Pentoxifylline and Lumbar Radiculopathy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lumbar Radiculopathy, Lumbar Disc Herniation, Lumbar Disc Disease

Intervention / Treatment
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* Drug: Pentoxifylline Oral Tablet
* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Ibuprofen | Drug: Ibuprofen<br>* patient will receive for 15 days: Ibuprofen 600 mg bid; pregabalin 75 mg bid; paracetamol 1 g tid<br>* Other names: pregabalin;|
| Experimental: Pentoxifylline<br>Pentoxifylline oral tablets | Drug: Pentoxifylline Oral Tablet<br>* patient will receive for 15 days: Ibuprofen 600 mg bid; pregabalin 75 mg bid; paracetamol 1 g tid; pentoxifylline 400 mg bid<br>* Other names: pregabalin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating scale (NRS) | 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 | pain improvement scale from 1 to 7 | day 15 and 30 | 
| Side effects | Reporting side effects by patient | Day 15 and 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pentoxifylline, Disc hernia, sciatica, lumbar radiculopathy