Chronic Non-specific Low Back PainNCT07551323
Comparison of the Effectiveness of Myofascial Release Technique and Pilates Exercises in Chronic Non-Specific Low Back Pain
A study testing Myofascial Release Technique (MRT) and Clinical Pilates Exercise in people with Chronic Non-specific Low Back Pain, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Objective: To evaluate the effectiveness of adding Myofascial Release Technique (MRT) to Clinical Pilates in adults with chronic non-specific low back pain (CNSLBP). Hypothesis: MRT combined with Pilates will lead to greater improvements in pain, functional disability, and soft tissue mobility compared to Pilates… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Chronic Non-specific Low Back Pain
- What is being tested?
- Myofascial Release Technique (MRT) and Clinical Pilates Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2026to 1 Mar 2027
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic non-specific low back pain lasting at least 3 months
- No clinical signs of nerve root compression or neurological deficit
- Aged 18-45 years
- No physical therapy or manual therapy for low back pain in the last 1 month
- Pain intensity of at least 3 on the Visual Analog Scale (VAS) in the last week
- Willingness to participate and provide written informed consent
Who cannot join
- Systemic, neurological, or orthopedic conditions limiting exercise participation
- Lumbar radiculopathy or severe spinal pathology
- History of lumbar spine surgery
- Unhealed fracture or recent surgical intervention
- Rheumatologic or inflammatory diseases
- Neurological disorders affecting movement or balance
- Participation in any physiotherapy or rehabilitation program in the last 6 months
- Pregnancy or postpartum period within the last 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cemile Ayşe GÖRMELİ, PhD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bahçeşehir University, Faculty of Health Sciences, Physiotherapy Laboratory
Istanbul, Istanbul, 34353
Zerrin Yılmaz, MSc, +905349279167, zerrin.yilmaz@ou.bau.edu.tr
Cemile Ayşe GÖRMELİ, PhD, cemileayse.gormeli@bau.edu.tr
About this study
Objective:
To evaluate the effectiveness of adding Myofascial Release Technique (MRT) to Clinical Pilates in adults with chronic non-specific low back pain (CNSLBP).
Read more
Hypothesis:
MRT combined with Pilates will lead to greater improvements in pain, functional disability, and soft tissue mobility compared to Pilates alone.
Design \& Intervention:
Randomized controlled trial. Participants (18-45 years) will be randomly assigned to:
MRT + Clinical Pilates Clinical Pilates only for 6 weeks (2 sessions/week).
Outcomes:
Primary: Pain (VAS), ultrasonographic thickness (multifidus \& thoracolumbar fascia) Secondary: Disability (ODI), lumbar mobility, balance
Eligibility:
Adults with CNSLBP ≥3 months; excluding spinal surgery, rheumatic disease, and pregnancy.
Read the detailed description
Rationale Chronic non-specific low back pain (CNSLBP) is associated with structural changes in the thoracolumbar fascia (TLF) and atrophy of the multifidus muscle. While Clinical Pilates enhances core stability, it may not adequately address myofascial densification. This study evaluates whether adding Myofascial Release Technique (MRT) to a Pilates program provides superior improvements in tissue morphology (TLF and multifidus thickness) and clinical outcomes compared to Pilates alone.
Intervention Protocol
A 6-week supervised program (2 sessions/week) will be conducted:
Experimental Group: 20 minutes of manual MRT applied to the thoracolumbar region followed by a standardized Clinical Pilates session focusing on lumbopelvic stabilization.
Control Group: Clinical Pilates program only (Core stabilization exercises: pelvic curls, bird-dog, planks).
Ultrasonographic Assessment
High-resolution musculoskeletal ultrasound will be used for objective analysis at the L3, L4, and L5 vertebral levels (2 cm lateral to the spinous processes):
TLF Thickness: Measurement of the posterior layer of the thoracolumbar fascia.
