An observational study in Visual Analogue Pain Scale and Pain Measurement, sponsored by Ankara University. Completed at 1 site in Turkey. Open to participants aged 35 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-01-01.
Sponsored by Ankara University · Observational
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.
488 studies on the registry are indexed under Radiculopathy; 141 are open to participants now.
This study's enrollment of 73 is below the median of 93 across 98 observational studies indexed under Radiculopathy.
Browse Radiculopathy studies →Ankara University is the lead sponsor of 312 studies on the registry; 68 are open to participants now.
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120 patients with lumbar radiculopathy undergoing nucleoplasty and targetted disc decompression in Algology Department of a University Hospital between 2010 and 2012 were retrospectively evaluated and complete data of only 73 patients were reached and they were included to the study
Exclusion Criteria:
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 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 \[ArthroCare Spine, Sunnyvale, CA\]
Also known as: ArthroCare Spine, SpineCATH®
Decrease in Visual Analogue Scale (VAS)
Time frame: 12 months
More than 50% procedure-related patient satisfaction ratio in North American Spine Society Satisfaction Scale
Time frame: 12 months
Decrease in Numerical Rating Scale
Time frame: 12 months
Decrease in Functional Rating Index
Time frame: 12 months
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Ankara University