Pentoxifylline and Lumbar Radiculopathy

Phase 4Active Not RecruitingNCT03060434

St Joseph University, Beirut, Lebanon67 enrolled

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Lumbar Radiculopathy Lumbar Disc Herniation Lumbar Disc Disease

Interventions

Pentoxifylline Oral TabletDRUG

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

IbuprofenDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Hotel Dieu de France Hospital

Beirut, Lebanon

Outcomes

Primary Outcomes

Numerical rating scale (NRS)

Pain assessment by NRS

Time frame: At day 15 (and Day 30)

Secondary Outcomes

Patient global impression of improvement scale

pain improvement scale from 1 to 7

Time frame: day 15 and 30

Side effects

Reporting side effects by patient

Time frame: Day 15 and 30

Data from ClinicalTrials.gov

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