PRF Treatment for Patients With Chronic Lumbosacral Radicular Pain Compared to Conventional Medical Management
NCT ID: NCT00991237
Last Updated: 2013-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
45 participants
INTERVENTIONAL
2010-02-28
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Prospective, single blinded, multicenter clinical trial.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pain reduction
Pulsed Radiofrequency
Pulsed Radiofrequency
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pulsed Radiofrequency
Pulsed Radiofrequency
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ziekenhuis Oost-Limburg
OTHER
Sint Jozef Hospital Bornem en Willebroek Belgium
UNKNOWN
Maastricht University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maarten v Kleef, Prof. dr.
Role: PRINCIPAL_INVESTIGATOR
Maastricht UMC+
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL28367.068.09
Identifier Type: -
Identifier Source: org_study_id