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

Primary Purpose

Lumbosacral Radicular Syndrome

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Pulsed Radiofrequency
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbosacral Radicular Syndrome focused on measuring NRS, GPE, pain reduction, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Maastricht University Medical Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pain reduction

Arm Description

Outcomes

Primary Outcome Measures

Pain reduction

Secondary Outcome Measures

Quality of life

Full Information

First Posted
October 6, 2009
Last Updated
October 23, 2013
Sponsor
Maastricht University Medical Center
Collaborators
Ziekenhuis Oost-Limburg, Sint Jozef Hospital Bornem en Willebroek Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT00991237
Brief Title
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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Ziekenhuis Oost-Limburg, Sint Jozef Hospital Bornem en Willebroek Belgium

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbosacral Radicular Syndrome
Keywords
NRS, GPE, pain reduction, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pain reduction
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Pulsed Radiofrequency
Other Intervention Name(s)
PRF
Intervention Description
Pulsed Radiofrequency
Primary Outcome Measure Information:
Title
Pain reduction
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maarten v Kleef, Prof. dr.
Organizational Affiliation
Maastricht UMC+
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6217 jn
Country
Netherlands

12. IPD Sharing Statement

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

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