- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07258927
Neuromuscular Inhibition vs Muscle Energy Techniques With Core Exercises in Mechanical Low Back Pain
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
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.
Study Overview
Status
Conditions
Detailed Description
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.
CSE + MET Group: will receive muscle energy techniques along with core stabilization exercises.
Both groups will receive treatment twice weekly for six weeks. Outcome measures will include:
Pain intensity (e.g., Visual Analog Scale)
Functional disability (e.g., Oswestry Disability Index)
Lumbar range of motion
Muscle endurance
Psychosocial status
Quality of life
Assessments will be conducted at three time points: baseline, post-treatment, and follow-up.
The primary hypothesis is that both treatment approaches will lead to improvements in pain and function, but the combination of CSE with INIT may demonstrate superior outcomes compared to CSE with MET.
The findings of this study will provide valuable knowledge to clinicians regarding optimal manual therapy integration with exercise for individuals with chronic mechanical low back pain. This may contribute to evidence-based clinical decision-making and improved patient outcomes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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BAŞAKŞEHİR
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Istanbul, BAŞAKŞEHİR, Turkey (Türkiye), 34490
- Istanbul University-Cerrahpaşa, Graduate School / Doctoral Program
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Core Stabilization + INIT
Participants receive Core Stabilization Exercises (CSE) combined with Integrated Neuromuscular Inhibition Technique (INIT).
Sessions are administered by a physiotherapist, 45-60 minutes per session, 3 times per week for 6 weeks.
INIT includes ischemic compression, strain-counterstrain, and muscle energy techniques applied to active trigger points.
|
Supervised core stabilization exercise program focusing on activation of deep trunk stabilizers (transversus abdominis and multifidus).
Training includes isolated activation, quadruped exercises, bridging variations, and functional stabilization drills.
Sessions last 45-60 minutes, 3 times per week for 6 weeks and are delivered by a physiotherapist.
Manual therapy combining ischemic compression, strain-counterstrain, and muscle energy techniques applied to active trigger points in the lumbar/pelvic region.
Target muscles include quadratus lumborum, iliopsoas, hamstrings, and erector spinae.
Sessions last 45-60 minutes with integrated exercise, 3 times per week for 6 weeks and are administered by a physiotherapist.
|
|
Active Comparator: Core Stabilization + MET
Participants receive Core Stabilization Exercises (CSE) combined with Muscle Energy Technique (MET) delivered by a physiotherapist, 45-60 minutes per session, 3 times per week for 6 weeks.
Manual techniques target trigger points of quadratus lumborum, iliopsoas, hamstring, and erector spinae muscles.
|
Supervised core stabilization exercise program focusing on activation of deep trunk stabilizers (transversus abdominis and multifidus).
Training includes isolated activation, quadruped exercises, bridging variations, and functional stabilization drills.
Sessions last 45-60 minutes, 3 times per week for 6 weeks and are delivered by a physiotherapist.
Manual technique using therapist-guided isometric contraction of shortened muscles followed by relaxation and passive stretch.
Target muscles include quadratus lumborum, iliopsoas, hamstrings, and erector spinae.
Sessions last 45-60 minutes with integrated exercise, 3 times per week for 6 weeks and are administered by a physiotherapist.
|
|
Active Comparator: Core Stabilization Only
Participants perform only Core Stabilization Exercises (CSE), emphasizing activation of deep stabilizers (transversus abdominis and multifidus) with progressive exercises performed under physiotherapist supervision, 45-60 minutes per session, 3 times per week for 6 weeks.
|
Supervised core stabilization exercise program focusing on activation of deep trunk stabilizers (transversus abdominis and multifidus).
Training includes isolated activation, quadruped exercises, bridging variations, and functional stabilization drills.
Sessions last 45-60 minutes, 3 times per week for 6 weeks and are delivered by a physiotherapist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure Pain Threshold (PPT)
Time Frame: Baseline, Week 6 (post-treatment)
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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) |
Baseline, Week 6 (post-treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disability Level (Oswestry Disability Index)
Time Frame: Baseline, Week 6
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Functional disability will be measured using the Oswestry Disability Index (ODI). Scores range from 0-100%, with higher scores indicating greater disability. Outcome Measure: Disability Level (Oswestry Disability Index) Functional disability will be assessed using the Oswestry Disability Index (ODI). The ODI score ranges from 0 to 100 points, with higher scores indicating greater disability and lower scores indicating less disability. The ODI evaluates a participant's level of functional impairment due to low back pain, including activities such as: Pain intensity Personal care Lifting Walking Sitting Standing Sleeping Sex life Units of Measure: Percent (%) Social life Traveling |
Baseline, Week 6
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk Flexor Muscle Endurance
Time Frame: Baseline, Week 6
|
Trunk flexor endurance will be evaluated using a standardized trunk flexor isometric hold test. Time (seconds) is recorded; longer duration indicates better endurance. Units of Measure: Seconds |
Baseline, Week 6
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Respiratory Muscle Strength
Time Frame: Baseline, 6 week
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Respiratory muscle strength will be assessed using a digital manometer measuring maximal inspiratory (MIP) and expiratory (MEP) pressures. Higher values indicate greater respiratory muscle strength. Units of Measure: cmH₂O |
Baseline, 6 week
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Modified Schober Test
Time Frame: Baseline, Week 6 (post-treatment)
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Lumbar flexion mobility will be assessed using the Modified Schober Test. A mark is placed on the lumbar spine and the distance change during maximal forward flexion is measured. Higher values indicate greater lumbar spine mobility. Units of Measure: Centimeters (cm) |
Baseline, Week 6 (post-treatment)
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Lumbar Range of Motion (ROM)
Time Frame: Baseline, Week 6 (post-treatment)
|
Lumbar flexion, extension, lateral flexion will be measured using a digital inclinometer.
Higher values indicate greater mobility.
Units of Measure: Degrees
|
Baseline, Week 6 (post-treatment)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: RÜSTEM MUSTAFAOĞLU, Istanbul University-Cerrahpaşa - Graduate School of Health Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IUC-GSHS-2025-INITKET-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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