NCT07460011

Brief Summary

Chronic non-specific low back pain (NSLBP) is a highly prevalent musculoskeletal condition and a leading cause of disability worldwide. Psychological factors such as fear-avoidance beliefs and kinesiophobia significantly contribute to pain chronicity, reduced physical activity, and functional limitations. Pain Neuroscience Education (PNE) is a biopsychosocial educational approach designed to reconceptualize pain as a protective output of the nervous system rather than solely a marker of tissue damage. This randomized controlled trial aims to determine the effect of Pain Neuroscience Education combined with Core Stabilization Exercises on pain intensity and kinesiophobia in patients with chronic non-specific low back pain. A total of 62 participants aged 20-55 years with mechanical low back pain lasting ≥3 months will be randomly allocated into two groups: (1) Core Stabilization Exercises plus PNE (experimental group) and (2) Core Stabilization Exercises alone (control group). The intervention duration will be four weeks, with three sessions per week. Primary outcomes include pain intensity measured by the Numeric Pain Rating Scale (NPRS) and kinesiophobia measured using the Fear-Avoidance Beliefs Questionnaire (FABQ). Assessments will be conducted at baseline and post-intervention. The study hypothesizes that the addition of PNE will produce greater reductions in fear-avoidance beliefs and pain intensity compared to exercise therapy alone.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress84%
Mar 2026Sep 2026

Study Start

First participant enrolled

March 2, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2026

Last Updated

March 10, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

March 4, 2026

Last Update Submit

March 4, 2026

Conditions

Keywords

PainKinesiophobiaPain neuroscience educationCore stabilizationNumeric pain rating scaleFear avoidance belief questionnaire

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    The NPRS is an eleven-point pain scale that ranges from 0 to 10. On the scale, zero is labeled as "no pain at all" at the left end, and 10 is labeled as "worst possible pain" at the right end. As a result, larger values indicate more severe pain. The individual is asked to select an integer that best represents the severity of their pain. The NPRS is widely used for pain evaluation in clinical practice and research, with strong test-retest reliability and conceptual construct validity points.

    4weeks

Secondary Outcomes (1)

  • Kinesiophobia

    4week

Study Arms (2)

Pain neuroscience education + core stabilization

EXPERIMENTAL

Participants receive core stabilization exercises combined with structured pain neuroscience education three times per week for four weeks

Other: Pain neuroscience education + core stabilization

Core stabilisation exercises only

ACTIVE COMPARATOR

Participants receive core stabilization exercises alone three times per week for four weeks without pain neuroscience education.

Other: Core stabilization exercises

Interventions

The control group participated in an exercise program which was founded on the principle of FITT. The participants attended 3 sessions a week in a span of four weeks. The sessions were 45 minutes long and occurred at an intermediate intensity, 10 reps per set. In the case of the intervention group, the hot pack application was applied to the area of pain followed by 10 minutes of trans-cutaneous electrical nerve stimulation (TENS) and maitland's grade I and II postero-anterior glide to manage pain. Subsequently, a structured core stabilization exercise program (bridging, bird- dog position, single knee-to-chest, curl-up, and side bridge exercises) was performed by participants

Core stabilisation exercises only

The intervention group met thrice a week in the course of four weeks as the FITT principle dictates. All sessions took 45 minutes and were moderate in their intensity with 10 repetitions per set. The initial treatment was a 10 minutes hot pack application and a 10 minutes trans-cutaneous electrical nerve stimulation (TENS). In addition to these modalities, participants engaged in an organized program of core stabilization exercises and maitland's grade I and II postero-anterior glide to manage pain. CSE included bridging, bird-dog position, single knee-to-chest, curl-ups, and side bridges. Parallel to the exercise component, a structured module of Pain Neuroscience Education (PNE) based on the biopsychosocial model was delivered weekly, focusing on the social, psychological, and physical dimensions of pain and functional recovery.

Pain neuroscience education + core stabilization

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants included in this study were male and female patients aged between 20 and 55 years diagnosed with chronic non-specific low back pain of mechanical origin lasting three months or more.
  • Individuals experiencing pain localized between the costal margin and gluteal folds without radiating symptoms or specific pathological causes were considered eligible.
  • Participants with low back pain that has persisted for more than three months reported pain intensity of greater than three months.
  • The study will involve those who have mechanical low back pain, which is defined as pain that is impacted by posture, movement, and physical activity but does not have a specific cause

You may not qualify if:

  • Participants with a history of spinal fractures, previous spine injury, malignant tumors, spondylolisthesis, or spondylolysis were excluded from this study.
  • The conditions associated with structural instability, neurological involvement, or serious underlying pathology.
  • Individuals with a history of malignant tumors involving the spine were excluded because cancer-related pain.
  • Pregnant women were also excluded from the study due to physiological, hormonal, and bio-mechanical changes that occur during pregnancy, which may alter spinal loading, pain perception, and movement patterns

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghurki trust and teaching hospital

Lahore, Pakistan

Location

MeSH Terms

Conditions

PainKinesiophobia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This study is conducted as a single-blinded randomized controlled trial in which participants are unaware of their group allocation to minimize performance bias. Due to the nature of the physiotherapy and educational interventions, the treating physiotherapist cannot be blinded. Outcome measures are recorded using standardized assessment tools to reduce assessment bias and maintain methodological rigor.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study uses a parallel assignment interventional model in which 62 participants with chronic non-specific low back pain are randomly allocated into two groups. The experimental group receives Core Stabilization Exercises combined with Pain Neuroscience Education, while the control group receives Core Stabilization Exercises alone. Both groups undergo treatment three times per week for four weeks and remain in their assigned groups throughout the study without crossover. The parallel design allows simultaneous comparison of the two interventions while preventing contamination or carryover effects. Outcomes are measured using the Numeric Pain Rating Scale (NPRS) and the Fear-Avoidance Beliefs Questionnaire (FABQ) at baseline and post-intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 10, 2026

Study Start

March 2, 2026

Primary Completion (Estimated)

September 2, 2026

Study Completion (Estimated)

September 2, 2026

Last Updated

March 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations