跳至主要内容
临床试验/NCT07551323
NCT07551323招募中不适用

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

Bahçeşehir University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
Pain Intensity (VAS)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Sham Myofascial Release Technique (Other)

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.

干预措施: Clinical Pilates Exercise (Other)

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

干预措施: Myofascial Release Technique (MRT) (Other)

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

干预措施: Clinical Pilates Exercise (Other)

结局指标

主要结局

Pain Intensity (VAS)

时间窗: Baseline and 6 weeks (post-intervention)

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.

Multifidus and Thoracolumbar Fascia Thickness

时间窗: Baseline and 6 weeks (post-intervention)

Muscle and fascia thickness will be measured using ultrasonography to evaluate changes in soft tissue properties in the lumbar region.

次要结局

  • 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)

研究者

发起方
Bahçeşehir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zerrin Yilmaz

Physiotherapist, PhD Candidate

Bahçeşehir University

研究点 (2)

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