Chronic Low-back PainNCT07772141
Palmitoylethanolamide Modulates Central Sensitisation and Neuroinflammation in Chronic Low Back Pain
A study testing Palmitoylethanolamide in people with Chronic Low-back Pain, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Low back pain (LBP) is a public and occupational health problem that is a major professional, economic and social burden. Up to 84% of the general population will experience an episode of LBP during its life time, and recurrence rates are high. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Palmitoylethanolamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 10 Jun 2027
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With chronic pain (more than 3 months)
- Patients with NRS (4 -7)
- MRI evidence of disc protrusion or prolapse limited to one or two lumbar discs, without extensive multi-level pathology
- Diagnosed clinically with low back pain due to disc disease.
- ASA I and ASA II
Who cannot join
- Neurological disorders
- psychiatric illness
- pregnancy
- prior spinal surgery
- concurrent use of immunomodulatory drugs
- contraindications to TMS.
- Allergy to the drug
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wael Fathy Hassan, M.D contact
Egypt1 site, 1 recruiting
- Recruiting
Beni Suef University Hospital
Banī Suwayf
Mohamed Abdelbadie Ali, Lecturer
Marwa Abd elsalam khames Elgaly, Lecturer
About this study
Official title: Palmitoylethanolamide Modulates Central Sensitisation and Neuroinflammation in Chronic Low Back Pain: A Randomized Controlled Trial With Neurophysiological and Biomarker Correlates
Low back pain (LBP) is a public and occupational health problem that is a major professional, economic and social burden. Up to 84% of the general population will experience an episode of LBP during its life time, and recurrence rates are high. Acute LBP is the second reason for consultations in general medicine, and chronic LBP is the eighth. One in five LBP episodes result in sick leave. LBP represents 30% of sick leaves that are longer than 6 months, and 20% of work accidents. LBP has become the leading cause of exclusion from work before the age of 45, and the third cause of work disabilities in France.
In 2020 globally, LBP affected approximately 619 million people, making it the leading cause of disability worldwide. This number is projected to rise to 843 million by 2050, driven by population growth and aging.
Read the detailed description
Chronic LBP is a heterogenous condition with mixed nociceptive and neuropathic components in many patients. Mechanisms that sustain chronicity include ongoing peripheral nociceptor sensitization, neuroimmune activation (mast cells, microglia), and maladaptive central nervous system plasticity (altered cortical excitability, changes in descending modulatory systems).
Pro-inflammatory cytokines such as TNF-α and IL-1β have been implicated in maintenance of peripheral and central sensitization and the transition from acute to chronic pain. Measuring an inflammatory biomarker (e.g., serum TNF-α) alongside clinical pain and neurophysiological markers can therefore help test an anti-neuroinflammatory treatment hypothesis.
Today's management of chronic LBP includes analgesics (paracetamol), non-steroidal anti-inflammatory drugs, antidepressants, anticonvulsants, opioids, and topical treatments , with oral agents recommended as first-line therapy. Analgesics and non-steroidal anti-inflammatory drugs target the nociceptive component of LBP without affecting neuropathic pain components, while opioids target both nociceptive and (to a lesser degree) neuropathic pain, and antidepressants target only the neuropathic component, although data concerning their efficacy is conflicting.
Analgesics and non-steroidal anti-inflammatory drugs target the nociceptive component of LBP without affecting neuropathic pain components, while opioids target both nociceptive and (to a lesser degree) neuropathic pain, and antidepressants target only the neuropathic component, although data concerning their efficacy is conflicting.
Although relieving neuropathic pain to some extent, classical opioid analgesics suffer from frequent side effects, particularly at the gastrointestinal level that limit their long-term use. An innovative approach in the management of chronic pain diseases is represented by palmitoylethanolamide (PEA), a member of the N-acylethanolamine family, produced by most mammalian cells and which is particularly abundant in brain tissues.
PEA is involved in endogenous protective mechanisms activated by stimulation of inflammatory responses. PEA exerts its effects on cellular targets involved in the generation and maintenance of pain by down-modulating mast cell activation and controlling microglial cell behaviors.
