NCT07202533

Brief Summary

This study aims to evaluate the effects of adding Pain Neuroscience Education (PNE) to motor control exercises in individuals with chronic non-specific low back pain (CNSLBP) who also present with central sensitization. The study focuses on changes in pain intensity, pain-related factors, trunk muscle activation, gait, functionality, kinesiophobia, and quality of life.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2025

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 2, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

February 20, 2026

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

September 2, 2025

Last Update Submit

February 19, 2026

Conditions

Keywords

low back paincentral sensitizationsurface electromyographypain neuroscience educationmotor control exercise

Outcome Measures

Primary Outcomes (6)

  • Pain Intensity (Numerical Pain Rating Scale - NPRS)

    Change in pain intensity will be assessed using a 0-10 Numerical Pain Rating Scale at baseline and post-intervention. Higher scores indicate greater pain severity.

    Baseline and post-intervention (8 weeks)

  • Pressure Paın Threshold Measurement

    PPT will be measured using a digital algometer on the lumbar region. Higher values indicate reduced pain sensitivity.

    Baseline and post-intervention (8 weeks)

  • Central Sensitization (Central Sensitization Inventory - CSI)

    The CSI-A section will be used to evaluate symptoms related to central sensitization. Total scores range from 0-100, with higher scores indicating greater sensitization.

    Baseline and post-intervention (8 weeks)

  • Pain Knowledge (Revised Neurophysiology of Pain Questionnaire - rNPQ)

    Participants' knowledge about pain neurophysiology will be assessed. The number of correct responses will be calculated.

    Baseline and post-intervention (8 weeks)

  • Disability (Roland-Morris Disability Questionnaire - RMDQ)

    Functional disability due to low back pain will be assessed using the RMDQ, a 24-item self-report questionnaire.

    Baseline and post-intervention (8 weeks)

  • Muscle Activation (Surface EMG Analysis)

    Surface EMG will evaluate activation levels of bilateral external oblique, internal oblique, transversus abdominis, and tibialis anterior muscles during gait.

    Baseline and post-intervention (8 weeks)

Secondary Outcomes (5)

  • Kinesiophobia (Tampa Scale for Kinesiophobia - TSK)

    Baseline and post-intervention (8 weeks)

  • Pain Catastrophizing (Pain Catastrophizing Scale - PCS)

    Baseline and post-intervention (8 weeks)

  • Gait Analysis (OptoGait Photocell System)

    Baseline and post-intervention (8 weeks)

  • Gait Analysis (Noraxon Ultium Insole)

    Baseline and post-intervention (8 weeks)

  • Quality of Life (Nottingham Health Profile - NHP)

    Baseline and post-intervention (8 weeks)

Study Arms (2)

Motor Control Exercises

ACTIVE COMPARATOR

This group will receive motor control exercises only.

Other: Motor Control Exercises

Motor Control Exercises + Pain Neuroscience Education

EXPERIMENTAL

This group will receive the same motor control exercise program as the control group, plus a 6-week PNE program delivered once per week. The PNE program consists of 6 weekly sessions, delivered via slide presentations and interactive discussions, covering topics such as nociception, central sensitization, neuroplasticity, and pain coping strategies. Sessions are delivered by a certified physiotherapist.

Other: Pain Neuroscience EducationOther: Motor Control Exercises

Interventions

Participants will perform these exercises under physiotherapist supervision twice per week for 8 weeks. Exercises focus on improving deep trunk muscle coordination and stability.

Motor Control Exercises

A 6-week educational program with weekly sessions using slide presentations and interactive discussions, covering pain neurophysiology, central sensitization, and pain coping strategies, delivered by a certified physiotherapist.

Motor Control Exercises + Pain Neuroscience Education

Eligibility Criteria

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

You may qualify if:

  • Volunteers who agree to participate in the study
  • Having a history of non-specific low back pain lasting at least 3 months
  • Having a pain intensity score of 3 or higher on the Numerical Pain Rating Scale (NPRS) within the last week
  • Scoring ≥28 on the Turkish version of the Central Sensitization Inventory.

You may not qualify if:

  • Individuals with radicular symptoms or cauda equina syndrome
  • Severe osteoporosis
  • Spondyloarthropathy
  • Spondylolisthesis
  • Lumbar spinal stenosis
  • Lumbar fractures
  • Malignant tumors
  • Severe comorbidities (neurological, neuromuscular, cardiac, or psychiatric disorders)
  • Individuals who have undergone spinal surgery
  • Individuals who are familiar with motor control exercises or who have previously received pain neuroscience education

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Karabük Province, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either a control group receiving motor control exercises or an intervention group receiving motor control exercises plus PNE. Both groups will receive treatment twice weekly for 8 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
→ PhD Candidate, Research Assistant

Study Record Dates

First Submitted

September 2, 2025

First Posted

October 1, 2025

Study Start

August 29, 2024

Primary Completion

August 8, 2025

Study Completion

March 31, 2026

Last Updated

February 20, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations