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

NCT00991237 | Completed DMC

• 1 other identifier: NL28367.068.09
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbosacral Radicular Syndrome

Keywords

NRS; GPE; pain reduction; quality of life

Outcome Measures

Primary Outcomes (1)

• Pain reduction

  2 months

Secondary Outcomes (1)

• Quality of life

  2 months

Study Arms (1)

Pain reduction

EXPERIMENTAL

Other: Pulsed Radiofrequency

Interventions

Pulsed Radiofrequency OTHER

Pulsed Radiofrequency

Also known as: PRF

Pain reduction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Ziekenhuis Oost-Limburg: collaborator
• Sint Jozef Hospital Bornem en Willebroek Belgium: collaborator

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6217 jn, Netherlands

Location

MeSH Terms

Interventions

Pulsed Radiofrequency Treatment

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Study Officials

• Maarten v Kleef, Prof. dr.

  Maastricht UMC+

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2009
• First Posted: October 7, 2009
• Study Start: February 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 24, 2013

Record last verified: 2013-10

Locations

NL (1)