Pentoxifylline and Lumbar Radiculopathy

Phase 4

Active, not recruiting

• Conditions: Lumbar Radiculopathy; Lumbar Disc Disease; Lumbar Disc Herniation
• Interventions: Drug: Pentoxifylline Oral Tablet; Drug: Ibuprofen

• Registration Number: NCT03060434
• Lead Sponsor: St Joseph University, Beirut, Lebanon

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

Detailed Description

Patients with lumbar radiculopathy, are recruited from senior author clinic. After verification of inclusion and exclusion criteria, patients consenting to enter the study are given 2 sequences (order randomly assigned) of treatment: Ibuprofen 600 mg bid, with paracetamol 1000 mg tid, pregabalin 75 mg bid for 15 days with pentoxifylline and 15 days without it. Basic clinical and demographical data are noted. Lumbar MRI results are also noted. Clinical evaluation of the patient is performed and included: clinical examination (including motor exam of lower limbs); pain is assessed according to Numerical rating Scale (NRS), and relative percentage of global improvement.

Study Timeline

• Study First Submitted: 2017-02-18
• Study First Submitted QC: 2017-02-18
• Study First Posted: 2017-02-23
• Study Start: 2018-06-01
• Primary Completion: 2022-12-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-18
• Last Update Posted: 2025-05-21
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pentoxifylline	Pentoxifylline Oral Tablet	Pentoxifylline oral tablets
Control	Ibuprofen	Ibuprofen

Primary Outcome Measures

Name	Time	Method
Numerical rating scale (NRS)	At day 15 (and Day 30)	Pain assessment by NRS

Secondary Outcome Measures

Name	Time	Method
Patient global impression of improvement scale	day 15 and 30	pain improvement scale from 1 to 7
Side effects	Day 15 and 30	Reporting side effects by patient

Trial Locations

Locations (1)

Hotel Dieu de France Hospital; 🇱🇧 Beirut, Lebanon