Chronic Low Back PainNCT07307859
Pain Neuroscience Education Combined With Lumbar Stabilization Exercises on Disability and Kinesiophobia Among Patients With Chronic Low Back Pain
A study testing Experimental Group - Lumbar Stabilization Exercises + PNE in people with Chronic Low Back Pain, run by Al-Azhar University.
Trial summary
This study will investigate the effect of adding Pain Neuroscience Education (PNE) to a standard lumbar stabilization exercise program on disability and kinesiophobia among patients with chronic low back pain in the Gaza Strip. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Experimental Group - Lumbar Stabilization Exercises + PNE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to 1 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 25to 50 years.
- CLBP lasting for more than 12 weeks.
Who cannot join
- History of spinal surgery or fractures.
- Presence of neurological problems.
- Inflammatory conditions, including radiculopathy.
- Pregnancy.
- Body mass index (BMI) ≥ 30.
- Chronic systemic diseases or conditions requiring regular use of strong analgesics or opioids, which may interfere with intervention outcomes.
- Significant visual or hearing impairments.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mosab Aldabbas Last Name or Official Title: Aldabbas First Name: Mosab, PhD contact
About this study
Official title: Effect of Pain Neuroscience Education Combined With Lumbar Stabilization Exercises on Disability and Kinesiophobia Among Patients With Chronic Low Back Pain
This study will investigate the effect of adding Pain Neuroscience Education (PNE) to a standard lumbar stabilization exercise program on disability and kinesiophobia among patients with chronic low back pain in the Gaza Strip. Participants will be randomly assigned into two groups:
Control group - will receive lumbar stabilization exercises only.
Read more
Experimental group - will receive lumbar stabilization exercises in addition to PNE delivered once weekly for 8 sessions.
Both groups will undergo an 8-week intervention, and outcome measures will be collected at baseline, post-intervention (8 weeks), and at a follow-up assessment (16 weeks) to evaluate the persistence of treatment effects. It is expected that the experimental group will show greater improvements in disability and kinesiophobia compared with the control group, indicating that integrating PNE with stabilization exercises may provide enhanced and sustained benefits for patients with chronic low back pain.
Read the detailed description
This study will explore whether integrating Pain Neuroscience Education (PNE) with a lumbar stabilization exercise program can produce superior clinical outcomes for individuals with chronic low back pain. The intervention will be delivered over eight weeks, with both groups participating in supervised lumbar stabilization sessions. The experimental group will additionally receive weekly PNE sessions designed to improve pain understanding, modify unhelpful beliefs, and reduce fear-avoidance behaviors.
PNE sessions will focus on explaining the neurophysiological mechanisms of chronic pain, emphasizing concepts such as central sensitization, the protective nature of pain, and the role of thoughts, emotions, and movement in pain modulation. The lumbar stabilization exercises will aim to improve trunk control, enhance spinal stability, and promote functional movement patterns.
Participants will be assessed at baseline, after completion of the intervention period, and again at a later follow-up to examine the sustainability of treatment effects. The study is expected to provide evidence on whether combining educational and physical interventions yields greater improvements in disability and kinesiophobia compared with stabilization exercises alone. This information may support future clinical decision-making and contribute to improving physiotherapy services for patients with chronic low back pain in the Gaza Strip.
- Conditions
- Chronic Low Back Pain
- Being tested
- Experimental Group - Lumbar Stabilization Exercises + PNE, Control Group - Lumbar Stabilization Exercises Only
- Keywords
- pain neuroscience, lumbar stabilization, disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Group - Lumbar Stabilization Exercises + PNEOther
Experimental Group - Lumbar Stabilization Exercises + PNE
- Lumbar Stabilization Exercises (LSE) Frequency: 3 supervised sessions per week for 8 weeks → Total 24 supervised LSE sessions Session duration: 45-60 minutes Structure each session: Warm-up (5-10 min) Core stabilization program (30-40 min) Cool-down (5-10 min) Progression: Exercises will advance weekly from basic motor control to high-level functional stabilization (details below). Home program: 1 additional short home session weekly (basic LSE). Monitoring: VAS before and after each session. Exercises will be modified if pain rises >2 VAS points. Adherence: Attendance logs
- Pain Neuroscience Education (PNE)
Frequency: Once per week (included within one of the 3 weekly sessions)
→ Total 8 PNE sessions
Duration: 30-40 minutes
Format: Small group (≤5) or one-on-one
Methods: Metaphors, storytelling, diagrams, role-play, Arabic handouts
Learning evaluation: Mini-quizzes, reflective journaling, i
Control Group - Lumbar Stabilization Exercises OnlyOther
Lumbar Stabilization Exercises (LSE)
Frequency: 3 supervised sessions per week for 8 weeks
→ Total 24 supervised LSE sessions
Session duration: 45-60 minutes
Structure: Identical warm-up, core program, and cool-down as the experimental group.
Progression: Identical 8-week exercise progression.
