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

This study has been completed.
Sponsor:
Collaborators:
Ziekenhuis Oost-Limburg
Sint Jozef Hospital Bornem en Willebroek Belgium
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00991237
First received: October 6, 2009
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991237

Locations
Netherlands
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
Investigators
Principal Investigator: Maarten v Kleef, Prof. dr. Maastricht UMC+
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov 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:
NRS
GPE
pain reduction
quality of life

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

ClinicalTrials.gov processed this record on July 20, 2014