PRF Treatment for Patients With Chronic Lumbosacral Radicular Pain Compared to Conventional Medical 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. Identifier: NCT00991237
Recruitment Status : Completed
First Posted : October 7, 2009
Last Update Posted : October 24, 2013
Ziekenhuis Oost-Limburg
Sint Jozef Hospital Bornem en Willebroek Belgium
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:

The purpose of the study is to evaluate the effect of PRF treatment adjacent to the lumbar dorsal root ganglion (DRG) of L5 or S1 in patients with a chronic lumbosacral radicular syndrome (LRS).

Prospective, single blinded, multicenter clinical trial.

Condition or disease Intervention/treatment Phase
Lumbosacral Radicular Syndrome Other: Pulsed Radiofrequency Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Pulsed Radiofrequency Treatment of the Lumbar Dorsal Root Ganglion for Patients With Chronic Lumbosacral Radicular Pain
Study Start Date : February 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: Pain reduction Other: Pulsed Radiofrequency
Pulsed Radiofrequency
Other Name: PRF

Primary Outcome Measures :
  1. Pain reduction [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 2 months ]

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Symptoms more than 3 months 18,48
  • Optimized conventional medical management at least for 1 month
  • Pain radiating into the leg, up to the hallux (big toe) (L5) or little toe (S1)
  • The pain in the leg dominates over a possible lumbalgia, the average pain in the leg measured 3 times a day, at predefined time points, over 4 consecutive days prior to inclusion should be more than 5 (NRS 10-point scale) 8
  • Pattern of radiation suggestive for L5 or S1 pathology 49,50
  • One or more positive neurological tests of nerve root tension or neurological deficit 51 ; straight leg raising test (SLRT), contralateral SLRT, motor reaction during SLRT and passive cervical flexion, motor reaction during passive cervical flexion while bending forward in standing position
  • Capable of understanding the information relative to the treatment and procedure and willing to provide informed consent
  • Capable of understanding and filling-out the questionnaires necessary for evaluation of the treatments
  • Patients having undergone low back surgery like discectomy with or without laminectomy are allowed to participate in the study

Exclusion Criteria:

  • Patients younger than 18 years
  • Malignant disorder or currently under treatment for a malignant disorder
  • Previous lumbar fractures
  • Proven myelum lesion or abnormalities in the central neurological structures
  • Systemic or connective tissue diseases
  • Diabetes mellitus type I
  • Multiple sclerosis
  • Coagulation disorders
  • Pregnancy
  • Conventional medical management less then 1 month
  • Pain Catastrophizing Scale > 45. When the patient has a higher score he/she will first be referred to a psychologist for consultation 52
  • Leg pain due to localized hip or knee pathology
  • Patients with a pacemaker or neurostimulator
  • Patients previously treated with RF or PRF of the lumbar DRG

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 identifier (NCT number): NCT00991237

Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6217 jn
Sponsors and Collaborators
Maastricht University Medical Center
Ziekenhuis Oost-Limburg
Sint Jozef Hospital Bornem en Willebroek Belgium
Principal Investigator: Maarten v Kleef, Prof. dr. Maastricht UMC+

Responsible Party: Maastricht University Medical Center Identifier: NCT00991237     History of Changes
Other Study ID Numbers: NL28367.068.09
First Posted: October 7, 2009    Key Record Dates
Last Update Posted: October 24, 2013
Last Verified: October 2013

Keywords provided by Maastricht University Medical Center:
pain reduction
quality of life

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases