Palmitoylethanolamide for Central Sensitisation and Neuroinflammation in Chronic Low Back Pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests whether palmitoylethanolamide can modulate central sensitisation and neuroinflammation in adults with chronic lumbar disc–related pain. Participants have chronic low back pain for more than 3 months, moderate pain (NRS 4–7), and MRI-confirmed disc protrusion limited to one or two lumbar levels. The trial focuses on anti-neuroinflammatory effects and will compare pain-related and neurophysiological outcomes, alongside standard care. Eligibility includes ASA I–II status and exclusion of neurological or psychiatric comorbidities, pregnancy, prior spinal surgery, and certain medications. The investigation is conducted at Beni-Suef University Hospital under the lead sponsor Beni-Suef University.

Why it matters

Who can join: the full rules

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

Where it's running

• Beni Suef University Hospital
  Banī Suwayf, Egypt Recruiting

Study contacts

• Study coordinator: Hager Essam Nasrallah
• Email: hagernasrallah778@gmail.com
• Phone: +201149106597

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.