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

Pento-LR

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

2018-06-01

2022-12-01

2024-12-01

Active (not recruiting)

Early phase I

67

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The assessor and the investigator are unaware of the sequence of the 15 days treatment with pentoxifylline', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 67, 'type': 'ACTUAL'}}

2024-05-14