Multifidus Muscle Thickness: Quantitative measurement of the multifidus muscle thickness and potential hypertrophy post-intervention.
All measurements will be performed by a blinded assessor to ensure the objectivity of the data.
Statistical Plan Comparison: Intra-group changes will be analyzed with Paired t-tests, and inter-group differences with Independent t-tests.
Correlation: Pearson/Spearman tests will assess the relationship between ultrasonographic changes (TLF and multifidus thickness) and clinical improvements (VAS/ODI).
- Conditions
- Chronic Non-specific Low Back Pain
- Being tested
- Myofascial Release Technique (MRT), Sham Myofascial Release Technique, Clinical Pilates Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial Release Technique (MRT)Other
Also called MRT, Manual Myofascial Release
Myofascial Release Technique (MRT) will be applied manually to the lumbar and thoracolumbar regions to improve fascial mobility, reduce soft tissue restrictions, and decrease pain. The technique will be delivered for 6 weeks, 2 sessions per week, by a trained physiotherapist.
Sham Myofascial Release TechniqueOther
Sham Myofascial Release Technique will be applied to the lumbar and thoracolumbar regions using light manual contact without therapeutic pressure or specific myofascial release techniques. The intervention is designed to mimic the real treatment in terms of time and therapist contact, but without producing physiological therapeutic effects. It will be administered for 6 weeks, 2 sessions per week by a trained physiotherapist.
Clinical Pilates ExerciseOther
The Clinical Pilates program will focus on trunk stabilization, core muscle activation, postural control, flexibility, and functional movement training. Exercises will be individually tailored and progressed according to participant tolerance. The program will be administered for 6 weeks, 2 sessions per week under physiotherapist supervision.
| Study group | Role | What they receive |
|---|---|---|
| Sham MRT + Clinical Pilates | Sham comparator | Participants in this group will receive sham myofascial release technique combined with Clinical Pilates exercises. The sham intervention will involve light manual contact without sufficient pressure or technique to produce therapeutic effects. The Clinical Pilates program will be based on core stabilization principles and applied for 6 weeks, 2 sessions per week. Receives: Other: Sham Myofascial Release Technique; Other: Clinical Pilates Exercise |
| MRT + Clinical Pilates | Experimental | Participants in this group will receive Myofascial Release Technique (MRT) combined with a Clinical Pilates exercise program. MRT will be applied to the lumbar and thoracolumbar regions using manual techniques aimed at improving fascial mobility and reducing tissue restriction. The Clinical Pilates program will focus on core stabilization, postural control and flexibility. The intervention will be administered for 6 weeks, 2 sessions per week Receives: Other: Myofascial Release Technique (MRT); Other: Clinical Pilates Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (VAS)
Pain intensity will be measured using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants will mark their current pain level on the scale.
Measured: Baseline and 6 weeks (post-intervention)
Multifidus and Thoracolumbar Fascia Thickness
Muscle and fascia thickness will be measured using ultrasonography to evaluate changes in soft tissue properties in the lumbar region.
Measured: Baseline and 6 weeks (post-intervention)
Secondary outcomes (3)
Functional Disability (Oswestry Disability Index - ODI)
Disability related to low back pain will be assessed using the Oswestry Disability Index (ODI), a validated questionnaire measuring functional limitations in daily activities.
Measured: Baseline and 6 weeks
Lumbar Mobility (Modified Schober Test)
Lumbar flexion mobility will be measured using the Modified Schober Test, which evaluates changes in lumbar spine flexibility.
Measured: Baseline and 6 weeks
Dynamic Balance (Y-Balance Test)
Dynamic balance will be assessed using the Y-Balance Test to evaluate functional stability and postural control.
Measured: Baseline and 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 Apr 2026
- Study start15 Jan 2026
- Primary completion10 Dec 2026 (estimated)
- Study completion1 Mar 2027 (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.