Home program: 1 basic LSE home session weekly (same as experimental group).
Communication: Therapists will not provide pain education or discuss pain science concepts.
Adherence: Attendance logs and SMS reminders identical to the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Stabilization Exercises | Active comparator | Standard Lumbar Stabilization Exercise Program A physiotherapy program focused solely on core and trunk stabilization exercises without additional educational components. Receives: Other: Control Group - Lumbar Stabilization Exercises Only |
| Lumbar Stabilization Exercises Plus Pain Neuroscience Education | Experimental | Lumbar Stabilization Program Integrated with Weekly Pain Neuroscience Education Sessions A combined intervention including trunk stabilization exercises supported by once-weekly educational sessions addressing pain mechanisms and fear-avoidance beliefs. Receives: Other: Experimental Group - Lumbar Stabilization Exercises + PNE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
Oswestry Disability Index (ODI) The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category will be followed by six statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5, with the first statement being zero and indicating the least amount of disability. The last statement will score5, showing the most severe 18 disability. The scores for all questions answered are summed and then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability, and
Measured: Time Frame: Baseline (pre-intervention), immediately post-intervention at 8 weeks, and follow-up at 8 weeks post-intervention (16 weeks from baseline).
Tampa Scale for Kinesiophobia (TSK)
The Tampa Scale for Kinesiophobia (TSK) is a widely used, validated self-report questionnaire designed to assess fear of movement and fear-avoidance beliefs in individuals with musculoskeletal pain, particularly chronic low back pain. The scale measures the degree to which a person fears that movement or physical activity may cause pain or lead to reinjury.
The TSK consists of 17 items, each rated on a 4-point Likert scale ranging from:
- = Strongly disagree
- = Disagree
- = Agree
- = Strongly agree
The total score ranges from 17 to 68, with higher scores indicating greater levels of kinesiophobia, meaning stronger fear-avoidance behavior, increased movement-related fear, and greater concern about physical activity causing harm.
Measured: Time Frame: Baseline (pre-intervention), immediately post-intervention at 8 weeks, and follow-up at 8 weeks post-intervention (16 weeks from baseline).
Secondary outcomes (1)
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a widely used and validated tool for assessing subjective pain intensity in both acute and chronic pain conditions. It is simple, sensitive, and responsive to changes in pain, making it suitable for clinical trials and re
Measured: Time Frame: Baseline (pre-intervention), immediately post-intervention at 8 weeks, and follow-up at 8 weeks post-intervention (16 weeks from baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start20 Jan 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mosab ALdabbas, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307859
- Sponsor's protocol ID
- Al Azhar University , Gaza
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 29 Dec 2025
- 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 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pain Neuroscience Education Combined With Lumbar Stabilization Exercises on Disability and Kinesiophobia Among Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07307859
- Acronym / sponsor ID
- Al Azhar University , Gaza
- Conditions
- Chronic Low Back Pain
- Keywords
- pain neuroscience, lumbar stabilization, disability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 29 Dec 2025 (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.
This study will investigate the effect of adding Pain Neuroscience Education (PNE) to a standard lumbar stabilization exercise program on disability and kinesiophobia among patients with chronic low back pain in the Gaza Strip. Participants will be randomly assigned into two groups:
Control group - will receive lumbar stabilization exercises only.
Experimental group - will receive lumbar stabilization exercises in addition to PNE delivered once weekly for 8 sessions.
Both groups will undergo an 8-week intervention, and outcome measures will be collected at baseline, post-intervention (8 weeks), and at a follow-up assessment (16 weeks) to evaluate the persistence of treatment effects. It is expected that the experimental group will show greater improvements in disability and kinesiophobia compared with the control group, indicating that integrating PNE with stabilization exercises may provide enhanced and sustained benefits for patients with chronic low back pain.
Detailed description
This study will explore whether integrating Pain Neuroscience Education (PNE) with a lumbar stabilization exercise program can produce superior clinical outcomes for individuals with chronic low back pain. The intervention will be delivered over eight weeks, with both groups participating in supervised lumbar stabilization sessions. The experimental group will additionally receive weekly PNE sessions designed to improve pain understanding, modify unhelpful beliefs, and reduce fear-avoidance behaviors.
PNE sessions will focus on explaining the neurophysiological mechanisms of chronic pain, emphasizing concepts such as central sensitization, the protective nature of pain, and the role of thoughts, emotions, and movement in pain modulation. The lumbar stabilization exercises will aim to improve trunk control, enhance spinal stability, and promote functional movement patterns.
