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临床试验/NCT07460011
NCT07460011尚未招募不适用

Effects of Pain Neuroscience Education on Pain, Kinesiophobia in Patients With Non Specific Low Back Pain

Lahore University of Biological and Applied Sciences1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2026年3月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
Pain intensity

研究概览

简要总结

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.

详细描述

Chronic non-specific low back pain (NSLBP) accounts for approximately 85-90% of low back pain cases and is a major contributor to global disability, often persisting beyond three months without a clearly identifiable pathological cause. In addition to physical impairments, psychosocial factors such as catastrophizing, stress, poor sleep, and fear of movement play a critical role in pain chronicity and functional limitation. Traditional physiotherapy management focuses primarily on biomechanical correction and muscle strengthening; however, contemporary evidence supports a biopsychosocial model addressing cognitive and emotional contributors to pain. Pain Neuroscience Education (PNE) is an evidence-based intervention that educates patients about central sensitization, neuroplasticity, and the multidimensional nature of pain to reduce maladaptive beliefs and kinesiophobia. This single-blinded, parallel-group randomized controlled trial will enroll 62 participants aged 20-55 years diagnosed with chronic mechanical NSLBP and randomly allocate them to either an experimental group receiving Core Stabilization Exercises combined with weekly structured PNE sessions or a control group receiving Core Stabilization Exercises alone for four weeks. Both groups will receive standard physiotherapy modalities as required. Primary outcomes include pain intensity measured by the Numeric Pain Rating Scale (NPRS) and kinesiophobia measured using the Fear-Avoidance Beliefs Questionnaire (FABQ), assessed at baseline and post-intervention. Data will be analyzed using appropriate parametric tests with statistical significance set at p < 0.05. The study aims to determine whether integrating biopsychosocial education into conventional physiotherapy enhances psychological and clinical outcomes in patients with chronic NSLBP and supports long-term functional recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Pain neuroscience education + core stabilization

Experimental

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

干预措施: Pain neuroscience education + core stabilization (Other)

Core stabilisation exercises only

Active Comparator

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

干预措施: Core stabilization exercises (Other)

结局指标

主要结局

Pain intensity

时间窗: 4weeks

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.

次要结局

  • Kinesiophobia(4week)

研究者

发起方
Lahore University of Biological and Applied Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Hufsa Tariq

Assistant professor

Lahore University of Biological and Applied Sciences

研究点 (1)

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