Study to Investigate the Potential Pharmacological Effect of Oral Palmitoylethanolamide (PEA) Therapy in the Management of Low Back Pain (Neuropathic Pain)

NCT06694337 | Completed DMC

• 1 other identifier: LUMHS/REC/-531/25.11.2024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to evaluate the potential therapeutic effects of oral supplemental Palmitoylethanolamide (PEA) Phytosome® in managing neuropathic low back pain. The study will involve adult participants diagnosed with neuropathic pain according to established criteria. Eligible participants will be randomized into three groups to receive either PEA Phytosome® supplementation as two different doses or a placebo for a specified period. Data collection will include demographic information, baseline pain intensity, quality of life assessments, and functional outcomes. The primary endpoint will be the reduction in pain intensity, while secondary endpoints will include improvements in quality of life and functional capacity. Safety and tolerability of the supplement will also be assessed. This trial seeks to provide robust clinical evidence of the potential pharmacological effect of PEA's Phytosome® as a potential adjunctive treatment for neuropathic low back pain.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Supplement effect on neuropathic low back symptoms pain as experienced by the patients

  Change in The Douleur Neuropathique 4 (DN4) questionnaire score, a 10-item, clinician-administered tool used to identify neuropathic pain. A score of 4 or more out of 10 is the cut-off for defining the presence of neuropathic pain.

  8 weeks

• Supplement effect on intensity of neuropathic low back pain

  Change in neuropathic pain intensity measured by the Numerical Rating Scale (NRS) score, with 0 representing no pain and 10 representing the worst pain.

  8 weeks

Secondary Outcomes (4)

• Supplement effect on patients degree of disability

  8 weeks

• Supplement effect on patients quality of life

  8 weeks

• Supplement effect on patients sleep quality

  8 weeks

• Change in the number of times the rescue Non-steroidal anti-inflammatory drugs (NSAIDs) needed per week

  8 weeks

Study Arms (3)

300 mg Palmitoylethanolamide (PEA) group

EXPERIMENTAL

Participants will receive 2 × 300 mg oral PEA Phytosome® tablets daily for one week, and a single tablet from week-7 to week-8, as add-on to the standard of care.

Dietary Supplement: 300 mg Palmitoylethanolamide (PEA) Phytosome®

450 mg Palmitoylethanolamide (PEA) group

EXPERIMENTAL

Participants will receive 1 × 450 mg oral PEA Phytosome® tablet, and 1 placebo tablet daily for 8-weeks as add-on to the standard of care.

Dietary Supplement: 450 mg Palmitoylethanolamide (PEA) Phytosome®; Other: Control group

Control group

PLACEBO COMPARATOR

Participants will receive 2 × placebo tablets daily for 8-weeks as add-on to the standard of care.

Other: Control group

Interventions

300 mg Palmitoylethanolamide (PEA) Phytosome® DIETARY_SUPPLEMENT

Oral supplement intake

300 mg Palmitoylethanolamide (PEA) group

450 mg Palmitoylethanolamide (PEA) Phytosome® DIETARY_SUPPLEMENT

Oral supplement intake

450 mg Palmitoylethanolamide (PEA) group

Control group OTHER

Placebo

450 mg Palmitoylethanolamide (PEA) group; Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults, both Male or female aged ≥ 18 years and ≤ 80 years;
• Diagnosed with neuropathic lower back pain for at least 3 months, as confirmed by clinical evaluation and DN4 (neuropathic pain 4 questions) screening questionnaire with score ≥4.
• Pain intensity score ≥ 5 measured by NRS (Numerical Rating Scale) score, over the past week.
• Willingness to adhere to study protocol, including visits, assessments, and self-reporting of symptoms.
• Ability to provide informed consent and comply with study requirements.

You may not qualify if:

• Known intolerance or allergy to any component of the tested nutraceuticals
• Presence of acute systemic disease
• Presence of significant organic pathology
• Current or past history of alcohol or drug abuse
• History of malignancy within the past 5 years
• Any significant concomitant disease or clinical condition that could compromise participant safety or interfere with study completion
• Women of childbearing potential not using reliable contraceptive methods
• Pregnancy or breastfeeding
• Severe psychiatric disorders (e.g., major depression, schizophrenia) that could affect pain perception or adherence.
• Inability to adhere to the study requirements due to lifestyle, transportation, or cognitive impairment.
• Use of other cannabinoid-based therapies, investigational drugs, or concurrent participation in another clinical trial.
• Dependence on opioid analgesics or recent opioid use that may interfere with pain assessment.
• Current use of other supplements with potential anti-inflammatory or analgesic effects, including Omega-3 Fatty Acids, Turmeric/Curcumin, Glucosamine and Chondroitin, Boswellia Serrata, Methylsulfonylmethane.

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead

Study Sites (1)

Lady Reading Hospital

Peshawar, Pakistan

Location

Related Publications (2)

• Keppel Hesselink JM, Kopsky DJ. Palmitoylethanolamide, a neutraceutical, in nerve compression syndromes: efficacy and safety in sciatic pain and carpal tunnel syndrome. J Pain Res. 2015 Oct 23;8:729-34. doi: 10.2147/JPR.S93106. eCollection 2015.

  PMID: 26604814 BACKGROUND

• Clayton P, Hill M, Bogoda N, Subah S, Venkatesh R. Palmitoylethanolamide: A Natural Compound for Health Management. Int J Mol Sci. 2021 May 18;22(10):5305. doi: 10.3390/ijms22105305.

  PMID: 34069940 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

palmidrol; Control Groups

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: January 28, 2025
• Primary Completion: June 15, 2025
• Study Completion: June 23, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)