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

NCT07551323 | Not Yet Recruiting

• 1 other identifier: V12kdmsksm
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Non-specific Low Back Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Functional Disability (Oswestry Disability Index - ODI)

  Baseline and 6 weeks

• Lumbar Mobility (Modified Schober Test)

  Baseline and 6 weeks

• Dynamic Balance (Y-Balance Test)

  Baseline and 6 weeks

Study Arms (2)

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.

Other: Sham Myofascial Release Technique; Other: Clinical Pilates Exercise

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

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

Interventions

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.

Also known as: MRT, Manual Myofascial Release

MRT + Clinical Pilates

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.

Sham MRT + Clinical Pilates

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.

MRT + Clinical Pilates; Sham MRT + Clinical Pilates

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Bahçeşehir University, Faculty of Health Sciences, Physiotherapy Laboratory

Istanbul, Istanbul, 34353, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Interventions

Myofascial Release Therapy

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Zerrin Yılmaz, MSc

CONTACT

+905349279167; zerrin.yilmaz@ou.bau.edu.tr

Cemile Ayşe GÖRMELİ, PhD

CONTACT

cemileayse.gormeli@bau.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, PhD Candidate

Model Details: Both groups will receive the training for 6 weeks

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: April 24, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)