PEA acts through several complementary mechanisms that are relevant to chronic pain: PEA is a ligand of peroxisome proliferator-activated receptor alpha (PPAR-α); activation has anti-inflammatory and analgesic consequences., Mast cell stabilization / Autacoid Local Inflammation Antagonism (ALIA) mechanism: PEA reduces mast cell degranulation and local release of pro-nociceptive mediators, historically described as ALIA. Indirect endocannabinoid-modulating effects: PEA can indirectly modulate the endocannabinoid system, contributing to analgesia without psychotropic effects. Biomarkers can be used to aid diagnosis, clarify disease pathophysiology, classify the extent of a disease, indicate disease prognosis, and predict or monitor the disease over time and in response to interventions.
Central sensitization is defined by the International Association for the Study of Pain (IASP) as an increased responsiveness of nociceptive neurons in the central nervous system to their normal or subthreshold afferent input . Historically, the discovery that injury at peripheral tissues induces hyperexcitability of spinal cord nociceptive neurons has prompted a massive research effort that has consistently confirmed enhanced responsiveness of central nociceptive pathways with different animal models.
One proposed biomarker for assessing CNS pathophysiology in chronic pain is transcranial magnetic stimulation (TMS). TMS uses electromagnetic induction to noninvasively generate an electrical current in the brain.TMS involves a high-current pulse generator that discharges an electrical current of several thousand amperes through an insulated metal stimulating coil for a period of < 1ms, generating a brief and focal magnetic field of approximately 1 to 2 Tesla-].
When the coil is placed on an individual's scalp overlying the primary motor cortex (M1), the magnetic field can induce an intracortical electric current sufficient to depolarize superficial corticospinal neurons and activate a target muscle leading to a measurable electromyographic responseThe neurotransmitters involved in various TMS-evoked measurements have been well characterized thus making TMS a putative biomarker for the study of chronic pain.
Mechanistic link between TNF-α and TMS measures:Neuroinflammation, characterized by elevated levels of proinflammatory cytokines such as tumor necrosis factor-alpha (TNF-α), can profoundly influence cortical excitability. TNF-α modulates synaptic transmission by enhancing AMPA receptor trafficking to the postsynaptic membrane and reducing GABA_A receptor surface expression, leading to an imbalance between excitatory and inhibitory neurotransmission.
This cytokine-driven shift toward hyperexcitability alters the functional state of intracortical circuits. Transcranial magnetic stimulation (TMS) provides a noninvasive means to quantify these changes: short-interval intracortical inhibition (SICI) reflects GABA_A-mediated inhibitory tone, while intracortical facilitation (ICF) reflects glutamatergic excitatory activity.
- Conditions
- Chronic Low-back Pain
- Being tested
- Palmitoylethanolamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalmitoylethanolamideDrug
Also called traditional treatment
to evaluate the effect of PEA and traditional treatment versus traditional treatment alone for the patiens with chronic low back pain on pain intensity, disability and patient satisfaction at baseline, 3 months, and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Micronized Palmitoylethanolamide Group | Active comparator | About 53 patients suffering from low back pain will receive Micronized Palmitoylethanolamide 600 mg tablets orally twice daily with the traditional treatment (NSAIDs, muscle relaxant and gabapentin): and physiotherapy for 6 months. Receives: Drug: Palmitoylethanolamide |
| Control group | Active comparator | About 53 patients suffering from low back pain will receive Traditional treatment (NSAIDs, Muscle relaxant, gabapentin) and physiotherapy. Receives: Drug: Palmitoylethanolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of Chronic Low Back Pain
Number of Participants With Treatment by adjunctive Palmitoylethanolamide Assessed by reducing pain intensity from baseline to 3 months and 6 months following treatment initiation, as measured by the Numeric Rating Scale (NRS). NRS ranges from 0 = no pain to 10 = worst imaginable pain.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Jan 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion10 Jun 2027 (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 Beni-Suef 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Essam Nasrallah, Beni-Suef University
- Investigators
- Hatem Elmoutaz Mahmoud, M.D, Study chair, Professor of Anaesthesiology,Surgical intensive care and pain management,Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772141
- Sponsor's protocol ID
- Chronic Low Back Pain
- Status last verified
- Jan 2026
- First submitted
- 12 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palmitoylethanolamide Modulates Central Sensitisation and Neuroinflammation in Chronic Low Back Pain: A Randomized Controlled Trial With Neurophysiological and Biomarker Correlates
- ClinicalTrials.gov ID
- NCT07772141
- Acronym / sponsor ID
- Chronic Low Back Pain
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 10 Jun 2027 (estimated)
- First posted
- 19 Aug 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.