- 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
- Both groups will receive the training for 6 weeks
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zerrin Yilmaz, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551323
- Sponsor's protocol ID
- V12kdmsksm
- Status last verified
- Aug 2026
- First submitted
- 18 Apr 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy and ethical considerations. Data will be used solely for the purposes of this study.
Publications
Ajimsha MS, Al-Mudahka NR, Al-Madzhar JA. Effectiveness of myofascial release: systematic review of randomized controlled trials. J Bodyw Mov Ther. 2015 Jan;19(1):102-12. doi: 10.1016/j.jbmt.2014.06.001. Epub 2014 Jun 13.
PubMed 25603749
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Myofascial Release Technique and Pilates Exercises in Chronic Non-Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT07551323
- Acronym / sponsor ID
- V12kdmsksm
- Conditions
- Chronic Non-specific Low Back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 24 Apr 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.
Objective:
To evaluate the effectiveness of adding Myofascial Release Technique (MRT) to Clinical Pilates in adults with chronic non-specific low back pain (CNSLBP).
Hypothesis:
MRT combined with Pilates will lead to greater improvements in pain, functional disability, and soft tissue mobility compared to Pilates alone.
Design \& Intervention:
Randomized controlled trial. Participants (18-45 years) will be randomly assigned to:
MRT + Clinical Pilates Clinical Pilates only for 6 weeks (2 sessions/week).
Outcomes:
Primary: Pain (VAS), ultrasonographic thickness (multifidus \& thoracolumbar fascia) Secondary: Disability (ODI), lumbar mobility, balance
Eligibility:
Adults with CNSLBP ≥3 months; excluding spinal surgery, rheumatic disease, and pregnancy.
Detailed description
Rationale Chronic non-specific low back pain (CNSLBP) is associated with structural changes in the thoracolumbar fascia (TLF) and atrophy of the multifidus muscle. While Clinical Pilates enhances core stability, it may not adequately address myofascial densification. This study evaluates whether adding Myofascial Release Technique (MRT) to a Pilates program provides superior improvements in tissue morphology (TLF and multifidus thickness) and clinical outcomes compared to Pilates alone.
Intervention Protocol
A 6-week supervised program (2 sessions/week) will be conducted:
Experimental Group: 20 minutes of manual MRT applied to the thoracolumbar region followed by a standardized Clinical Pilates session focusing on lumbopelvic stabilization.
Control Group: Clinical Pilates program only (Core stabilization exercises: pelvic curls, bird-dog, planks).
Ultrasonographic Assessment
High-resolution musculoskeletal ultrasound will be used for objective analysis at the L3, L4, and L5 vertebral levels (2 cm lateral to the spinous processes):
TLF Thickness: Measurement of the posterior layer of the thoracolumbar fascia.
Multifidus Muscle Thickness: Quantitative measurement of the multifidus muscle thickness and potential hypertrophy post-intervention.
All measurements will be performed by a blinded assessor to ensure the objectivity of the data.
Statistical Plan Comparison: Intra-group changes will be analyzed with Paired t-tests, and inter-group differences with Independent t-tests.
