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NCT03060434 Clinical Trial

Pentoxifylline and Lumbar Radiculopathy

Lumbar Disc Herniation Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03060434
Other study ID # Pento-LR
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date June 1, 2018
Est. completion date December 1, 2024

Study information
Verified date May 2024
Source St Joseph University, Beirut, Lebanon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 67
Est. completion date December 1, 2024
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Lebanon Hotel Dieu de France Hospital Beirut

Sponsors (1)
Lead Sponsor Collaborator
St Joseph University, Beirut, Lebanon

Country where clinical trial is conducted

Lebanon, 

Outcome
Type Measure Description Time frame Safety issue
Primary Numerical rating scale (NRS) Pain assessment by NRS At day 15 (and Day 30)
Secondary Patient global impression of improvement scale pain improvement scale from 1 to 7 day 15 and 30
Secondary Side effects Reporting side effects by patient Day 15 and 30
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