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NCT Number: NCT07307859

Pain Neuroscience Education Combined With Lumbar Stabilization Exercises on Disability and Kinesiophobia Among Patients With Chronic Low Back Pain

This study will investigate the effect of adding Pain Neuroscience Education (PNE) to a standard lumbar stabilization exercise program on disability and kinesiophobia among patients with chronic low back pain in the Gaza Strip. Participants will be randomly assigned into two groups:

Control group - will receive lumbar stabilization exercises only.

Experimental group - will receive lumbar stabilization exercises in addition to PNE delivered once weekly for 8 sessions.

Both groups will undergo an 8-week intervention, and outcome measures will be collected at baseline, post-intervention (8 weeks), and at a follow-up assessment (16 weeks) to evaluate the persistence of treatment effects. It is expected that the experimental group will show greater improvements in disability and kinesiophobia compared with the control group, indicating that integrating PNE with stabilization exercises may provide enhanced and sustained benefits for patients with chronic low back pain.

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Key information

Conditions

Chronic Low Back Pain

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study will explore whether integrating Pain Neuroscience Education (PNE) with a lumbar stabilization exercise program can produce superior clinical outcomes for individuals with chronic low back pain. The intervention will be delivered over eight weeks, with both groups participating in supervised lumbar stabilization sessions. The experimental group will additionally receive weekly PNE sessions designed to improve pain understanding, modify unhelpful beliefs, and reduce fear-avoidance behaviors.

PNE sessions will focus on explaining the neurophysiological mechanisms of chronic pain, emphasizing concepts such as central sensitization, the protective nature of pain, and the role of thoughts, emotions, and movement in pain modulation. The lumbar stabilization exercises will aim to improve trunk control, enhance spinal stability, and promote functional movement patterns.

Participants will be assessed at baseline, after completion of the intervention period, and again at a later follow-up to examine the sustainability of treatment effects. The study is expected to provide evidence on whether combining educational and physical interventions yields greater improvements in disability and kinesiophobia compared with stabilization exercises alone. This information may support future clinical decision-making and contribute to improving physiotherapy services for patients with chronic low back pain in the Gaza Strip.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 25to 50 years.
  • CLBP lasting for more than 12 weeks.

Exclusion criteria

  • History of spinal surgery or fractures.
  • Presence of neurological problems.
  • Inflammatory conditions, including radiculopathy.
  • Pregnancy.
  • Body mass index (BMI) ≥ 30.
  • Chronic systemic diseases or conditions requiring regular use of strong analgesics or opioids, which may interfere with intervention outcomes.
  • Significant visual or hearing impairments.

Treatment and study plan

Experimental Group - Lumbar Stabilization Exercises + PNE

Other

Experimental Group - Lumbar Stabilization Exercises + PNE

  • Lumbar Stabilization Exercises (LSE)

Frequency: 3 supervised sessions per week for 8 weeks

→ Total 24 supervised LSE sessions

Session duration: 45-60 minutes

Structure each session:

Warm-up (5-10 min)

Core stabilization program (30-40 min)

Cool-down (5-10 min)

Progression: Exercises will advance weekly from basic motor control to high-level functional stabilization (details below).

Home program: 1 additional short home session weekly (basic LSE).

Monitoring: VAS before and after each session. Exercises will be modified if pain rises >2 VAS points.

Adherence: Attendance logs

  • Pain Neuroscience Education (PNE)

Frequency: Once per week (included within one of the 3 weekly sessions)

→ Total 8 PNE sessions

Duration: 30-40 minutes

Format: Small group (≤5) or one-on-one

Methods: Metaphors, storytelling, diagrams, role-play, Arabic handouts

Learning evaluation: Mini-quizzes, reflective journaling, i

Control Group - Lumbar Stabilization Exercises Only

Other

Lumbar Stabilization Exercises (LSE)

Frequency: 3 supervised sessions per week for 8 weeks

→ Total 24 supervised LSE sessions

Session duration: 45-60 minutes

Structure: Identical warm-up, core program, and cool-down as the experimental group.

Progression: Identical 8-week exercise progression.

Home program: 1 basic LSE home session weekly (same as experimental group).

Communication: Therapists will not provide pain education or discuss pain science concepts.

Adherence: Attendance logs and SMS reminders identical to the experimental group.

Primary outcomes

  1. Oswestry Disability Index

    Time frame: Time Frame: Baseline (pre-intervention), immediately post-intervention at 8 weeks, and follow-up at 8 weeks post-intervention (16 weeks from baseline).

    Oswestry Disability Index (ODI) The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category will be followed by six statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5, with the first statement being zero and indicating the least amount of disability. The last statement will score5, showing the most severe 18 disability. The scores for all questions answered are summed and then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability, and

  2. Tampa Scale for Kinesiophobia (TSK)

    Time frame: Time Frame: Baseline (pre-intervention), immediately post-intervention at 8 weeks, and follow-up at 8 weeks post-intervention (16 weeks from baseline).

    The Tampa Scale for Kinesiophobia (TSK) is a widely used, validated self-report questionnaire designed to assess fear of movement and fear-avoidance beliefs in individuals with musculoskeletal pain, particularly chronic low back pain. The scale measures the degree to which a person fears that movement or physical activity may cause pain or lead to reinjury.

    The TSK consists of 17 items, each rated on a 4-point Likert scale ranging from:

    • = Strongly disagree
    • = Disagree
    • = Agree
    • = Strongly agree

    The total score ranges from 17 to 68, with higher scores indicating greater levels of kinesiophobia, meaning stronger fear-avoidance behavior, increased movement-related fear, and greater concern about physical activity causing harm.

Secondary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: Time Frame: Baseline (pre-intervention), immediately post-intervention at 8 weeks, and follow-up at 8 weeks post-intervention (16 weeks from baseline).

    The Visual Analog Scale (VAS) is a widely used and validated tool for assessing subjective pain intensity in both acute and chronic pain conditions. It is simple, sensitive, and responsive to changes in pain, making it suitable for clinical trials and re

Study contacts

Contact information is provided by the study sponsor or research team.

Mosab Aldabbas Last Name or Official Title: Aldabbas First Name: Mosab, PhD

CONTACT

[email protected]

00972597451222

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Effect of Pain Neuroscience Education Combined With Lumbar Stabilization Exercises on Disability and Kinesiophobia Among Patients With Chronic Low Back Pain

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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