Correlation: Pearson/Spearman tests will assess the relationship between ultrasonographic changes (TLF and multifidus thickness) and clinical improvements (VAS/ODI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Both groups will receive the training for 6 weeks
| Arm | Type | Receives |
|---|---|---|
| Sham MRT + Clinical Pilates | Sham comparator | Other: Sham Myofascial Release Technique, Other: Clinical Pilates ExerciseParticipants in this group will receive sham myofascial release technique combined with Clinical Pilates exercises. The sham intervention will involve light manual contact without sufficient pressure or technique to produce therapeutic effects. The Clinical Pilates program will be based on core stabilization principles and applied for 6 weeks, 2 sessions per week. |
| MRT + Clinical Pilates | Experimental | Other: Myofascial Release Technique (MRT), Other: Clinical Pilates ExerciseParticipants in this group will receive Myofascial Release Technique (MRT) combined with a Clinical Pilates exercise program. MRT will be applied to the lumbar and thoracolumbar regions using manual techniques aimed at improving fascial mobility and reducing tissue restriction. The Clinical Pilates program will focus on core stabilization, postural control and flexibility. The intervention will be administered for 6 weeks, 2 sessions per week |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Chronic non-specific low back pain lasting at least 3 months
- No clinical signs of nerve root compression or neurological deficit
- Aged 18-45 years
- No physical therapy or manual therapy for low back pain in the last 1 month
- Pain intensity of at least 3 on the Visual Analog Scale (VAS) in the last week
Key exclusion criteria (8 listed)
- Systemic, neurological, or orthopedic conditions limiting exercise participation
- Lumbar radiculopathy or severe spinal pathology
- History of lumbar spine surgery
- Unhealed fracture or recent surgical intervention
- Rheumatologic or inflammatory diseases
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 Technique (MRT)Also: MRT, Manual Myofascial ReleaseMyofascial Release Technique (MRT) will be applied manually to the lumbar and thoracolumbar regions to improve fascial mobility, reduce soft tissue restrictions, and decrease pain. The technique will be delivered for 6 weeks, 2 sessions per week, by a trained physiotherapist. | Other | MRT + Clinical Pilates |
| Sham Myofascial Release TechniqueSham Myofascial Release Technique will be applied to the lumbar and thoracolumbar regions using light manual contact without therapeutic pressure or specific myofascial release techniques. The intervention is designed to mimic the real treatment in terms of time and therapist contact, but without producing physiological therapeutic effects. It will be administered for 6 weeks, 2 sessions per week by a trained physiotherapist. | Other | Sham MRT + Clinical Pilates |
| Clinical Pilates ExerciseThe Clinical Pilates program will focus on trunk stabilization, core muscle activation, postural control, flexibility, and functional movement training. Exercises will be individually tailored and progressed according to participant tolerance. The program will be administered for 6 weeks, 2 sessions per week under physiotherapist supervision. | Other | MRT + Clinical Pilates, Sham MRT + Clinical Pilates |
Primary outcome
Pain Intensity (VAS)
Time frame: Baseline and 6 weeks (post-intervention)
Pain intensity will be measured using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants will mark their current pain level on the scale.
Multifidus and Thoracolumbar Fascia Thickness
Time frame: Baseline and 6 weeks (post-intervention)
Muscle and fascia thickness will be measured using ultrasonography to evaluate changes in soft tissue properties in the lumbar region.
3 secondary outcomes
Functional Disability (Oswestry Disability Index - ODI)
Time frame: Baseline and 6 weeks
Lumbar Mobility (Modified Schober Test)
Time frame: Baseline and 6 weeks
Dynamic Balance (Y-Balance Test)
Time frame: Baseline and 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 4 Aug 2026.
- Background: PubMed 25603749Ajimsha MS, Al-Mudahka NR, Al-Madzhar JA. Effectiveness of myofascial release: systematic review of randomized controlled trials. J Bodyw Mov Ther. 2015 Jan;19(1):102-12. doi: 10.1016/j.jbmt.2014.06.001. Epub 2014 Jun 13.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy and ethical considerations. Data will be used solely for the purposes of this study.
Related trials for Chronic Non-specific Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
Chronic Low Back Pain (CLBP)
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
McGill Stabilization Exercises Versus Pilates for Chronic Low Back Pain
Chronic Non-Specific Low Back Pain
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.
Cemile Ayşe GÖRMELİ, PhD contact
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 Technique (MRT) and Clinical Pilates Exercise in people with Chronic Non-specific Low Back Pain, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 4 Aug 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 Turkey (Türkiye). 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 Zerrin Yılmaz, MSc (+905349279167, zerrin.yilmaz@ou.bau.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (VAS) (time frame: Baseline and 6 weeks (post-intervention)). The study lists 2 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 NCT07551323, 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 4 Aug 2026.