- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07284407
Effects of Pain Neuroscience Education With Sensory Discrimination Training Among Patients With Chronic Low Back Pain
Effects of Pain Neuroscience Education With Sensory Discrimination Training on Pain Catastrophizing, Kinesiophobia and Functional Movements Among Patients With Chronic Low Back Pain: A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Chronic low back pain is a complex condition influenced by biological, psychological, and sensory factors. Pain Neuroscience Education has been shown to reduce maladaptive pain beliefs and improve pain processing, while Sensory Discrimination Training targets altered cortical representation that frequently occurs in chronic pain conditions. Combining these approaches may offer a complementary effect by addressing both cognitive and sensory dimensions of pain.
This study will evaluate the added value of Sensory Discrimination Training when delivered alongside Pain Neuroscience Education and core stability exercises, compared with a control intervention combining Pain Neuroscience Education, and core stability exercises. The trial uses a double-blind, parallel-group randomized controlled design with a total of 80 participants diagnosed with chronic low back pain.
Participants will be randomly assigned to one of two intervention groups. The experimental group will receive structured Pain Neuroscience Education sessions, Sensory Discrimination Training using surface-based tactile discrimination tasks, and a standardized core stability exercise program. The comparison group will receive the same Pain Neuroscience Education protocol, and the same core stability exercise program. Both interventions will be provided twice per week for eight weeks, with each session lasting 45 minutes.
The study aims to investigate whether the addition of Sensory Discrimination Training results in greater improvements in pain-related cognitions, fear-related movement avoidance, and functional movement performance. The primary mechanism of interest is the potential effect of Sensory Discrimination Training on improving cortical sensory mapping, which may contribute to reduced pain catastrophising and improved motor function. Outcome measures will be assessedat baseline, 4, and 8 weeks (end of intervention). The current study will be conducted at Nutricao Lahore Clinic and Model Town Hospital Lahore under standardized procedures to ensure intervention fidelity and consistent delivery across sessions.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: MUHAMMAD TARIQ RAFIQ, PhD
- Email: tariq.rafiq@ubas.edu.pk
Study Contact Backup
- Name: MUHAMMAD SAAD JANJUA
- Phone Number: +923167995435
- Email: ubs24lmspt023@ubas.edu.pk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age: 19 to 44 Both Genders Mechanical low back pain (duration more than 6 months and less than 2 years) >4/10 Numerical Pain Rating Scale (NPRS)
Exclusion Criteria:
- Pregnancy or post-partum Trauma Psychological Pain Radicular Pain Cancer, tumor, malignancy Neurological Deficit Recent Surgery <1year
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Participants in the experimental group will receive a 45-minute intervention session consisting of three integrated components (Pain Neuroscience Education, Core Stability Exercises and Graded Sensory Discrimination Training )
|
Other: Pain Neuroscience Education with Sensory Discrimination Training and Core Stability Exercises
Although both Pain Neuroscience Education and Sensory Discrimination Training have demonstrated potential benefits individually, there is a paucity of research evaluating their combined effects.
Integrating cognitive (PNE) and sensorimotor (SDT) approaches may produce synergistic effects, improving pain modulation, functional capacity, and psychological resilience.
|
|
Active Comparator: Control group
Participants in the control group will receive the same 45-minute sessions consisting of two components (Pain Neuroscience Education and Core Stability Exercises).
|
Participants in the control group will receive the same 45-minute sessions twice per week, but will not receive sensory discrimination training.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Catastrophizing
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Pain catastrophizing refers to a maladaptive cognitive and emotional response to actual or perceived pain.
Pain Catastrophizing is measured by the Pain Catastrophizing Scale.
The Pain Catastrophizing Scale is a validated questionnaire used to measure the degree of catastrophic thinking in individuals experiencing pain (Sullivan et al. 1995).
The scale consists of 13 items, each representing a different catastrophizing response.
For each item, participants rate their experience using a 5-point Likert scale, where 0 = Not at all (the thought or feeling never occurred) and 4 = All the time (the thought or feeling occurred persistently).
The total score ranges from 0 to 52, with higher scores indicating greater levels of pain catastrophizing.
|
From enrollment to the end of treatment at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kinesiophobia
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Kinesiophobia is a debilitating fear of movement and physical activity due to the belief that movement will cause pain or re-injury.
Kinesiophobia is measured by the Tampa Scale for Kinesiophobia.
Tampa Scale for Kinesiophobia is the most widely used and validated tool to assess the fear of movement or re-injury.
It contains 17 items.
Each item is scored using a 4-point Likert scale with 1 = strongly disagree and 4 = strongly agree.
Total score ranges from 17 to 68, with higher scores indicating greater kinesiophobia.
|
From enrollment to the end of treatment at 8 weeks
|
|
Functional Movements
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Functional movement refers to the basic movements that people need in daily life to perform normal activities safely and efficiently.
These movements involve multiple joints and muscle groups working together in a coordinated way.
Functional movements will be assessed using 2D motion analysis through the Kinovea software.
Participants will perform two standardized tasks: forward bending and sit-to-stand.
All movements will be recorded using a fixed camera positioned at a consistent height (e.g., 1.2 m) and distance (e.g., 2.5 m) from the participant.
Kinovea will be used to extract trunk flexion angle, lumbar deviation from the midline, pelvic tilt angle and task completion time.
Higher movement quality, reduced deviation, and faster task completion will be interpreted as improved functional performance.
|
From enrollment to the end of treatment at 8 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Muhammad Tariq Rafiq, Lahore University of Biological & Applied Sciences
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UBAS/ERB/FoRS/25/028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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