Ghurki trust and teaching hospital
Lahore, Pakistan
NCT Number: NCT07460011
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 opening soon.
Get Notified20 year–55 year
All sexes
Interventional
Not applicable
Lahore, Pakistan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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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
Exclusion criteria
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
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
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.
Time frame: 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.
Time frame: 4week
The Fear-Avoidance Beliefs Questionnaire (FABQ) is an instrument designed to assess the extent to which fear of pain contributes to avoidance behaviors in individuals with low back pain. Such fear-avoidance patterns can result in reduced physical activity and work participation, ultimately aggravating both the physical and psychological burden of pain.
The FABQ consists of 16 items, each rated on a 7-point Likert scale ranging from 0 completely disagree to 6 completely agree.
Contact information is provided by the study sponsor or research team.
Lahore University of Biological and Applied Sciences
Other
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