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RECRUITING Not applicable ClinicalTrials.gov

Palmitoylethanolamide Modulates Central Sensitisation and Neuroinflammation in Chronic Low Back Pain

Sponsor: Beni-Suef University • ClinicalTrials.gov ID: NCT07772141

Registry updated: 2026-08-19
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Description

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.

Interventions

  • Palmitoylethanolamide (Drug)
    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.

Eligibility criteria

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

Conditions

Chronic Low-back Pain

Locations

  • Beni Suef University Hospital — Banī Suwayf, Egypt
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record