Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02930057
Recruitment Status : Unknown
Verified October 2016 by Dr. Vadim Tashlikov, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 11, 2016
Last Update Posted : October 17, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Vadim Tashlikov, Sheba Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Radicular; Neuropathic, Lumbar, Lumbosacral Low Back Pain Back Pain With Radiation Drug: Celestone Procedure: pulsed radiofrequency treatment Drug: Control Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transforaminal Epidural Steroid Injection in Conjunction With Pulsed Radiofrequency Treatment of the Lumbar Dorsal Root Ganglion for the Management of Chronic Lumbosacral Radicular Pain: a Randomized, Double-blind Trial
Study Start Date : October 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2018


Arm Intervention/treatment
Experimental: Celestone
all 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.
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).

Control
all 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.
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.




Primary Outcome Measures :
  1. pain scores [ Time Frame: before the procedure and at 1, 2 and 3 months after the treatment ]
    Changes in pain scores, as reported by the patients via the NRS scores, will be analyzed before the procedure and at 1, 2 and 3 months after the treatment

  2. quality of life and activities of daily living [ Time Frame: before the procedure and at 1, 2 and 3 months after the treatment ]
    The potential changes in quality of life and activities of daily living will be measured by validated Roland Disability Questionnaire or Oswestry Disability Index scores


Secondary Outcome Measures :
  1. adverse events [ Time Frame: immediately and for up to 72 hours after the treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men and women
  • age ≥18 years old,
  • pain intensity≥4 out of 10 on the numerical rating scale (NRS),
  • chronic lumbosacral radicular pain lasting ≥12 weeks,
  • dominant leg pain with less intense back pain,
  • the previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications.
  • segmental pain of a radicular nature originating from the lumbar segments and with a shooting or lancinating quality corresponding to a dermatome suggestive of the involved nerve root.
  • availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features.

Exclusion Criteria:

  • patient refusal to participate in the study,
  • age <18 years,
  • pregnant or nursing
  • pain <4-points on NRS,
  • acute pain of onset lasting<12 weeks,
  • progressive motor weakness in the affected leg,
  • allergies to local anesthetics, contrast dyes or steroids
  • significant anatomic deformity (either congenital or acquired) making it difficult to access the foramen as evidenced by computed tomography/magnetic resonance imaging
  • presence of cancer accounting for back pain
  • patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment
  • steroid injection within the previous 12 weeks,
  • systemic infection,
  • injection site infection,
  • unstable medical or psychiatric condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02930057


Contacts
Layout table for location contacts
Contact: Vadim Tashlikov, M.D. 0504820159 ext +972 vtashl@gmail.com
Contact: Dmitry Shklovsky, M.D. 0524774479 ext +972 dm86sh@gmail.com

Sponsors and Collaborators
Sheba Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Vadim Tashlikov, M.D. Sheba Medical Center Hospital, Israel

Publications:
11. Sluijter ME, Cosman ER, Rittman IIWB, van Kleef M. The effects of pulsed radiofrequency field applied to the dorsal root ganglion—A preliminary report. The Pain Clinic 1998;11(2):109-17.
Bhargava A, DePalma MJ, Ludwig S, Gelb D, Slipman CW. Injection therapy for lumbar radiculopathy.Curr OpinOrthop 2005;16:152-7

Layout table for additonal information
Responsible Party: Dr. Vadim Tashlikov, Senior Doctor, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02930057     History of Changes
Other Study ID Numbers: 3301-16-SMC
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Vadim Tashlikov, Sheba Medical Center:
lumbar dorsal root ganglion
transforaminal epidural steroid injection
chronic lumbosacral radicular pain
pulsed radiofrequency treatment
betamethasone
dorsal root ganglion
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuromuscular Diseases
Lidocaine
Radiculopathy
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Peripheral Nervous System Diseases
Nervous System Diseases
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Pharmaceutical Solutions
Betamethasone sodium phosphate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones