- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00991237
PRF Treatment for Patients With Chronic Lumbosacral Radicular Pain Compared to Conventional Medical Management
October 23, 2013 updated by: Maastricht University Medical Center
Pulsed Radiofrequency Treatment of the Lumbar Dorsal Root Ganglion for Patients With Chronic Lumbosacral Radicular Pain
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6217 jn
- Maastricht University Medical Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Pain reduction
|
Pulsed Radiofrequency
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain reduction
Time Frame: 2 months
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Maarten v Kleef, Prof. dr., Maastricht UMC+
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (ACTUAL)
December 1, 2012
Study Completion (ACTUAL)
December 1, 2012
Study Registration Dates
First Submitted
October 6, 2009
First Submitted That Met QC Criteria
October 6, 2009
First Posted (ESTIMATE)
October 7, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
October 24, 2013
Last Update Submitted That Met QC Criteria
October 23, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL28367.068.09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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