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Pentoxifylline and Lumbar Radiculopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03060434
Recruitment Status : Active, not recruiting
First Posted : February 23, 2017
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Joseph Maarrawi, 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

Condition or disease Intervention/treatment Phase
Lumbar Radiculopathy Lumbar Disc Herniation Lumbar Disc Disease Drug: Pentoxifylline Oral Tablet Drug: Ibuprofen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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)
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The assessor and the investigator are unaware of the sequence of the 15 days treatment with pentoxifylline
Primary Purpose: Treatment
Official Title: Prospective Controlled Crossover Study of the Role of Pentoxifylline in the Management of Lumbar Radiculopathy
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


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:
  • Ibuprofen
  • Paracetamol
  • pregabalin




Primary Outcome Measures :
  1. Numerical rating scale (NRS) [ Time Frame: At day 15 (and Day 30) ]
    Pain assessment by NRS


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060434


Locations
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Lebanon
Hotel Dieu de France Hospital
Beirut, Lebanon, 16 6830
Sponsors and Collaborators
St Joseph University, Beirut, Lebanon
Investigators
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Principal Investigator: Joseph Maarrawi, MD, PhD Hotel Dieu de France Hospital - Beirut, Lebanon, 16 6830
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Responsible Party: Dr Joseph Maarrawi, Associate Professor : Researcher - Pain Specialist - Neurosurgeon, St Joseph University, Beirut, Lebanon
ClinicalTrials.gov Identifier: NCT03060434    
Other Study ID Numbers: Pento-LR
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Joseph Maarrawi, St Joseph University, Beirut, Lebanon:
pentoxifylline
Disc hernia
sciatica
lumbar radiculopathy
Additional relevant MeSH terms:
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Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Acetaminophen
Ibuprofen
Pregabalin
Pentoxifylline
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antipyretics
Phosphodiesterase Inhibitors
Platelet Aggregation Inhibitors