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Transforaminal Epidural Steroid Injection With Pulsed Radiofrequency for Chronic Lumbosacral Radicular Pain Management

NCT02930057 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-10-17

No results posted yet for this study

Summary

The purpose of this study is to examine the potential changes in levels of pain, quality of life (QoL) and activities of daily living (ADL) observed when transforaminal epidural steroid injection is administered in conjunction with pulsed radiofrequency treatment of the lumbar dorsal root ganglion during the initial 3 months follow-up period. Safety (monitoring side effects) of the treatment is determined.

The study hypothesis is that the application of transforaminal epidural steroid injection (TFESI) in conjunction with pulsed radiofrequency treatment (PRF) treatment of the lumbar dorsal root ganglion would increase the treatment response of PRF and thereby provide a measurable difference in the pain scores, quality of life and activities of daily living for the patients suffering from chronic lumbosacral radicular pain.

Conditions

  • Radicular; Neuropathic, Lumbar, Lumbosacral
  • Low Back Pain
  • Back Pain With Radiation

Interventions

DRUG

Celestone

all of the patients of the experimental Celestone group will receive transforaminal epidural injection of the solution of 1 cc of Lidocaine 1% with 1 cc of Celestone® Chronodose® around each dorsal root ganglion immediately after the radiofrequency treatment has been performed

PROCEDURE

pulsed radiofrequency treatment

all of the patients who will participate in the study will receive pulsed radiofrequency treatment adjacent to lumbosacral dorsal root ganglion(s).

DRUG

Control

all of the patients of the control group will receive transforaminal epidural injection of the solution of 1 cc of Lidocaine 1% with 1 cc of normal saline around each dorsal root ganglion immediately after the radiofrequency treatment will be performed.

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Vadim Tashlikov, M.D. · Sheba Medical Center Hospital, Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-10-31
Completion
2018-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02930057 on ClinicalTrials.gov