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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Non-specific Low Back Pain
• Intervention / Treatment: Other: Sham Myofascial Release Technique; Other: Clinical Pilates Exercise; Other: Myofascial Release Technique (MRT)

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zerrin Yılmaz, MSc; Phone Number: +905349279167; Email: zerrin.yilmaz@ou.bau.edu.tr
• Study Contact Backup: Name: Cemile Ayşe GÖRMELİ, PhD; Email: cemileayse.gormeli@bau.edu.tr

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34353
      • Bahçeşehir University, Faculty of Health Sciences, Physiotherapy Laboratory
      • Contact: Zerrin Yılmaz, MSc; Phone Number: +905349279167; Email: zerrin.yilmaz@ou.bau.edu.tr
      • Contact: Cemile Ayşe GÖRMELİ, PhD; Email: cemileayse.gormeli@bau.edu.tr
      • Principal Investigator: Zerrin Yılmaz, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 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.	Other: 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.; Other: 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.
Experimental: 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	Other: 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.; Other: 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.; Other Names: MRT; Manual Myofascial Release

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Bahçeşehir University

Publications and helpful links

General Publications

• Ajimsha MS, Al-Mudahka NR, Al-Madzhar JA. Effectiveness of myofascial release: systematic review of randomized controlled trials. Journal of Bodywork and Movement Therapies. 2015;19(1):102-112.

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2026
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 18, 2026
• First Submitted That Met QC Criteria: April 18, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Therapy, Soft Tissue; Musculoskeletal Manipulations; Massage; Myofascial Release Therapy
• Other Study ID Numbers: V12kdmsksm

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No