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Palmitoylethanolamide Modulates Central Sensitisation and Neuroinflammation in Chronic Low Back Pain

17 agosto 2026 aggiornato da: Hager Essam Nasrallah, Beni-Suef University

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.

Panoramica dello studio

Stato

Reclutamento

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

106

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Wael Fathy Hassan, M.D

Luoghi di studio

      • Banī Suwayf, Egitto
        • Reclutamento
        • Beni Suef University Hospital
        • Contatto:
          • Mohamed Abdelbadie Ali, Lecturer
        • Contatto:
          • Marwa Abd elsalam khames Elgaly, Lecturer

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Neurological disorders
  • psychiatric illness
  • pregnancy
  • prior spinal surgery
  • concurrent use of immunomodulatory drugs
  • contraindications to TMS.
  • Allergy to the drug

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Micronized Palmitoylethanolamide Group
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.
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.
Altri nomi:
  • traditional treatment
Comparatore attivo: Control group
About 53 patients suffering from low back pain will receive Traditional treatment (NSAIDs, Muscle relaxant, gabapentin) and physiotherapy.
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.
Altri nomi:
  • traditional treatment

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Treatment of Chronic Low Back Pain
Lasso di tempo: 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.
6 Months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Cattedra di studio: Hatem Elmoutaz Mahmoud, M.D, Professor of Anaesthesiology,Surgical intensive care and pain management,Faculty of medicine

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

10 giugno 2027

Date di iscrizione allo studio

Primo inviato

12 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 agosto 2026

Primo Inserito (Effettivo)

19 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 agosto 2026

Ultimo verificato

1 gennaio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Chronic Low Back Pain

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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