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

Pulsed Radiofrequency Treatment of the Lumbar Dorsal Root Ganglion for Patients With Chronic Lumbosacral Radicular Pain

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00991237

Enrollment

Registered

2009-10-07

Start date

2010-02-28

Completion date

2012-12-31

Last updated

2013-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbosacral Radicular Syndrome

Keywords

NRS, GPE, pain reduction, quality of life

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.

Interventions

OTHERPulsed Radiofrequency

Pulsed Radiofrequency

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pain reduction	2 months

Secondary

Measure	Time frame
Quality of life	2 months

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026