CLINICAL TRIAL
JOURNAL ARTICLE
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The results of nucleoplasty in patients with lumbar herniated disc: a prospective clinical study of 52 consecutive patients.

BACKGROUND CONTEXT: Nucleoplasty is a minimally invasive, percutaneous procedure that uses radiofrequency energy to ablate nuclear material and create small channels within the disc.

PURPOSE: To evaluate the efficacy of nucleoplasty technique in patients with leg pain caused by radicular encroachment.

STUDY DESIGN/SETTING: A prospective clinical study of subjects with lumbar disc herniation, and radicular pain resistant to previous medical treatment and physiotherapy for a period of at least 3 months.

PATIENT SAMPLE: Fifty-two consecutive patients with leg pain and magnetic resonance imaging evidence of small and medium-sized herniated discs correlating with the patient's symptoms (contained disc herniation<6 mm, with a disc height>/=50% in comparison to normal adjacent discs) were included.

OUTCOME MEASURES: Visual analogue scale (VAS) was administered and Oswestry disability questionnaires were filled out at preprocedure and postprocedure 2 weeks, 6 months, and 1 year. Reduction of analgesic treatment and the patients' satisfaction were also recorded.

METHODS: All procedures were performed under local anesthesia and fluoroscopic guidance on an outpatient basis. Patients underwent discography to evaluate annular integrity just before nucleoplasty. Channels were created in the nucleus by advancing the radiofrequency probe (ablating) and withdrawing it (coagulation). In all patients six channels were created.

RESULTS: Thirty-four patients had one and 18 had two discs treated; a total of 70 procedures were performed. Mean age of patients was 44.8+/-8.6 years. The mean follow-up period was 12.1+/-1.6 months. Mean VAS reduced from preprocedure 7.5 to 3.1 at postprocedure 6 months and to 2.1 at the latest follow-up. Mean Oswestry index decreased from 42.2 to 24.8 at 6 months and to 20.5 at the latest examination. Analgesic consumption was stopped or reduced in 42 patients (85%) at 6 months and in 46 patients (94%) 1 year after the procedure. Overall patient satisfaction was 81% at 2 weeks, 85% at 6 months, and 88% at the latest follow-up. There were no complications related to the procedures.

CONCLUSIONS: Our results encourage us to use nucleoplasty in carefully selected patients with leg pain caused by radicular encroachment. We recommend applying this minimally invasive technique only in those patients with small (<6 mm) contained disc herniations, with a disc height of>or=50% and with annular integrity.

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