Pentoxifylline and Lumbar Radiculopathy

NCT03060434 | Active Not Recruiting Phase 4

• 1 other identifier: Pento-LR
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this prospective controlled crossover study is to evaluate the efficacy and safety of pentoxifylline per os (800 mg daily) in the management of lumbar radiculopathy

Conditions

Lumbar Radiculopathy; Lumbar Disc Herniation; Lumbar Disc Disease

Keywords

pentoxifylline; Disc hernia; sciatica; lumbar radiculopathy

Outcome Measures

Primary Outcomes (1)

• Numerical rating scale (NRS)

  Pain assessment by NRS

  At day 15 (and Day 30)

Secondary Outcomes (2)

• Patient global impression of improvement scale

  day 15 and 30

• Side effects

  Day 15 and 30

Study Arms (2)

Control

ACTIVE COMPARATOR

Ibuprofen

Drug: Ibuprofen

Pentoxifylline

EXPERIMENTAL

Pentoxifylline oral tablets

Drug: Pentoxifylline Oral Tablet

Interventions

Pentoxifylline Oral Tablet DRUG

patient will receive for 15 days: Ibuprofen 600 mg bid; pregabalin 75 mg bid; paracetamol 1 g tid; pentoxifylline 400 mg bid

Also known as: Ibuprofen, Paracetamol, pregabalin

Pentoxifylline

Ibuprofen DRUG

patient will receive for 15 days: Ibuprofen 600 mg bid; pregabalin 75 mg bid; paracetamol 1 g tid

Also known as: Paracetamol, pregabalin

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral lumbar radiculopathy
• Disc hernia confirming the diagnosis with radio-clinical concordance

You may not qualify if:

• Radicular deficit needing surgery
• Cauda equine syndrome
• Absence of radio-clinical concordance on MRI
• Contraindication for anti-inflammatory (Hypertension, renal insufficiency, gastric ulcer …)
• Previous intolerance to pentoxifylline, and/or to pregabalin and/or paracetamol
• Pregnancy
• Follow-up not possible
• Hepatic dysfunction
• History of drug abuse
• Current use of tramadol, codeine and/or morphine and its derivative
• Antidepressant use

Sponsors & Collaborators

• St Joseph University, Beirut, Lebanon: lead

Study Sites (1)

Hotel Dieu de France Hospital

Beirut, 16 6830, Lebanon

Location

MeSH Terms

Conditions

Radiculopathy; Intervertebral Disc Displacement; Intervertebral disc disease; Sciatica

Interventions

Pentoxifylline; Ibuprofen; Acetaminophen; Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Joseph Maarrawi, MD, PhD

  Hotel Dieu de France Hospital - Beirut, Lebanon, 16 6830

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The assessor and the investigator are unaware of the sequence of the 15 days treatment with pentoxifylline
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor : Researcher - Pain Specialist - Neurosurgeon

Model Details: Each patient will receive for 1 month: Ibuprofen 600 mg bid; Paracetamol 1g tid if needed; pregabalin 75 mg bid pentoxifylline 400 mg bid will be added for either the first or second 15 days (randomization)

Study Record Dates

• First Submitted: February 18, 2017
• First Posted: February 23, 2017
• Study Start: June 1, 2018
• Primary Completion: December 1, 2022
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)