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RFNaTDD: Efficacy of Radiofrequency Nucleoplasty and Targeted Disc Decompression in Lumbar Radiculopathy

Sponsor
Ankara University (Other)
Overall Status
Completed
CT.gov ID
NCT02025283
Collaborator
(none)
73
Enrollment
1
Location
35
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Group Decompression or Group Nucleoplasty

Study Design

Study Type:
Observational
Actual Enrollment :
73 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
The Comparison of the Efficacy of Radiofrequency Nucleoplasty and Targeted Disc Decompression in Lumbar Radiculopathy: A Retrospective Review
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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.

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]
Other Names:
  • ArthroCare Spine
  • SpineCATH®

    		•
    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.

    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]
    Other Names:
  • ArthroCare Spine
  • SpineCATH®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Decrease in Visual Analogue Scale (VAS) [12 months]

    Secondary Outcome Measures

    1. More than 50% procedure-related patient satisfaction ratio in North American Spine Society Satisfaction Scale [12 months]

    Other Outcome Measures

    1. Decrease in Numerical Rating Scale [12 months]

    2. Decrease in Functional Rating Index [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ankara University Medical School Algology Department Ankara Turkey

    Sponsors and Collaborators

    • Ankara University

    Investigators

    • Principal Investigator: Barış Adaklı, Specialist, Ankara University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Barıs Adaklı, Specialist, Ankara University
    ClinicalTrials.gov Identifier:
    NCT02025283
    Other Study ID Numbers:
    • 10-402-13
    First Posted:
    Jan 1, 2014
    Last Update Posted:
    Jan 1, 2014
    Last Verified:
    Dec 1, 2013
    Keywords provided by Barıs Adaklı, Specialist, Ankara University
    Intervertebral disc disease
    Radiculopathy
    Chronic pain
    Thermocoagulation
    Additional relevant MeSH terms:
    Radiculopathy

    Study Results

    No Results Posted as of Jan 1, 2014