Efficacy of Radiofrequency Nucleoplasty and Targeted Disc Decompression in Lumbar Radiculopathy (RFNaTDD)
December 30, 2013 updated by: Barıs Adaklı, Ankara University
The Comparison of the Efficacy of Radiofrequency Nucleoplasty and Targeted Disc Decompression in Lumbar Radiculopathy: A Retrospective Review
The aim of this study is to compare early and long term efficacy of lumbar radiofrequency nucleoplasty and targeted disc decompression in patients with lumbar radiculopathy who failed previous conventional therapy.
Medical records of 37 patients undergoing targeted disc decompression, 36 patients undergoing lumbar radiofrequency nucleoplasty were retrospectively examined.Visual Analogue Scale (VAS), Numerical Rating Scale (NRS), Functional Rating Index, Backache index, Oswestry Lumbar Back Pain Disability Index, Rolland-Morris Lumbar Back Pain Questionnaire scales were used before treatment and 1,6,12 months after the procedure.
North American Spine Society Satisfaction Scale was used at 12th month after the procedure.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
73
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey
- Ankara University Medical School Algology Department
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
120 patients with lumbar radiculopathy undergoing nucleoplasty and targetted disc decompression in Algology Department of a University Hospital between 2010 and 2012 were retrospectively evaluated and complete data of only 73 patients were reached and they were included to the study
Description
Inclusion Criteria:
- patients having radicular pain with or without low back pain for at least 6 weeks inspite of conservative treatment who have unsequestrated, bulging, protruded or extruded hernia confirmed with MRI.
Exclusion Criteria:
- patients having a more than 50% loss in disc area, sequestrated disc, the presence of vertebra fracture or tumor, the patients having spinal stenosis or spondylolisthesis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Group Decompression
Group Decompression: Patients assigned to Group Decompression.
After determination of the appropriate space for the approach under fluoroscopy guidance, a 17 gauge trochar needle was advanced posterolaterally up to the center of the disc.
Then site verification was done again with water soluble contrast material under floroscopy guidance.
Then flexible intradiscal decompression catheter (SpineCATH®, Smith & Nephew, Memphis, TN) were advanced inside the trochar needle towards the disc and decompression was performed.
After being sure of achieving sufficient decompression inside the disc, the decompression device were removed under fluoroscopy guidance and the incision site was closed and the patients were recommended to have bedrest for 2 hours.
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Group Decompression: Decompression with flexible intradiscal decompression catheter (SpineCATH®, Smith & Nephew, Memphis, TN) Group Nucleoplasty: Nucleoplasty with radiofrequency-compatible needle (Coblation: Perc DLE SpineWandTM [ArthroCare Spine, Sunnyvale, CA]
Other Names:
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Group Nucleoplasty
Group Nucleoplasty : Patients assigned to Group Nucleoplasty.
After determination of the appropriate space for the approach under fluoroscopy guidance, a 17 gauge trochar needle was advanced posterolaterally up to the center of the disc.
Then site verification was done again with water soluble contrast material under floroscopy guidance.
Then radiofrequency-compatible needle (Coblation: Perc DLE SpineWandTM [ArthroCare Spine, Sunnyvale, CA] were advanced inside the trochar needle towards the disc and nucleoplasty was performed.
After being sure of achieving sufficient decompression inside the disc, the nucleoplasty probe was removed under fluoroscopy guidance and the incision site was closed and the patients were recommended to have bedrest for 2 hours.
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Group Decompression: Decompression with flexible intradiscal decompression catheter (SpineCATH®, Smith & Nephew, Memphis, TN) Group Nucleoplasty: Nucleoplasty with radiofrequency-compatible needle (Coblation: Perc DLE SpineWandTM [ArthroCare Spine, Sunnyvale, CA]
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Decrease in Visual Analogue Scale (VAS)
Time Frame: 12 months
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12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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More than 50% procedure-related patient satisfaction ratio in North American Spine Society Satisfaction Scale
Time Frame: 12 months
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12 months
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Decrease in Numerical Rating Scale
Time Frame: 12 months
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12 months
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Decrease in Functional Rating Index
Time Frame: 12 months
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Barış Adaklı, Specialist, Ankara University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (ACTUAL)
December 1, 2012
Study Completion (ACTUAL)
December 1, 2012
Study Registration Dates
First Submitted
December 24, 2013
First Submitted That Met QC Criteria
December 30, 2013
First Posted (ESTIMATE)
January 1, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
January 1, 2014
Last Update Submitted That Met QC Criteria
December 30, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-402-13
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