Palmitoylethanolamide Modulates Central Sensitisation and Neuroinflammation in Chronic Low Back Pain

Condition(s) studied

Investigational drug(s) / intervention(s)

Palmitoylethanolamide: 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 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. 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.

Eligibility

Primary outcome measure(s)

• Treatment of Chronic Low Back Pain — 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.

Trial sites (1)

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