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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myofascial Release Technique (MRT) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline and 6 weeks (post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 weeks |
| Lumbar Mobility (Modified Schober Test) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zerrin Yılmaz, MSc | Contact | +905349279167 | zerrin.yilmaz@ou.bau.edu.tr | |
| Cemile Ayşe GÖRMELİ, PhD | Contact | cemileayse.gormeli@bau.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bahçeşehir University, Faculty of Health Sciences, Physiotherapy Laboratory | Istanbul | Istanbul | 34353 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25603749 | Background | 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. |
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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.
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Both groups will receive the training for 6 weeks
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|
| Sham Myofascial Release Technique | Other | 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 Exercise | Other | 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. |
|
Lumbar flexion mobility will be measured using the Modified Schober Test, which evaluates changes in lumbar spine flexibility. |
| 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. | Baseline and 6 weeks |
| ID | Term |
|---|---|
| D000089803 | Myofascial Release Therapy |
| ID | Term |
|---|---|
| D008405 | Massage |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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