Pentoxifylline and Lumbar Radiculopathy

St Joseph University, Beirut, Lebanon

Status and phase

Active, not recruiting

Phase 4

Conditions

Lumbar Radiculopathy

Lumbar Disc Herniation

Lumbar Disc Disease

Treatments

Drug: Pentoxifylline Oral Tablet

Drug: Ibuprofen

Study type

Interventional

Funder types

Other

Identifiers

NCT03060434

Pento-LR

Details and patient eligibility

About

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

Full 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.

Enrollment

67 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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