Non Specific Low Back PainNCT07460011
Effects of Pain Neuroscience Education on Pain, Kinesiophobia in Patients With Non Specific Low Back Pain
A study testing Core stabilization exercises and Pain neuroscience education + core stabilization in people with Non Specific Low Back Pain, run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Non Specific Low Back Pain
- What is being tested?
- Core stabilization exercises and Pain neuroscience education + core stabilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Mar 2026to 2 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Non Specific Low Back Pain
- Being tested
- Core stabilization exercises, Pain neuroscience education + core stabilization
- Keywords
- Pain, Kinesiophobia, Pain neuroscience education, Core stabilization, Numeric pain rating scale, Fear avoidance belief questionnaire
- Medical subject headings
- Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stabilization exercisesOther
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
Pain neuroscience education + core stabilizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pain neuroscience education + core stabilization | Experimental | Participants receive core stabilization exercises combined with structured pain neuroscience education three times per week for four weeks Receives: Other: Pain neuroscience education + core stabilization |
| Core stabilisation exercises only | Active comparator | Participants receive core stabilization exercises alone three times per week for four weeks without pain neuroscience education. Receives: Other: Core stabilization exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
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.
Measured: 4weeks
Secondary outcomes (1)
Kinesiophobia
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.
Measured: 4week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start2 Mar 2026 (estimated)
- Primary completion2 Sep 2026 (estimated)
- Study completion2 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Specific Low Back PainStudies of the same condition, open and under way.
- More trials run by Lahore University of Biological and Applied SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel assignment interventional model in which 62 participants with chronic non-specific low back pain are randomly allocated into two groups. The experimental group receives Core Stabilization Exercises combined with Pain Neuroscience Education, while the control group receives Core Stabilization Exercises alone. Both groups undergo treatment three times per week for four weeks and remain in their assigned groups throughout the study without crossover. The parallel design allows simultaneous comparison of the two interventions while preventing contamination or carryover effects. Outcomes are measured using the Numeric Pain Rating Scale (NPRS) and the Fear-Avoidance Beliefs Questionnaire (FABQ) at baseline and post-intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Hufsa Tariq, Lahore University of Biological and Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460011
- Sponsor's protocol ID
- Dpt/ERB/49
- Status last verified
- Feb 2026
- First submitted
- 4 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pain Neuroscience Education on Pain, Kinesiophobia in Patients With Non Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT07460011
- Acronym / sponsor ID
- Dpt/ERB/49
- Conditions
- Non Specific Low Back Pain
- Keywords
- Pain, Kinesiophobia, Pain neuroscience education, Core stabilization, Numeric pain rating scale, Fear avoidance belief questionnaire
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Lahore University of Biological and Applied SciencesUniversity, hospital or other
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- 2 Sep 2026 (estimated)
- Study completion
- 2 Sep 2026 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study uses a parallel assignment interventional model in which 62 participants with chronic non-specific low back pain are randomly allocated into two groups. The experimental group receives Core Stabilization Exercises combined with Pain Neuroscience Education, while the control group receives Core Stabilization Exercises alone. Both groups undergo treatment three times per week for four weeks and remain in their assigned groups throughout the study without crossover. The parallel design allows simultaneous comparison of the two interventions while preventing contamination or carryover effects. Outcomes are measured using the Numeric Pain Rating Scale (NPRS) and the Fear-Avoidance Beliefs Questionnaire (FABQ) at baseline and post-intervention.
| Arm | Type | Receives |
|---|---|---|
| Pain neuroscience education + core stabilization | Experimental | Other: Pain neuroscience education + core stabilizationParticipants receive core stabilization exercises combined with structured pain neuroscience education three times per week for four weeks |
| Core stabilisation exercises only | Active comparator | Other: Core stabilization exercisesParticipants receive core stabilization exercises alone three times per week for four weeks without pain neuroscience education. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- -
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core stabilization exercisesThe 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 | Other | Core stabilisation exercises only |
| Pain neuroscience education + core stabilizationThe 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. | Other | Pain neuroscience education + core stabilization |
Primary outcome
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.
1 secondary outcome
Kinesiophobia
Time frame: 4week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stabilization exercises and Pain neuroscience education + core stabilization in people with Non Specific Low Back Pain, run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maham Khalid (03334164339, mahamkhalid651@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 4weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.