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

Ankara University

Status: Completed

Conditions: Visual Analogue Pain Scale; Pain Measurement

Treatments: Procedure: Group Decompression or Group Nucleoplasty

Study type: Observational

Funder types: Other

Identifiers

NCT02025283

10-402-13

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 35 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

73 participants in 2 patient groups

Group Decompression

Description:

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.

Treatment:

Procedure: Group Decompression or Group Nucleoplasty

Group Nucleoplasty

Description:

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.

Treatment:

Procedure: Group Decompression or Group Nucleoplasty