STUDY PROTOCOL - pulsed radiofrequency in addition to transforaminal epidural steroid injection in patients with acute and subacute sciatica due to lumbosacral disc herniation: rationale and design of a phase III, multicenter, randomized, controlled trial

Autor: Simone Napoli, Alessandro Napoli, Emanuela Panella, Alessandro De Maio, Nunziante Pandaloro, Roberto Scipione, Alberto Bazzocchi, Paolo Spinnato, Giancarlo Facchini, Luca Bianchi, Ugo Albisinni, Carlo Catalano, Giulia Alfieri
Rok vydání: 2020
Předmět:
musculoskeletal diseases
medicine.medical_specialty
Disc herniation
medicine.medical_treatment
Biomedical Engineering
Injections
Epidural
030204 cardiovascular system & hematology
law.invention
03 medical and health sciences
Sciatica
0302 clinical medicine
Randomized controlled trial
law
disc herniation
pain
PRF
sciatica
TFESI
acute disease
combined modality therapy
humans
injections
epidural
intervertebral disc displacement
outcome assessment
health care
prospective studies
steroids
treatment outcome
pulsed radiofrequency treatment
Outcome Assessment
Health Care
medicine
Humans
In patient
Limited evidence
Prospective Studies
business.industry
Epidural steroid injection
Pulsed radiofrequency
General Medicine
Combined Modality Therapy
nervous system diseases
Surgery
Pulsed Radiofrequency Treatment
Treatment Outcome
Acute Disease
Steroids
medicine.symptom
business
030217 neurology & neurosurgery
Lumbosacral joint
Intervertebral Disc Displacement
Zdroj: Expert review of medical devices. 17(9)
ISSN: 1745-2422
Popis: Lumbosacral disc herniation (LDH) represents the most common cause of sciatica. Currently, there is limited evidence about minimally invasive interventional therapies for the treatment of this condition. This paper presents the protocol for a multicenter, prospective, randomized, controlled, phase III trial evaluating if PRF in addition to TFESI leads to better outcomes in patients with sciatica due to LDH, compared to TFESI alone, during the first year after treatment (Pulsed Radiofrequency in Addition to TFESI for Sciatica [PRATS]). Eligible patients are between 18 and 75 years of age, suffer from sciatica of less than 12-week duration with pain intensity4 on the Visual Analogue Scale (VAS) and have unilateral LDH compatible with symptoms at MRI. The Medical Ethics Committee of participating hospitals approved the study protocol. Patients will be randomized to receive either combined treatment (PRF and TFESI) or TFESI alone. The primary outcome will be the assessment of pain intensity with VAS at different timepoints from week-1 to 52 after treatment; secondary outcomes will include Roland Disability Questionnaire for sciatica and Oswestry Disability Index, evaluated at 4, 12 and 52 weeks. The follow-up will last 52 weeks for each patient. Statistical analysis will be performed on a per-protocol basis.
Databáze: OpenAIRE
Externí odkaz: