Status:
COMPLETED
PRF Treatment for Patients With Chronic Lumbosacral Radicular Pain Compared to Conventional Medical Management
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Ziekenhuis Oost-Limburg
Sint Jozef Hospital Bornem en Willebroek Belgium
Conditions:
Lumbosacral Radicular Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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). Pros...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00991237
Start Date
February 1 2010
End Date
December 1 2012
Last Update
October 24 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6217 jn