Pentoxifylline and Lumbar Radiculopathy

Sponsor

St Joseph University, Beirut, Lebanon (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03060434

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Lumbar Radiculopathy Lumbar Disc Herniation Lumbar Disc Disease	Drug: Pentoxifylline Oral Tablet Drug: Ibuprofen	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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)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:

Double (Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Ibuprofen	Drug: Ibuprofen patient will receive for 15 days: Ibuprofen 600 mg bid; pregabalin 75 mg bid; paracetamol 1 g tid Other Names: Paracetamol pregabalin
Experimental: Pentoxifylline Pentoxifylline oral tablets	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 Other Names: Ibuprofen Paracetamol pregabalin

Arm

Intervention/Treatment

Active Comparator: Control

Ibuprofen

Drug: Ibuprofen

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

Other Names:

Paracetamol

pregabalin

Experimental: Pentoxifylline

Pentoxifylline oral tablets

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

Other Names:

Ibuprofen

Paracetamol

pregabalin

Outcome Measures

Primary Outcome Measures

Numerical rating scale (NRS) [At day 15 (and Day 30)]
Pain assessment by NRS

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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