PRF Treatment for Patients With Chronic Lumbosacral Radicular Pain Compared to Conventional Medical Management

This study has been completed.
Ziekenhuis Oost-Limburg
Sint Jozef Hospital Bornem en Willebroek Belgium
Information provided by (Responsible Party):
Maastricht University Medical Center Identifier:
First received: October 6, 2009
Last updated: October 23, 2013
Last verified: October 2013

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 Intervention
Lumbosacral Radicular Syndrome
Other: Pulsed Radiofrequency

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Pulsed Radiofrequency Treatment of the Lumbar Dorsal Root Ganglion for Patients With Chronic Lumbosacral Radicular Pain

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Pain reduction [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: February 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pain reduction Other: Pulsed Radiofrequency
Pulsed Radiofrequency
Other Name: PRF


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: 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+
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center Identifier: NCT00991237     History of Changes
Other Study ID Numbers: NL28367.068.09
Study First Received: October 6, 2009
Last Updated: October 23, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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 processed this record on April 17, 2014