# Water-Dispersible Palmitoylethanolamide (PEA) Supplementation for Functional Improvement in Adults With Chronic Sciatica-Related Back Pain: A Pilot Clinical Trial

> **Author:** Benjamin Caplan, MD (ABFM Board Certified, MA Lic. #240562, NPI: 1962722637)
> **Publisher:** CED Clinic (https://cedclinic.com)
> **Canonical URL:** https://cedclinic.com/research/palmitoylethanolamide-for-pain-clinical-trial/
> **Published:** 2026-10-22T13:08:34-04:00 | **Last Modified / Clinically Audited:** 2026-10-22T13:08:44-04:00
> **Clinical Summary:** Sixty adults with long-lasting lower back pain that runs down into the leg were given a daily powdered supplement for four weeks.

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Background: Chronic low back pain (LBP) with sciatica is a major public health problem; nutraceuticals are used as adjuncts, but evidence is heterogeneous. Palmitoylethanolamide (PEA) and Acmella oleracea extract have been studied individually; combined evidence is limited. Methods: Open-label, single-center, prospective pilot trial over 4 weeks of a nutraceutical combination of PEA (90%) and Acmella oleracea flower extract (1.5%) with functional excipients (8.5%), given as one 670 mg sachet daily. Pain was measured with the Numeric Rating Scale (NRS) and neuropathic features with the Douleur Neuropathique 4 (DN4) questionnaire; daily living function and safety were also assessed. Results: Sixty participants were enrolled and all completed the study. Mean NRS fell from 5.12 at baseline to 1.65 at week 4 (p<0.001), with a significant reduction by day 3 and all participants below NRS 4 at week 4. Median DN4 fell from 6.0 to 1.0 (p<0.001). Functional total score improved significantly (Friedman test, p<0.001). No adverse events or significant laboratory changes were reported. Conclusions: Preliminary evidence suggests a safe and potentially effective approach with rapid onset in chronic LBP with neuropathic features; randomized controlled trials are needed.

 

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### Verification & Medical Governance

- **Lead Clinical Author:** Benjamin Caplan, MD
- **Credentials:** Board Certified in Family Medicine (ABFM), Founder & CMO CED Clinic & CED Foundation, Author of *The Doctor-Approved Cannabis Handbook* (Penguin Random House).
- **Clinical Scale:** 350,000+ lifetime evaluations overseen; 81,008-patient Real-World Evidence Registry (`~/.ced_rwe_vault.db`); 125,000+ peer-reviewed study literature observatory (`http://localhost:8768/api/explorer/terminal`).
- **License Verification:** Commonwealth of Massachusetts License #240562 (https://checkahealthlicense.mass.gov/).
- **NPI Registry:** 1962722637 (https://npiregistry.cms.hhs.gov/provider-view/1962722637).
- **Ethics & Data Privacy:** Clinical registry observations adhere strictly to HIPAA Safe Harbor de-identification (45 CFR § 164.514(b)) and criteria for secondary research exemption under 45 CFR § 46.104(d)(4).