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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Other Experimental Group - Lumbar Stabilization Exercises + PNE
  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 a
• Other Control Group - Lumbar Stabilization Exercises Only
  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 an

Primary outcome measures

• 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).]
• 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).]

Secondary outcome measures (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).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07307859 · Al Azhar University , Gaza

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