Neuromuscular Inhibition vs Muscle Energy Techniques With Core Exercises in Mechanical Low Back Pain

NCT ID: NCT07258927

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Mechanical Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized into three parallel groups:

1. CSE + INIT
2. CSE + MET
3. CSE alone.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Core Stabilization Exercise (CSE)

Intervention Type BEHAVIORAL

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.

Integrated Neuromuscular Inhibition Technique (INIT)

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Core Stabilization Exercise (CSE)

Intervention Type BEHAVIORAL

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.

Muscle Energy Technique (MET)

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Core Stabilization Exercise (CSE)

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Core Stabilization Exercise (CSE)

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.

Intervention Type BEHAVIORAL

Integrated Neuromuscular Inhibition Technique (INIT)

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.

Intervention Type BEHAVIORAL

Muscle Energy Technique (MET)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Melek Agırtmış

PT, PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

RÜSTEM MUSTAFAOĞLU

Role: STUDY_DIRECTOR

Istanbul University-Cerrahpaşa - Graduate School of Health Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul University-Cerrahpaşa, Graduate School / Doctoral Program

Istanbul, BAŞAKŞEHİR, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

MELEK AGIRTMIŞ, PT, PhD

Role: CONTACT

+905378434095

RÜSTEM MUSTAFAOĞLU, Assoc, PhD

Role: CONTACT

+905554178535

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

MELEK AGIRTMIŞ, PT, PhD

Role: primary

+905378434095

RÜSTEM MUSTAFAOĞLU, Assoc, PhD

Role: backup

+905554178535

Related Links

Access external resources that provide additional context or updates about the study.

https://www.istanbul.edu.tr/

General study protocol and information, including Istanbul University Cerrahpaşa Ethics Committee approval and protocol details.

https://clinicaltrials.gov/

Official clinical trials registry providing general study information.

https://www.istanbul.edu.tr/

Istanbul University institutional resources and study-related documentation.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IUC-GSHS-2025-INITKET-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Non-Specific Chronic Low Back Pain Treatment Methods
NCT07057687 ACTIVE_NOT_RECRUITING NA