Participants will be assessed at baseline, after completion of the intervention period, and again at a later follow-up to examine the sustainability of treatment effects. The study is expected to provide evidence on whether combining educational and physical interventions yields greater improvements in disability and kinesiophobia compared with stabilization exercises alone. This information may support future clinical decision-making and contribute to improving physiotherapy services for patients with chronic low back pain in the Gaza Strip.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar Stabilization Exercises | Active comparator | Other: Control Group - Lumbar Stabilization Exercises OnlyStandard Lumbar Stabilization Exercise Program A physiotherapy program focused solely on core and trunk stabilization exercises without additional educational components. |
| Lumbar Stabilization Exercises Plus Pain Neuroscience Education | Experimental | Other: Experimental Group - Lumbar Stabilization Exercises + PNELumbar Stabilization Program Integrated with Weekly Pain Neuroscience Education Sessions A combined intervention including trunk stabilization exercises supported by once-weekly educational sessions addressing pain mechanisms and fear-avoidance beliefs. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults aged 25to 50 years.
- CLBP lasting for more than 12 weeks.
Key exclusion criteria (7 listed)
- History of spinal surgery or fractures.
- Presence of neurological problems.
- Inflammatory conditions, including radiculopathy.
- Pregnancy.
- Body mass index (BMI) ≥ 30.
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 |
|---|---|---|
| Experimental Group - Lumbar Stabilization Exercises + PNEExperimental Group - Lumbar Stabilization Exercises + PNE 1. Lumbar Stabilization Exercises (LSE) Frequency: 3 supervised sessions per week for 8 weeks → Total 24 supervised LSE sessions Session duration: 45-60 minutes Structure each session: Warm-up (5-10 min) Core stabilization program (30-40 min) Cool-down (5-10 min) Progression: Exercises will advance weekly from basic motor control to high-level functional stabilization (details below). Home program: 1 additional short home session weekly (basic LSE). Monitoring: VAS before and after each session. Exercises will be modified if pain rises >2 VAS points. Adherence: Attendance logs 2. Pain Neuroscience Education (PNE) Frequency: Once per week (included within one of the 3 weekly sessions) → Total 8 PNE sessions Duration: 30-40 minutes Format: Small group (≤5) or one-on-one Methods: Metaphors, storytelling, diagrams, role-play, Arabic handouts Learning evaluation: Mini-quizzes, reflective journaling, i | Other | Lumbar Stabilization Exercises Plus Pain Neuroscience Education |
| Control Group - Lumbar Stabilization Exercises OnlyLumbar Stabilization Exercises (LSE) Frequency: 3 supervised sessions per week for 8 weeks → Total 24 supervised LSE sessions Session duration: 45-60 minutes Structure: Identical warm-up, core program, and cool-down as the experimental group. Progression: Identical 8-week exercise progression. Home program: 1 basic LSE home session weekly (same as experimental group). Communication: Therapists will not provide pain education or discuss pain science concepts. Adherence: Attendance logs and SMS reminders identical to the experimental group. | Other | Lumbar Stabilization Exercises |
Primary outcome
Oswestry Disability Index
Time frame: Time Frame: Baseline (pre-intervention), immediately post-intervention at 8 weeks, and follow-up at 8 weeks post-intervention (16 weeks from baseline).
Oswestry Disability Index (ODI) The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category will be followed by six statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5, with the first statement being zero and indicating the least amount of disability. The last statement will score5, showing the most severe 18 disability. The scores for all questions answered are summed and then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability, and
Tampa Scale for Kinesiophobia (TSK)
Time frame: Time Frame: Baseline (pre-intervention), immediately post-intervention at 8 weeks, and follow-up at 8 weeks post-intervention (16 weeks from baseline).
The Tampa Scale for Kinesiophobia (TSK) is a widely used, validated self-report questionnaire designed to assess fear of movement and fear-avoidance beliefs in individuals with musculoskeletal pain, particularly chronic low back pain. The scale measures the degree to which a person fears that movement or physical activity may cause pain or lead to reinjury. The TSK consists of 17 items, each rated on a 4-point Likert scale ranging from: 1. = Strongly disagree 2. = Disagree 3. = Agree 4. = Strongly agree The total score ranges from 17 to 68, with higher scores indicating greater levels of kinesiophobia, meaning stronger fear-avoidance behavior, increased movement-related fear, and greater concern about physical activity causing harm.
1 secondary outcome
Visual Analog Scale (VAS)
Time frame: Time Frame: Baseline (pre-intervention), immediately post-intervention at 8 weeks, and follow-up at 8 weeks post-intervention (16 weeks from baseline).
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 29 Dec 2025.
- 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.
Mosab Aldabbas Last Name or Official Title: Aldabbas First Name: Mosab, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group - Lumbar Stabilization Exercises + PNE in people with Chronic Low Back Pain, run by Al-Azhar University.
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 2 inclusion and 7 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 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Mosab Aldabbas Last Name or Official Title: Aldabbas First Name: Mosab, PhD (00972597451222, mosab.m.aldabbas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (time frame: Time Frame: Baseline (pre-intervention), immediately post-intervention at 8 weeks, and follow-up at 8 weeks post-intervention (16 weeks from baseline).). The study lists 2 primary outcomes in all. 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 29 Dec 2025.