Pentoxifylline and Lumbar Radiculopathy

Overview

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

Full Title of Study: “Prospective Controlled Crossover Study of the Role of Pentoxifylline in the Management of Lumbar Radiculopathy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 1, 2022

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.

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Control
    • Ibuprofen
  • Experimental: Pentoxifylline
    • Pentoxifylline oral tablets

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • St Joseph University, Beirut, Lebanon
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr Joseph Maarrawi, Associate Professor : Researcher – Pain Specialist – Neurosurgeon – St Joseph University, Beirut, Lebanon
  • Overall Official(s)
    • Joseph Maarrawi, MD, PhD, Principal Investigator, Hotel Dieu de France Hospital – Beirut, Lebanon, 16 6830

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