Bahçeşehir University, Faculty of Health Sciences, Physiotherapy Laboratory
Istanbul, 34353, Turkey (Türkiye)
Location contact
Cemile Ayşe GÖRMELİ, PhD
CONTACT
Zerrin Yılmaz, MSc
CONTACT
Zerrin Yılmaz, MSc
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07551323
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.
Trial opening soon.
Get Notified18 year–45 year
All sexes
Interventional
Not applicable
Istanbul, 34353, Turkey (Türkiye)
Cemile Ayşe GÖRMELİ, PhD
CONTACT
Zerrin Yılmaz, MSc
CONTACT
Zerrin Yılmaz, MSc
PRINCIPAL_INVESTIGATOR
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: MRT, Manual Myofascial Release
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.
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.
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.
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.
Time frame: Baseline and 6 weeks
Disability related to low back pain will be assessed using the Oswestry Disability Index (ODI), a validated questionnaire measuring functional limitations in daily activities.
Time frame: Baseline and 6 weeks
Lumbar flexion mobility will be measured using the Modified Schober Test, which evaluates changes in lumbar spine flexibility.
Time frame: Baseline and 6 weeks
Dynamic balance will be assessed using the Y-Balance Test to evaluate functional stability and postural control.
Contact information is provided by the study sponsor or research team.
Cemile Ayşe GÖRMELİ, PhD
CONTACT
Zerrin Yılmaz, MSc
CONTACT
Bahçeşehir University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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