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CompletedNCT00991237Updated Oct 24, 2013

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

An interventional study of Pulsed Radiofrequency in Lumbosacral Radicular Syndrome, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-24.

Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Lumbosacral Radicular Syndrome

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Keywords

  • NRS
  • GPE
  • pain reduction
  • quality of life
03

In context

Radiculopathy

488 studies on the registry are indexed under Radiculopathy; 141 are open to participants now.

This study's enrollment of 45 is below the median of 60 across 376 interventional studies indexed under Radiculopathy.

Browse Radiculopathy studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Pain reduction

    Other: Pulsed Radiofrequency

Interventions

  • OtherPulsed Radiofrequency

    Pulsed Radiofrequency

    Also known as: PRF

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What researchers measure

Primary outcomes

  1. Pain reduction

    Time frame: 2 months

Secondary outcomes

  1. Quality of life

    Time frame: 2 months

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Study locations

1 site
  • Maastricht University Medical Centre
    Maastricht, Limburg 6217 jn, Netherlands
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00991237
Lead sponsor
Maastricht University Medical Center
Collaborators
Ziekenhuis Oost-Limburg, Sint Jozef Hospital Bornem en Willebroek Belgium
Responsible party
Sponsor
First posted
Oct 7, 2009
Start date
Feb 2010
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Oct 24, 2013

Study contacts

Maarten v Kleef, Prof. dr.
principal investigator · Maastricht UMC+

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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