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OpenTrials
Completed

NCT Number: NCT00991237

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

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Centre

Maastricht, Limburg, 6217 jn, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsed Radiofrequency

Other

Pulsed Radiofrequency

Other names: PRF

Primary outcomes

  1. Pain reduction

    Time frame: 2 months

Secondary outcomes

  1. Quality of life

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Sint Jozef Hospital Bornem en Willebroek Belgium
  • Ziekenhuis Oost-Limburg

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 7, 2009
Registry last updated
Oct 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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