NCT04209322: PRATS

Trial of Pulsed Radiofrequency for Sciatica and Disc Herniation

Completed NA Last updated 29 March 2022

What this trial tests

NA trial testing pulsed Radiofrequency in Sciatica in 250 participants. Completed in 31 January 2020.

Timeline

1 February 2017

Primary endpoint
31 January 2020

31 January 2020

Quick facts

Lead sponsor	University of Roma La Sapienza
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	250
Start date	1 February 2017
Primary completion	31 January 2020
Estimated completion	31 January 2020
Sites	2 locations across Italy

Drugs / interventions tested

• pulsed Radiofrequency
• Transforaminal Epidural Steroid Injection — full drug profile →

Conditions studied

• Sciatica — all drugs for Sciatica →
• Lumbar Disc Herniation — all drugs for Lumbar Disc Herniation →

Sponsor

University of Roma La Sapienza

Who can join

Adults 18 to 75, any sex, with Sciatica or Lumbar Disc Herniation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Transforaminal epidural injection of treatments, commonly steroids (TFESI), is offered to people with sciatica and might improve symptoms, reduce disability and speed up return to normal activities (NICE guidelines) Imaging-guided TFESI has traditionally been performed in the sciatica context because injection is administered directly to the nerve root, which relieves the pain markedly; however, the maintenance time is usually short.

Treatment with radiofrequency for pain management is in clinical use since decades primarily with nerve lesioning (thermoablation) once the specific pain tributary nerve is identified.

Pulsed radiofrequency (PRF) with neuromodulation intention (not lesioning) has been shown to be effective in reducing some types of chronic pain, both degenerative and neuropathic.

Pulsed radiofrequency has been also extensively used in the context of acute and subacute sciatica due to disc herniation without sufficient level of evidence. In a prospective RCT, comparing prf directed to dorsal root ganglia and Tfesi in patients with sciatica did not allow conclusions on efficacy because of limitations of the trial. In that trial, only few participants completed the study due to violation of trial protocol translating the results as not consistent.

One retrospective trial, in which the use of Prf in addition to tfesi was evaluated in patients with acute and subacute sciatica, demonstrated rapid pain relief onset and prolonged maintenance; the overall efficacy was superior to that of the single method treatment (either tfsei or prf).

The investigators conducted a randomized, double-blind, controlled trial (Pulsed Radiofrequency in Addition to Tfesi for Sciatica \[PRATS\]) to determine if PRF in addition to TFESI leads to better outcomes in the management of patients with acute and subacute sciatica due to disc herniation, compared to TFESI alone.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. CT-guided Pulsed Radiofrequency Combined with Steroid Injection for Sciatica from Herniated Disk: A Randomized Trial.
   Napoli A, Alfieri G, De Maio A, Panella E, et al · · 2023 · cited 12× · PMID 36975815 · DOI 10.1148/radiol.221478