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

Not Applicable

Completed

• Conditions: Lumbosacral Radicular Syndrome
• Interventions: Other: Pulsed Radiofrequency

• Registration Number: NCT00991237
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-06
• Study First Submitted QC: 2009-10-06
• Study First Posted: 2009-10-07
• Study Start: 2010-02
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-23
• Last Update Posted: 2013-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pain reduction	Pulsed Radiofrequency	-

Primary Outcome Measures

Name	Time	Method
Pain reduction	2 months

Secondary Outcome Measures

Name	Time	Method
Quality of life	2 months

Trial Locations

Locations (1)

Maastricht University Medical Centre; 🇳🇱 Maastricht, Limburg, Netherlands