Pentoxifylline and Lumbar Radiculopathy

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03060434

Enrollment

Registered

2017-02-23

Start date

2018-06-01

Completion date

2026-12-01

Last updated

2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Disc Disease, Lumbar Disc Herniation, Lumbar Radiculopathy

Keywords

pentoxifylline, Disc hernia, sciatica, lumbar radiculopathy

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

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.

Interventions

DRUGPentoxifylline Oral Tablet

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

DRUGIbuprofen

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Masking description

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

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)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Numerical rating scale (NRS)	At day 15 (and Day 30)	Pain assessment by NRS

Secondary

Measure	Time frame	Description
Patient global impression of improvement scale	day 15 and 30	pain improvement scale from 1 to 7
Side effects	Day 15 and 30	Reporting side effects by patient

Countries

Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026