Pentoxifylline and Lumbar Radiculopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2026-12-01

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

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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.

Conditions

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Lumbar Radiculopathy Lumbar Disc Herniation Lumbar Disc Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

The assessor and the investigator are unaware of the sequence of the 15 days treatment with pentoxifylline

Study Groups

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Control

Ibuprofen

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

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

Pentoxifylline

Pentoxifylline oral tablets

Group Type EXPERIMENTAL

Pentoxifylline Oral Tablet

Intervention Type DRUG

patient will receive for 15 days: Ibuprofen 600 mg bid; pregabalin 75 mg bid; paracetamol 1 g tid; pentoxifylline 400 mg bid

Interventions

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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

Intervention Type DRUG

Ibuprofen

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

Intervention Type DRUG

Other Intervention Names

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Ibuprofen Paracetamol pregabalin Paracetamol pregabalin

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No