Trial of Pulsed Radiofrequency for Sciatica and Disc Herniation

NCT04209322 | Completed

• 1 other identifier: PRF003
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Sciatica; Lumbar Disc Herniation

Keywords

sciatica; lumbar disc herniation; radiofrequency; non invasive treatment

Outcome Measures

Primary Outcomes (1)

• Leg-Pain Intensity

  The primary outcome was the average leg-pain intensity score over the course of the previous 1 week (on a numerical pain-rating scale from 0 to 10, with 0 indicating no pain and 10 the worst possible pain; clinically important difference, 2 points), as assessed at 1 week and 52 weeks.

  52 weeks

Secondary Outcomes (3)

• Roland Morris disability questionnaire

  52 weeks

• Oswestry Disability Index questionnaire

  52 weeks

• Pain change questionnaire

  52 weeks

Other Outcomes (3)

• Adverse events

  52 weeks

• workplace absenteeism questionnaire

  52 weeks

• Satisfaction on current condition

  52 weeks

Study Arms (2)

Pulsed Radiofrequency

EXPERIMENTAL

Aseptic technique was adopted. Imaging guided (CT) catheter needle (active tip electrode) was inserted and a sensory stimulation test was carried out using an RF generator. The catheter needle was then advanced toward the DRG until the patient reported a tingling sensation and/or dysesthesia at less than 0.3V. PRF treatment was administered at 5 Hz and a 2 ms pulsed width for 10 minutes at 45V under the constraint that the electrode tip temperature not exceed 42°C. Finally, patients received 1mL lidocaine 20mg/mL mixed with 2mL dexamethasone 10mg/mL.

Procedure: pulsed Radiofrequency

Transforaminal Epidural Steroid Injection

ACTIVE COMPARATOR

Aseptic technique was adopted. Imaging guided (CT) catheter needle (active tip electrode) was inserted and a sensory stimulation test was carried out using an RF generator. The catheter needle was then advanced toward the DRG until the patient reported a tingling sensation and/or dysesthesia at less than 0.3V. After 10 minutes await (as per pRF), patients received 1mL lidocaine 20mg/mL mixed with 2mL dexamethasone 10mg/mL.

Procedure: Transforaminal Epidural Steroid Injection

Interventions

pulsed Radiofrequency PROCEDURE

Non-surgical treatment of lumbar disc herniation causing sciatica using pulsed radiofrequency (10 minutes) directed to the interested dorsal root ganglia (percutaneous technique); after radiofrequency application, using the same needle, steroid was administered (as per the control arm). The procedure was guided by CT imaging

Pulsed Radiofrequency

Transforaminal Epidural Steroid Injection PROCEDURE

Percutaneous injection of steroid in the nerve root foramen. The procedure was guided by CT imaging

Transforaminal Epidural Steroid Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients had radiologically confirmed disk herniation, and had received a diagnosis from an attending neurologist of an incapacitating lumbosacral radicular syndrome that had lasted for at least 12 weeks. Correlation of magnetic resonance imaging (MRI) findings with symptoms was required.
• The occurrence of another episode of symptoms similar to those of the current episode during the previous 12 months were not considered contraindications

You may not qualify if:

• Patients presenting with previous spine surgery, spondylolisthesis, cauda equina syndrome, muscle paralysis, or insufficient strength to move against gravity were excluded.
• Vertebral canal stenosis

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (2)

Centro Sana

Aprilia, LT, 04011, Italy

Location

Alessandro Napoli

Rome, 00100, Italy

Location

MeSH Terms

Conditions

Sciatica; Intervertebral Disc Displacement

Interventions

Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor of Radiology

Model Details: multicenter, prospective, randomized trial

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 24, 2019
• Study Start: February 1, 2017
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data are available to all authors for 5 years after main study completion

Locations

IT (2)