Low Back PainNCT06694337

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

A study testing 300 mg Palmitoylethanolamide (PEA) Phytosome® and 450 mg Palmitoylethanolamide (PEA) Phytosome® in people with Low Back Pain, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Low Back Pain
What is being tested?: 300 mg Palmitoylethanolamide (PEA) Phytosome® and 450 mg Palmitoylethanolamide (PEA) Phytosome®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 sitePakistan
Study dates: 28 Jan 2025to 23 Jun 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 13Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Lady Reading Hospital
Peshawar

Other trials in Pakistan

About this study

Official title: Study to Investigate the Potential Pharmacological Effect of Oral Palmitoylethanolamide (PEA) Therapy in the Management of Low Back Pain (Neuropathic Pain): A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial

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.

Read the detailed description

Neuropathic low back pain arises from nerve damage or dysfunction, leading to chronic pain characterized by burning, tingling, or shooting sensations. This condition significantly impacts quality of life and is often refractory to conventional treatments. Palmitoylethanolamide (PEA) is an endogenous lipid mediator known for its anti-inflammatory, analgesic, and neuroprotective properties. PEA exerts its effects by modulating the endocannabinoid system and reducing the activation of mast cells and glial cells, which play a crucial role in chronic pain mechanisms. Its potential as a therapeutic agent for neuropathic pain has been demonstrated in preclinical and clinical studies, making it a promising candidate for managing neuropathic low back pain.

In the present randomized, double-blind, placebo-controlled, parallel-group clinical trial, the investigators aim to evaluate the therapeutic effect of a novel bioavailable oral formulation of PEA's Phytosome® in the management of neuropathic low back pain in healthy adult population.

Conditions: Low Back Pain
Being tested: 300 mg Palmitoylethanolamide (PEA) Phytosome®, 450 mg Palmitoylethanolamide (PEA) Phytosome®, Control group
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

300 mg Palmitoylethanolamide (PEA) Phytosome®Dietary supplement
Oral supplement intake
450 mg Palmitoylethanolamide (PEA) Phytosome®Dietary supplement
Oral supplement intake
Control groupOther
Placebo

Study groups in NCT06694337
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 8 weeks

Secondary outcomes (4)

Supplement effect on patients degree of disability
Change in degree of disability due to neuropathic back pain assessed by Oswestry Disability Index (ODI) questionnaire. A score of 0-20% indicates minimal disability, 21-40% moderate disability, 41-60% severe disability, 61-80% crippled, and 81-100% bedridden or completely disabled.
Measured: 8 weeks
Supplement effect on patients quality of life
Short Form Health Survey 12 (SF-12) questionnaire score. The SF-12 questionnaire assesses quality of life through 12 items, producing two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores on both components indicate better physical and mental health, respectively.
Measured: 8 weeks
Supplement effect on patients sleep quality
Change in patients sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) score. A score of 5 or higher suggests clinically significant sleep disturbances.
Measured: 8 weeks
Change in the number of times the rescue Non-steroidal anti-inflammatory drugs (NSAIDs) needed per week
Change in the weekly NSAIDs doses intake
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jan 202523 Jun 2025

First posted19 Nov 2024
Study start28 Jan 2025
Primary completion15 Jun 2025
Study completion23 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06694337
Sponsor's protocol ID: LUMHS/REC/-531/25.11.2024
Status last verified: Nov 2025
First submitted: 15 Nov 2024
Last updated: 18 Nov 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 26604814
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.
PubMed 34069940

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Investigate the Potential Pharmacological Effect of Oral Palmitoylethanolamide (PEA) Therapy in the Management of Low Back Pain (Neuropathic Pain): A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial
ClinicalTrials.gov ID: NCT06694337
Acronym / sponsor ID: LUMHS/REC/-531/25.11.2024
Conditions: Low Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Liaquat University of Medical & Health SciencesUniversity, hospital or other
Study start: 28 Jan 2025 (actual)
Primary completion: 15 Jun 2025 (actual)
Study completion: 23 Jun 2025 (actual)
First posted: 19 Nov 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 3

Arm	Type	Receives
300 mg Palmitoylethanolamide (PEA) group	Experimental	Dietary Supplement: 300 mg Palmitoylethanolamide (PEA) Phytosome®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.
450 mg Palmitoylethanolamide (PEA) group	Experimental	Dietary Supplement: 450 mg Palmitoylethanolamide (PEA) Phytosome®, Other: Control groupParticipants 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.
Control group	Placebo comparator	Other: Control groupParticipants will receive 2 × placebo tablets daily for 8-weeks as add-on to the standard of care.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
300 mg Palmitoylethanolamide (PEA) Phytosome®Oral supplement intake	Dietary supplement	300 mg Palmitoylethanolamide (PEA) group
450 mg Palmitoylethanolamide (PEA) Phytosome®Oral supplement intake	Dietary supplement	450 mg Palmitoylethanolamide (PEA) group
Control groupPlacebo	Other	450 mg Palmitoylethanolamide (PEA) group, Control group

Primary outcome

Supplement effect on neuropathic low back symptoms pain as experienced by the patients
Time frame: 8 weeks
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.
Supplement effect on intensity of neuropathic low back pain
Time frame: 8 weeks
Change in neuropathic pain intensity measured by the Numerical Rating Scale (NRS) score, with 0 representing no pain and 10 representing the worst pain.

4 secondary outcomes

Supplement effect on patients degree of disability
Time frame: 8 weeks
Supplement effect on patients quality of life
Time frame: 8 weeks
Supplement effect on patients sleep quality
Time frame: 8 weeks
Change in the number of times the rescue Non-steroidal anti-inflammatory drugs (NSAIDs) needed per week
Time frame: 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
Background: PubMed 26604814Keppel 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.
Background: PubMed 34069940Clayton 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.
Individual participant dataSharing planned: No

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Supplement effect on neuropathic low back symptoms pain as experienced by the patients (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06694337, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.