Chronic Non-specific Low Back Pain
Conditions
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).
Interventions
OTHERMyofascial Release Technique (MRT)
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 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.
Sponsors
Bahçeşehir University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Both groups will receive the training for 6 weeks
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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 provide written informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity (VAS) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional Disability (Oswestry Disability Index - ODI) | 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. |
| Lumbar Mobility (Modified Schober Test) | Baseline and 6 weeks | Lumbar flexion mobility will be measured using the Modified Schober Test, which evaluates changes in lumbar spine flexibility. |
| Dynamic Balance (Y-Balance Test) | Baseline and 6 weeks | Dynamic balance will be assessed using the Y-Balance Test to evaluate functional stability and postural control. |
Countries
Turkey (Türkiye)
Contacts
CONTACTZerrin Yılmaz, MSc
CONTACTCemile Ayşe GÖRMELİ, PhD
Outcome results
None listed