEC/480
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Non-specific Low Back Pain

Keywords

Thoracolumbar fascia; Myofascial release; Chronic low back pain; Fascia thickness; Fascial stiffness; Pain self-efficacy

Outcome Measures

Primary Outcomes (3)

• Thoracolumbar Fascia Thickness

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

  Baseline and 6 weeks

• Thoracolumbar Fascia Stiffness

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

  Baseline and 6 weeks

• 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).

  Baseline and 6 weeks

Secondary Outcomes (4)

• Pain Intensity (Numeric Rating Scale)

  Baseline and 6 weeks

• Functional Disability (Oswestry Disability Index)

  Baseline and 6 weeks

• Lumbar Flexion Range of Motion

  Baseline and 6 weeks

• Patient Global Impression of Change (PGIC)

  6 weeks

Study Arms (2)

Myofascial Release Group

EXPERIMENTAL

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

Behavioral: Myofascial Release of Thoracolumbar Fascia

Sham Myofascial Release Group

SHAM COMPARATOR

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.

Other: Sham Myofascial Release

Interventions

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

Also known as: Crossed-hands Myofascial Release, Thoracolumbar Fascial Release, Manual Fascial Therapy

Myofascial Release Group

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

Also known as: Placebo manual therapy, Light touch intervention, Sham fascial release

Sham Myofascial Release Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

Study Sites (1)

Affiliated Teaching Hospitals of University of Health Sciences Lahore

Lahore, Punjab Province, Pakistan

Location

Related Publications (1)

• Devantery K, Morin M, Grimard J, Gaudreault N. Effects of a Myofascial Technique on the Stiffness and Thickness of the Thoracolumbar Fascia and Lumbar Erector Spinae Muscles in Adults with Chronic Low Back Pain: A Randomized before-and-after Experimental Study. Bioengineering (Basel). 2023 Mar 6;10(3):332. doi: 10.3390/bioengineering10030332.

  PMID: 36978723 BACKGROUND

Central Study Contacts

Manahil Nisar, DPT

CONTACT

03240691766; dr.manahilnisar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to group allocation. Participants and care providers will not be blinded due to the nature of manual therapy intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: June 20, 2026
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)