Clinical trial NCT00991237: PRF Treatment for Patients With Chronic Lumbosacral Radicular Pain Compared to Conventional Medical Management
Official title: Pulsed Radiofrequency Treatment of the Lumbar Dorsal Root Ganglion for Patients With Chronic Lumbosacral Radicular Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbosacral Radicular Syndrome
Keywords: NRS
GPE
pain reduction
quality of life
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
name: Sint Jozef Hospital Bornem en Willebroek Belgium
First posted: 2009-10-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Pain reduction
timeFrame: 2 months
Secondary outcomes:
measure: Quality of life
timeFrame: 2 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
Study officials:
affiliation: Maastricht UMC+
name: Maarten v Kleef, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: