PRF Treatment for Patients With Chronic Lumbosacral Radic... | NCT00991237

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

NCT00991237

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Oct 24, 2013Estimated

Enrollment

45Actual

Phase

Not Applicable

Conditions

Lumbosacral Radicular Syndrome

Interventions

Pulsed Radiofrequency

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Oct 6, 2009

First Submission Date that Met QC Criteria

Oct 6, 2009

First Posted Date

Oct 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2013

Last Update Posted Date

Oct 24, 2013Estimated

Name	Class
Ziekenhuis Oost-Limburg	OTHER
Sint Jozef Hospital Bornem en Willebroek Belgium	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Label	Type	Description	Intervention Names
Pain reduction	Experimental		Other: Pulsed Radiofrequency

Name	Type	Description	Arm Group Labels	Other Names
Pulsed Radiofrequency	Other	Pulsed Radiofrequency	Pain reduction	PRF

Measure	Description	Time Frame
Pain reduction		2 months

Measure	Description	Time Frame
Quality of life		2 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D026741	Physical Therapy Modalities
D000078702	Radiofrequency Therapy