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OpenTrials
Active, Not Recruiting

NCT Number: NCT03060434

Pentoxifylline and 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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lumbar Radiculopathy Bone Diseases Hernia Intervertebral Disc Displacement Intervertebral disc disease Lumbar Disc Disease Lumbar Disc Herniation Mononeuropathies Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Sciatic Neuropathy Sciatica Signs and Symptoms Spinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hotel Dieu de France Hospital

Beirut, 16 6830, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Ibuprofen, Paracetamol, pregabalin

Ibuprofen

Drug

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

Other names: Paracetamol, pregabalin

Primary outcomes

  1. Numerical rating scale (NRS)

    Time frame: At day 15 (and Day 30)

    Pain assessment by NRS

Secondary outcomes

  1. Patient global impression of improvement scale

    Time frame: day 15 and 30

    pain improvement scale from 1 to 7

  2. Side effects

    Time frame: Day 15 and 30

    Reporting side effects by patient

Sponsors and collaborators

Lead sponsor

St Joseph University, Beirut, Lebanon

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2026
First posted
Feb 23, 2017
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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