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Pentoxifylline and Lumbar Radiculopathy

Primary Purpose

Lumbar Radiculopathy, Lumbar Disc Herniation, Lumbar Disc Disease

Status

Active

Phase

Phase 4

Locations

Lebanon

Study Type

Interventional

Intervention

Pentoxifylline Oral Tablet

Ibuprofen

About this trial

This is an interventional treatment trial for Lumbar Radiculopathy focused on measuring pentoxifylline, Disc hernia, sciatica, lumbar radiculopathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hotel Dieu de France Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Pentoxifylline

Arm Description

Ibuprofen

Pentoxifylline oral tablets

Outcomes

Primary Outcome Measures

Numerical rating scale (NRS)

Pain assessment by NRS

Secondary Outcome Measures

Patient global impression of improvement scale

pain improvement scale from 1 to 7

Side effects

Reporting side effects by patient

Full Information

NCT ID

NCT03060434

First Posted

February 18, 2017

Last Updated

April 18, 2023

Sponsor

St Joseph University, Beirut, Lebanon

1. Study Identification

Unique Protocol Identification Number

NCT03060434

Brief Title

Pentoxifylline and Lumbar Radiculopathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

December 1, 2022 (Actual)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

St Joseph University, Beirut, Lebanon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lumbar Radiculopathy, Lumbar Disc Herniation, Lumbar Disc Disease

Keywords

pentoxifylline, Disc hernia, sciatica, lumbar radiculopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

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)

Masking

InvestigatorOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Ibuprofen

Arm Title

Pentoxifylline

Arm Type

Experimental

Arm Description

Pentoxifylline oral tablets

Intervention Type

Drug

Intervention Name(s)

Pentoxifylline Oral Tablet

Other Intervention Name(s)

Ibuprofen, Paracetamol, pregabalin

Intervention Description

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

Intervention Name(s)

Ibuprofen

Other Intervention Name(s)

Paracetamol, pregabalin

Intervention Description

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

Primary Outcome Measure Information:

Title

Numerical rating scale (NRS)

Description

Pain assessment by NRS

Time Frame

At day 15 (and Day 30)

Secondary Outcome Measure Information:

Title

Patient global impression of improvement scale

Description

pain improvement scale from 1 to 7

Time Frame

day 15 and 30

Title

Side effects

Description

Reporting side effects by patient

Time Frame

Day 15 and 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Maarrawi, MD, PhD

Organizational Affiliation

Hotel Dieu de France Hospital - Beirut, Lebanon, 16 6830

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hotel Dieu de France Hospital

City

Beirut

ZIP/Postal Code

16 6830

Country

Lebanon

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pentoxifylline and Lumbar Radiculopathy

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