Efficacy of Radiofrequency Nucleoplasty and Targeted Disc Decompression in Lumbar Radiculopathy

Study Overview
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Brief Summary
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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.

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

Conditions
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Visual Analogue Pain Scale, Pain Measurement

Intervention / Treatment
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* Procedure: Group Decompression or Group Nucleoplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group Decompression<br>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<br>* 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]<br>* Other names: SpineCATH®;|
| Group Nucleoplasty<br>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<br>* 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]<br>* Other names: SpineCATH®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Visual Analogue Scale (VAS) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| More than 50% procedure-related patient satisfaction ratio in North American Spine Society Satisfaction Scale |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intervertebral disc disease, Radiculopathy, Chronic pain, Thermocoagulation