- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07460011
Effects of Pain Neuroscience Education on Pain, Kinesiophobia in Patients With Non Specific Low Back Pain
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maham Khalid
- Phone Number: 03334164339
- Email: mahamkhalid651@gmail.com
Study Locations
-
-
-
Lahore, Pakistan
- Ghurki Trust and Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
-
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pain neuroscience education + core stabilization
Participants receive core stabilization exercises combined with structured pain neuroscience education three times per week for four weeks
|
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.
|
|
Active Comparator: Core stabilisation exercises only
Participants receive core stabilization exercises alone three times per week for four weeks without pain neuroscience education.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
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.
|
4weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kinesiophobia
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. |
4week
|
Collaborators and Investigators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dpt/ERB/49
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Non Specific Low Back Pain
-
Lincoln University CollegeCairo University; Taif UniversityNot yet recruitingNon Specific Low Back Pain
-
Riphah International UniversityCompletedNon Specific Low Back PainPakistan
-
Laval UniversityMedTeq; Corset Saint-FrancisRecruitingNon-specific Low Back PainCanada
-
Bahçeşehir UniversityNot yet recruitingNon-specific Low Back PainTurkey (Türkiye)
-
Bahçeşehir UniversityNot yet recruitingChronic Non-specific Low Back PainTurkey (Türkiye)
-
Kirsehir Ahi Evran UniversitesiRecruitingEffects of Virtual Reality-Assisted Pain Neuroscience Education on Chronic Nonspecific Low Back PainChronic Non-Specific Low Back PainTurkey (Türkiye)
-
University of HailNot yet recruitingNon Specific Chronic Low Back PainSaudi Arabia
-
Maheen RaufRecruitingNon-specific Chronic Low Back PainPakistan
-
University Hospital, MontpellierNot yet recruitingNon-specific Low Back Pain (NSLBP)
-
Ehab Mohamed Kamel AhmedThe Scientific Research Deanship, University of Ha'ilNot yet recruitingNon-specific Low Back Pain (NSLBP)Saudi Arabia
Clinical Trials on Pain neuroscience education + core stabilization
-
Kirsehir Ahi Evran UniversitesiRecruitingEffects of Virtual Reality-Assisted Pain Neuroscience Education on Chronic Nonspecific Low Back PainChronic Non-Specific Low Back PainTurkey (Türkiye)
-
Lahore University of Biological and Applied SciencesNot yet recruiting
-
Universidad Autonoma de MadridUniversidad Rey Juan CarlosRecruiting
-
University of ValenciaCompleted
-
Brooke Army Medical CenterCompletedShoulder PainUnited States
-
University of TartuRecruiting
-
Teesside UniversityCompleted
-
Lisa CarlessoCompletedOsteoarthritis | Chronic PainCanada
-
Wichita State UniversityUniversity of KentuckyCompletedChronic Pain | Opioid DependenceUnited States
-
Universidade Federal de Sao CarlosCompleted