Efficacy of Radiofrequency Nucleoplasty and Targeted Disc Decompression in Lumbar Radiculopathy

Completed

• Conditions: Pain Measurement; Visual Analogue Pain Scale
• Interventions: Procedure: Group Decompression or Group Nucleoplasty

• Registration Number: NCT02025283
• Lead Sponsor: Ankara University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-12
• Study First Submitted: 2013-12-24
• Study First Submitted QC: 2013-12-30
• Last Update Submitted: 2013-12-30
• Study First Posted: 2014-01-01
• Last Update Posted: 2014-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group Decompression	Group Decompression or Group Nucleoplasty	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.
Group Nucleoplasty	Group Decompression or 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.

Primary Outcome Measures

Name	Time	Method
Decrease in Visual Analogue Scale (VAS)	12 months

Secondary Outcome Measures

Name	Time	Method
More than 50% procedure-related patient satisfaction ratio in North American Spine Society Satisfaction Scale	12 months

Trial Locations

Locations (1)

Ankara University Medical School Algology Department; 🇹🇷 Ankara, Turkey