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临床试验/NCT07258927
NCT07258927尚未招募不适用

Comparison of the Effects of Integrated Neuromuscular Inhibition and Muscle Energy Techniques Combined With Core Stabilization Exercises in Patients With Chronic Mechanical Low Back Pain

Istanbul University - Cerrahpasa2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
2
主要终点
Pressure Pain Threshold (PPT)

研究概览

简要总结

Chronic mechanical low back pain (CMLBP) is a common clinical problem that affects physical function, spinal mobility, and quality of life. Manual therapy techniques such as Integrated Neuromuscular Inhibition Technique (INIT) and Muscle Energy Technique (MET) are frequently used in clinical practice to reduce pain and improve function. Core stabilization exercises (CSE) have also been reported to enhance spinal stability and neuromuscular control. However, limited evidence exists comparing the combined effects of these manual therapy techniques with core stabilization exercise on clinical outcomes in individuals with CMLBP.

This randomized controlled clinical study aims to compare the effects of CSE combined with INIT and CSE combined with MET on pain intensity, functional disability, lumbar range of motion, psychosocial status, muscle endurance, and quality of life in adults with chronic mechanical low back pain.

Participants will be randomly assigned to one of two groups: (1) CSE + INIT or (2) CSE + MET. Each group will receive treatment two times per week for six weeks. Pain severity, functional status, lumbar mobility, patient-reported outcomes, and muscle endurance will be assessed at baseline, immediately after the intervention, and at follow-up.

The results of this study will help determine whether INIT or MET provides additional benefit when combined with core stabilization exercise for improving symptoms and function in individuals with chronic mechanical low back pain.

详细描述

Chronic mechanical low back pain (CMLBP) is one of the most prevalent musculoskeletal disorders worldwide. It is characterized by pain originating from the lumbar spine or surrounding structures without a specific underlying pathology. The condition often results in pain, functional disability, reduced spinal mobility, impaired muscle performance, and psychosocial effects, which can negatively influence quality of life.

Manual therapy modalities are commonly used in rehabilitation to alleviate symptoms and improve mobility in individuals with CMLBP. The Integrated Neuromuscular Inhibition Technique (INIT) is a multimodal approach that includes strain-counterstrain, trigger point release, and muscle energy technique to reduce muscle tension, deactivate tender points, and improve neuromuscular balance. Muscle Energy Technique (MET) is an osteopathic manual therapy approach that uses voluntary muscle contractions against resistance to relax hypertonic muscles, increase joint mobility, and reduce pain. Both techniques are frequently used in practice, yet their comparative effectiveness when combined with core stabilization exercise remains unclear.

Core Stabilization Exercises (CSE) focus on enhancing the strength, endurance, and motor control of the deep spinal stabilizing muscles. They are widely recommended to improve spinal stability, decrease pain, and enhance function in individuals with CMLBP.

This randomized controlled study aims to evaluate and compare the effectiveness of CSE combined with INIT versus CSE combined with MET on multiple clinical outcomes in individuals with CMLBP. Participants who meet the inclusion criteria will be randomly assigned to one of two intervention groups:

CSE + INIT Group: will receive integrated neuromuscular inhibition techniques along with core stabilization exercises.

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
Single (Outcomes Assessor)

盲法说明

The investigator performing outcome assessments will be blinded to group allocation. Participants and care providers cannot be blinded due to the nature of the interventions.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 18-65
  • Diagnosed chronic mechanical low back pain (>3 months)
  • Pain localized between T12 and gluteal fold
  • Ability to follow exercise instructions
  • Voluntary consent

排除标准

  • Spine surgery history
  • Herniated disc with neurological deficit
  • Systemic neuromuscular or rheumatologic disease
  • Acute lumbar trauma
  • Pregnancy
  • Current participation in another clinical trial
  • Use of analgesics, muscle relaxants, or physiotherapy within the past 4 weeks

结局指标

主要结局

Pressure Pain Threshold (PPT)

时间窗: Baseline, Week 6 (post-treatment)

Pressure pain threshold will be assessed using a handheld pressure algometer at standardized lumbar paraspinal trigger point regions. PPT is defined as the minimum pressure that produces pain. Higher values indicate reduced pain sensitivity. Units of Measure: Kilograms per square centimeter (kg/cm²)

次要结局

  • Disability Level (Oswestry Disability Index)(Baseline, Week 6)

研究者

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

Melek Agırtmış

PT, PhD Student

Istanbul University - Cerrahpasa

研究点 (2)

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