Low back pain (LBP) is a public and occupational health problem that is a major professional, economic and social burden. Up to 84% of the general population will experience an episode of LBP during its life time, and recurrence rates are high. Acute LBP is the second reason for consultations in general medicine, and chronic LBP is the eighth. One in five LBP episodes result in sick leave. LBP represents 30% of sick leaves that are longer than 6 months, and 20% of work accidents. LBP has become the leading cause of exclusion from work before the age of 45, and the third cause of work disabilities in France.
In 2020 globally, LBP affected approximately 619 million people, making it the leading cause of disability worldwide. This number is projected to rise to 843 million by 2050, driven by population growth and aging.
Detailed description
Chronic LBP is a heterogenous condition with mixed nociceptive and neuropathic components in many patients. Mechanisms that sustain chronicity include ongoing peripheral nociceptor sensitization, neuroimmune activation (mast cells, microglia), and maladaptive central nervous system plasticity (altered cortical excitability, changes in descending modulatory systems).
Pro-inflammatory cytokines such as TNF-α and IL-1β have been implicated in maintenance of peripheral and central sensitization and the transition from acute to chronic pain. Measuring an inflammatory biomarker (e.g., serum TNF-α) alongside clinical pain and neurophysiological markers can therefore help test an anti-neuroinflammatory treatment hypothesis.
Today's management of chronic LBP includes analgesics (paracetamol), non-steroidal anti-inflammatory drugs, antidepressants, anticonvulsants, opioids, and topical treatments , with oral agents recommended as first-line therapy. Analgesics and non-steroidal anti-inflammatory drugs target the nociceptive component of LBP without affecting neuropathic pain components, while opioids target both nociceptive and (to a lesser degree) neuropathic pain, and antidepressants target only the neuropathic component, although data concerning their efficacy is conflicting.
Analgesics and non-steroidal anti-inflammatory drugs target the nociceptive component of LBP without affecting neuropathic pain components, while opioids target both nociceptive and (to a lesser degree) neuropathic pain, and antidepressants target only the neuropathic component, although data concerning their efficacy is conflicting.
Although relieving neuropathic pain to some extent, classical opioid analgesics suffer from frequent side effects, particularly at the gastrointestinal level that limit their long-term use. An innovative approach in the management of chronic pain diseases is represented by palmitoylethanolamide (PEA), a member of the N-acylethanolamine family, produced by most mammalian cells and which is particularly abundant in brain tissues.
PEA is involved in endogenous protective mechanisms activated by stimulation of inflammatory responses. PEA exerts its effects on cellular targets involved in the generation and maintenance of pain by down-modulating mast cell activation and controlling microglial cell behaviors.
PEA acts through several complementary mechanisms that are relevant to chronic pain: PEA is a ligand of peroxisome proliferator-activated receptor alpha (PPAR-α); activation has anti-inflammatory and analgesic consequences., Mast cell stabilization / Autacoid Local Inflammation Antagonism (ALIA) mechanism: PEA reduces mast cell degranulation and local release of pro-nociceptive mediators, historically described as ALIA. Indirect endocannabinoid-modulating effects: PEA can indirectly modulate the endocannabinoid system, contributing to analgesia without psychotropic effects. Biomarkers can be used to aid diagnosis, clarify disease pathophysiology, classify the extent of a disease, indicate disease prognosis, and predict or monitor the disease over time and in response to interventions.
