Pentoxifylline and Lumbar Radiculopathy

April 18, 2023 updated by: Dr Joseph Maarrawi, St Joseph University, Beirut, Lebanon

Prospective Controlled Crossover Study of the Role of Pentoxifylline in the Management of Lumbar Radiculopathy

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Ibuprofen
Drug: Ibuprofen
patient will receive for 15 days: Ibuprofen 600 mg bid; pregabalin 75 mg bid; paracetamol 1 g tid
Other Names:
  • Paracetamol
  • pregabalin
Experimental: Pentoxifylline
Pentoxifylline oral tablets
Drug: Pentoxifylline Oral Tablet
patient will receive for 15 days: Ibuprofen 600 mg bid; pregabalin 75 mg bid; paracetamol 1 g tid; pentoxifylline 400 mg bid
Other Names:
  • Paracetamol
  • Ibuprofen
  • pregabalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical rating scale (NRS)
Time Frame: At day 15 (and Day 30)
Pain assessment by NRS
At day 15 (and Day 30)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient global impression of improvement scale
Time Frame: day 15 and 30
pain improvement scale from 1 to 7
day 15 and 30
Side effects
Time Frame: Day 15 and 30
Reporting side effects by patient
Day 15 and 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St Joseph University, Beirut, Lebanon

Investigators

  • Principal Investigator: Joseph Maarrawi, MD, PhD, Hotel Dieu de France Hospital - Beirut, Lebanon, 16 6830

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 18, 2017

First Submitted That Met QC Criteria

February 18, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pento-LR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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