ClinicalTrials.Veeva

Menu

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

B

Bahçeşehir University

Status

Not yet enrolling

Conditions

Chronic Non-specific Low Back Pain

Treatments

Other: Sham Myofascial Release Technique
Other: Myofascial Release Technique (MRT)
Other: Clinical Pilates Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT07551323
V12kdmsksm

Details and patient eligibility

About

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.

Full 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).

Enrollment

30 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

Sham MRT + Clinical Pilates
Sham Comparator group
Description:
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.
Treatment:
Other: Clinical Pilates Exercise
Other: Sham Myofascial Release Technique
MRT + Clinical Pilates
Experimental group
Description:
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
Treatment:
Other: Clinical Pilates Exercise
Other: Myofascial Release Technique (MRT)

Trial contacts and locations

1

Loading...

Central trial contact

Cemile Ayşe GÖRMELİ, PhD; Zerrin Yılmaz, MSc

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems