Efficacy of Radiofrequency Nucleoplasty and Targeted Disc Decompression in Lumbar Radiculopathy

Pain Measurement Clinical Trial

— RFNaTDD  

Official title:

The Comparison of the Efficacy of Radiofrequency Nucleoplasty and Targeted Disc Decompression in Lumbar Radiculopathy: A Retrospective Review

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025283
• Other study ID #: 10-402-13
• Status: Completed
• Phase: N/A
• First received: December 24, 2013
• Last updated: December 30, 2013
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pain Measurement
• Radiculopathy
• Visual Analogue Pain Scale

Intervention

Procedure:
• Group Decompression or Group Nucleoplasty
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]

Locations

Country	Name	City	State
Turkey	Ankara University Medical School Algology Department	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Decrease in Numerical Rating Scale		12 months	Yes
Other	Decrease in Functional Rating Index		12 months	Yes
Primary	Decrease in Visual Analogue Scale (VAS)		12 months	Yes
Secondary	More than 50% procedure-related patient satisfaction ratio in North American Spine Society Satisfaction Scale		12 months	Yes