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Completed

NCT Number: NCT02025283

Efficacy of Radiofrequency Nucleoplasty and Targeted Disc Decompression in Lumbar Radiculopathy

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.

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Key information

Conditions

Visual Analogue Pain Scale Chronic Pain Intervertebral disc disease Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pain Measurement Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University Medical School Algology Department

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group Decompression or Group Nucleoplasty

Procedure

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®

Primary outcomes

  1. Decrease in Visual Analogue Scale (VAS)

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 12 months

Other outcomes

  1. Decrease in Numerical Rating Scale

    Time frame: 12 months

  2. Decrease in Functional Rating Index

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

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

Acronym: RFNaTDD

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 1, 2014
Registry last updated
Jan 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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