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

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое Myofascial 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.
• Другое Sham Myofascial Release Technique
  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.
• Другое Clinical Pilates Exercise
  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.

Первичные конечные точки

• Pain Intensity (VAS) [Срок оценки: Baseline and 6 weeks (post-intervention)]
• Multifidus and Thoracolumbar Fascia Thickness [Срок оценки: Baseline and 6 weeks (post-intervention)]

Вторичные конечные точки (3)

• Functional Disability (Oswestry Disability Index - ODI) [Срок оценки: Baseline and 6 weeks]
• Lumbar Mobility (Modified Schober Test) [Срок оценки: Baseline and 6 weeks]
• Dynamic Balance (Y-Balance Test) [Срок оценки: Baseline and 6 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Bahçeşehir University, Faculty of Health Sciences, Physiotherapy Laboratory — Istanbul

Публикации

• 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. PMID 25603749

Идентификаторы

NCT: NCT07551323 · V12kdmsksm

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