NCT07772141

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Jan 2026Jun 2027

Study Start

First participant enrolled

January 1, 2026

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2027

Last Updated

August 19, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

August 12, 2026

Last Update Submit

August 17, 2026

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (1)

  • Treatment of Chronic Low Back Pain

    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.

    6 Months

Study Arms (2)

Micronized Palmitoylethanolamide Group

ACTIVE COMPARATOR

About 53 patients suffering from low back pain will receive Micronized Palmitoylethanolamide 600 mg tablets orally twice daily with the traditional treatment (NSAIDs, muscle relaxant and gabapentin): and physiotherapy for 6 months.

Drug: Palmitoylethanolamide

Control group

ACTIVE COMPARATOR

About 53 patients suffering from low back pain will receive Traditional treatment (NSAIDs, Muscle relaxant, gabapentin) and physiotherapy.

Drug: Palmitoylethanolamide

Interventions

PalmitoylethanolamideDRUG

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.

Also known as: traditional treatment
Control groupMicronized Palmitoylethanolamide Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Neurological disorders
  • psychiatric illness
  • pregnancy
  • prior spinal surgery
  • concurrent use of immunomodulatory drugs
  • contraindications to TMS.
  • Allergy to the drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni Suef University Hospital

Banī Suwayf, Egypt

RECRUITING

MeSH Terms

Interventions

palmidrol

Study Officials

  • Hatem Elmoutaz Mahmoud, M.D

    Professor of Anaesthesiology,Surgical intensive care and pain management,Faculty of medicine

    STUDY CHAIR

Central Study Contacts

Hager Essam Nasrallah

CONTACT

+201149106597hagernasrallah778@gmail.com

Wael Fathy Hassan, M.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist at Anaesthesiology, Surgical intensive care unit and pain management

Study Record Dates

First Submitted

August 12, 2026

First Posted

August 19, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 10, 2027

Last Updated

August 19, 2026

Record last verified: 2026-01

Locations

EG(1)