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Not yet recruiting Not applicable NCT07551323

Comparison of the Effectiveness of Myofascial Release Technique and Pilates Exercises in Chronic Non-Specific Low Back Pain

No applicable phase (e.g. observational)
Conditions: Chronic Non-specific Low Back Pain

Sponsor: Bahçeşehir University

trial.available_in: БГ
Overview
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.
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).
Who can participate
Inclusion Criteria: * 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 written informed consent Exclusion Criteria: * Systemic, neurological, or orthopedic conditions limiting exercise participation Lumbar radiculopathy or severe spinal pathology (e.g., disc herniation with nerve root compression) 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
Interventions
Myofascial Release Technique (MRT)
OTHER
Sham Myofascial Release Technique
OTHER
Clinical Pilates Exercise
OTHER
Locations 1
Turkey (1)
Bahçeşehir University, Faculty of Health Sciences, Physiotherapy Laboratory
Istanbul , Istanbul
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
45 Years
Healthy volunteers
No
Start date
10.04.2026
Completion date
01.03.2027
Registry ID
NCT07551323
Source
clinicaltrials.gov
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