Comparison of the Effectiveness of Myofascial Release Technique and Pilates Exercises in Chronic Non-Specific Low Back Pain
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Bahçeşehir University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Pain Intensity (VAS)
Overview
Brief 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 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Sham MRT + Clinical Pilates
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.
Intervention: Sham Myofascial Release Technique (Other)
Sham MRT + Clinical Pilates
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.
Intervention: Clinical Pilates Exercise (Other)
MRT + Clinical Pilates
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
Intervention: Myofascial Release Technique (MRT) (Other)
MRT + Clinical Pilates
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
Intervention: Clinical Pilates Exercise (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Functional Disability (Oswestry Disability Index - ODI)(Baseline and 6 weeks)
- Lumbar Mobility (Modified Schober Test)(Baseline and 6 weeks)
- Dynamic Balance (Y-Balance Test)(Baseline and 6 weeks)
Investigators
Zerrin Yilmaz
PhD.(C)
Bahçeşehir University