NCT07258927

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Apr 2025Dec 2026

Study Start

First participant enrolled

April 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

November 18, 2025

Last Update Submit

March 28, 2026

Conditions

Keywords

Chronic mechanical low back painIntegrated neuromuscular inhibition techniqueRespiratory muscle strengthCore stabilization exercisesMuscle energy technique

Outcome Measures

Primary Outcomes (1)

  • Pressure Pain Threshold (PPT)

    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 Outcomes (1)

  • Disability Level (Oswestry Disability Index)

    Baseline, Week 6

Other Outcomes (4)

  • Trunk Flexor Muscle Endurance

    Baseline, Week 6

  • Respiratory Muscle Strength

    Baseline, 6 week

  • Modified Schober Test

    Baseline, Week 6 (post-treatment)

  • +1 more other outcomes

Study Arms (3)

Core Stabilization + INIT

EXPERIMENTAL

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.

Behavioral: Core Stabilization Exercise (CSE)Behavioral: Integrated Neuromuscular Inhibition Technique (INIT)

Core Stabilization + MET

ACTIVE COMPARATOR

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.

Behavioral: Core Stabilization Exercise (CSE)Behavioral: Muscle Energy Technique (MET)

Core Stabilization Only

ACTIVE COMPARATOR

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.

Behavioral: Core Stabilization Exercise (CSE)

Interventions

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.

Core Stabilization + INITCore Stabilization + METCore Stabilization Only

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 + INIT

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 + MET

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa, Graduate School / Doctoral Program

Istanbul, BAŞAKŞEHİR, 34490, Turkey (Türkiye)

Location

Related Links

Study Officials

  • RÜSTEM MUSTAFAOĞLU

    Istanbul University-Cerrahpaşa - Graduate School of Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized into three parallel groups: 1. CSE + INIT 2. CSE + MET 3. CSE alone.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PhD Student

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 2, 2025

Study Start

April 1, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations