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

NCT07307859 | Not Yet Recruiting DMC

• 1 other identifier: Al Azhar University , Gaza
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Low Back Pain

Keywords

pain neuroscience; lumbar stabilization; disability

Outcome Measures

Primary Outcomes (2)

• Oswestry Disability Index

  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

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

• Tampa Scale for Kinesiophobia (TSK)

  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: 1. = Strongly disagree 2. = Disagree 3. = Agree 4. = 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.

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

Secondary Outcomes (1)

• Visual Analog Scale (VAS)

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

Study Arms (2)

Lumbar Stabilization Exercises

ACTIVE COMPARATOR

Standard Lumbar Stabilization Exercise Program A physiotherapy program focused solely on core and trunk stabilization exercises without additional educational components.

Other: Control Group - Lumbar Stabilization Exercises Only

Lumbar Stabilization Exercises Plus Pain Neuroscience Education

EXPERIMENTAL

Lumbar Stabilization Program Integrated with Weekly Pain Neuroscience Education Sessions A combined intervention including trunk stabilization exercises supported by once-weekly educational sessions addressing pain mechanisms and fear-avoidance beliefs.

Other: Experimental Group - Lumbar Stabilization Exercises + PNE

Interventions

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.

Lumbar Stabilization Exercises

Experimental Group - Lumbar Stabilization Exercises + PNE OTHER

Experimental Group - Lumbar Stabilization Exercises + PNE 1. 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 2. 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

Lumbar Stabilization Exercises Plus Pain Neuroscience Education

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Central Study Contacts

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

CONTACT

00972597451222; mosab.m.aldabbas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor at Al Azhar University ,Palestine, Gaza

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 29, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share