Chronic Non-specific Low Back PainTLF-MFR-LBPNCT07667062
Effects of Thoracolumbar Fascia Myofascial Release in Chronic Low Back Pain
A study testing Myofascial Release of Thoracolumbar Fascia in people with Chronic Non-specific Low Back Pain, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Non-specific Low Back Pain
- What is being tested?
- Myofascial Release of Thoracolumbar Fascia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jun 2026to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Affiliated Teaching Hospitals of University of Health Sciences Lahore
Lahore, Punjab Province
Manahil Nisar, DPT, dr.manahilnisar@gmail.com
dr.manahilnisar@gmail.com
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Chronic Non-specific Low Back Pain
- Being tested
- Myofascial Release of Thoracolumbar Fascia, Sham Myofascial Release
- Keywords
- Thoracolumbar fascia, Myofascial release, Chronic low back pain, Fascia thickness, Fascial stiffness, Pain self-efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial Release of Thoracolumbar FasciaBehavioural
Also called Crossed-hands Myofascial Release, Thoracolumbar Fascial Release, Manual Fascial Therapy
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 ReleaseOther
Also called Placebo manual therapy, Light touch intervention, Sham fascial 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Sham Myofascial Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracolumbar Fascia Thickness
Change in thoracolumbar fascia thickness measured using B-mode ultrasound imaging
Measured: Baseline and 6 weeks
Thoracolumbar Fascia Stiffness
Change in thoracolumbar fascia stiffness measured using shear-wave Sonoelastography.
Measured: 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).
Measured: Baseline and 6 weeks
Secondary outcomes (4)
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).
Measured: Baseline and 6 weeks
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)
Measured: Baseline and 6 weeks
Lumbar Flexion Range of Motion
Change in lumbar flexion range of motion measured using the Modified Schober Test.
Measured: Baseline and 6 weeks
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start20 Jun 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Non-specific Low Back PainStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manahil Nisar, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667062
- Sponsor's protocol ID
- UHS/USERC-26/SEC/480
- Acronym
- TLF-MFR-LBP
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Data will be retained by the investigators and institution in accordance with ethical and confidentiality requirements
Publications
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.
PubMed 36978723
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07667062
- Acronym / sponsor ID
- TLF-MFR-LBP / UHS/USERC-26/SEC/480
- Conditions
- Chronic Non-specific Low Back Pain
- Keywords
- Thoracolumbar fascia, Myofascial release, Chronic low back pain, Fascia thickness, Fascial stiffness, Pain self-efficacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 20 Jun 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Myofascial Release Group | Experimental | Behavioral: Myofascial Release of Thoracolumbar FasciaParticipants 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 |
| Sham Myofascial Release Group | Sham comparator | Other: Sham Myofascial ReleaseParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myofascial Release of Thoracolumbar FasciaAlso: Crossed-hands Myofascial Release, Thoracolumbar Fascial Release, Manual Fascial TherapyStandardized 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 | Behavioural | Myofascial Release Group |
| Sham Myofascial ReleaseAlso: Placebo manual therapy, Light touch intervention, Sham fascial releaseSham 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 | Sham Myofascial Release Group |
Primary outcome
Thoracolumbar Fascia Thickness
Time frame: Baseline and 6 weeks
Change in thoracolumbar fascia thickness measured using B-mode ultrasound imaging
Thoracolumbar Fascia Stiffness
Time frame: Baseline and 6 weeks
Change in thoracolumbar fascia stiffness measured using shear-wave Sonoelastography.
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).
4 secondary outcomes
Pain Intensity (Numeric Rating Scale)
Time frame: Baseline and 6 weeks
Functional Disability (Oswestry Disability Index)
Time frame: Baseline and 6 weeks
Lumbar Flexion Range of Motion
Time frame: Baseline and 6 weeks
Patient Global Impression of Change (PGIC)
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Background: PubMed 36978723Devantery 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Data will be retained by the investigators and institution in accordance with ethical and confidentiality requirements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial Release of Thoracolumbar Fascia in people with Chronic Non-specific Low Back Pain, run by University of Health Sciences Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manahil Nisar, DPT (03240691766, dr.manahilnisar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracolumbar Fascia Thickness (time frame: Baseline and 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07667062, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.