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

CompletedNot applicableNCT00991237
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Pulsed Radiofrequency Treatment of the Lumbar Dorsal Root Ganglion for Patients With Chronic Lumbosacral Radicular Pain
Conditions
  • Lumbosacral Radicular Syndrome
Interventions
  • Other: Pulsed Radiofrequency
Sponsor
Maastricht University Medical Center
Collaborators
Ziekenhuis Oost-Limburg; Sint Jozef Hospital Bornem en Willebroek Belgium
Start date
2010-02
Primary completion
2012-12
Sex
All
Age range
from 18 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
Netherlands
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00991237