Central sensitization is defined by the International Association for the Study of Pain (IASP) as an increased responsiveness of nociceptive neurons in the central nervous system to their normal or subthreshold afferent input . Historically, the discovery that injury at peripheral tissues induces hyperexcitability of spinal cord nociceptive neurons has prompted a massive research effort that has consistently confirmed enhanced responsiveness of central nociceptive pathways with different animal models.
One proposed biomarker for assessing CNS pathophysiology in chronic pain is transcranial magnetic stimulation (TMS). TMS uses electromagnetic induction to noninvasively generate an electrical current in the brain.TMS involves a high-current pulse generator that discharges an electrical current of several thousand amperes through an insulated metal stimulating coil for a period of < 1ms, generating a brief and focal magnetic field of approximately 1 to 2 Tesla-].
When the coil is placed on an individual's scalp overlying the primary motor cortex (M1), the magnetic field can induce an intracortical electric current sufficient to depolarize superficial corticospinal neurons and activate a target muscle leading to a measurable electromyographic responseThe neurotransmitters involved in various TMS-evoked measurements have been well characterized thus making TMS a putative biomarker for the study of chronic pain.
Mechanistic link between TNF-α and TMS measures:Neuroinflammation, characterized by elevated levels of proinflammatory cytokines such as tumor necrosis factor-alpha (TNF-α), can profoundly influence cortical excitability. TNF-α modulates synaptic transmission by enhancing AMPA receptor trafficking to the postsynaptic membrane and reducing GABA_A receptor surface expression, leading to an imbalance between excitatory and inhibitory neurotransmission.
This cytokine-driven shift toward hyperexcitability alters the functional state of intracortical circuits. Transcranial magnetic stimulation (TMS) provides a noninvasive means to quantify these changes: short-interval intracortical inhibition (SICI) reflects GABA_A-mediated inhibitory tone, while intracortical facilitation (ICF) reflects glutamatergic excitatory activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micronized Palmitoylethanolamide Group | Active comparator | Drug: PalmitoylethanolamideAbout 53 patients suffering from low back pain will receive Micronized Palmitoylethanolamide 600 mg tablets orally twice daily with the traditional treatment (NSAIDs, muscle relaxant and gabapentin): and physiotherapy for 6 months. |
| Control group | Active comparator | Drug: PalmitoylethanolamideAbout 53 patients suffering from low back pain will receive Traditional treatment (NSAIDs, Muscle relaxant, gabapentin) and physiotherapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- With chronic pain (more than 3 months)
- Patients with NRS (4 -7)
- MRI evidence of disc protrusion or prolapse limited to one or two lumbar discs, without extensive multi-level pathology
- Diagnosed clinically with low back pain due to disc disease.
- ASA I and ASA II
Key exclusion criteria (7 listed)
- Neurological disorders
- psychiatric illness
- pregnancy
- prior spinal surgery
- concurrent use of immunomodulatory drugs
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 |
|---|---|---|
| PalmitoylethanolamideAlso: traditional treatmentto evaluate the effect of PEA and traditional treatment versus traditional treatment alone for the patiens with chronic low back pain on pain intensity, disability and patient satisfaction at baseline, 3 months, and 6 months. | Drug | Control group, Micronized Palmitoylethanolamide Group |
Primary outcome
Treatment of Chronic Low Back Pain
Time frame: 6 Months
Number of Participants With Treatment by adjunctive Palmitoylethanolamide Assessed by reducing pain intensity from baseline to 3 months and 6 months following treatment initiation, as measured by the Numeric Rating Scale (NRS). NRS ranges from 0 = no pain to 10 = worst imaginable pain.
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 19 Aug 2026.
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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.
Wael Fathy Hassan, M.D contact
Hatem Elmoutaz Mahmoud, M.D study chair
Professor of Anaesthesiology,Surgical intensive care and pain management,Faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palmitoylethanolamide in people with Chronic Low-back Pain, run by Beni-Suef University at 1 site in Egypt.
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 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: looking for participants now, as of the sponsor's last update on 19 Aug 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 Egypt. 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 Hager Essam Nasrallah (+201149106597, hagernasrallah778@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of Chronic Low Back Pain (time frame: 6 Months). 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 19 Aug 2026.