EuroPainClinicsStudy XIr-Zj

Europainclinics z.ú.150 enrolled

Overview

Determine the efficacy of lumbar medial branch neurotomy by radiofrequency and cryoablation in patients with chronic low back pain

Facet joint pain encompasses a significant portion of the possible sources of pain in patients with vertebrogenic algic syndrome.A typical symptom caused by facet joint irritation of the medial branch nerve is a back pain with intermittent irregular patchy pain spreading to the legs. The cause of this pain is irritation of the medial branch of the dorsal nerve root which innervates a facet joint. Confirmation of the source of the pain involves local anaesthetic blocks of the medial nerve branches in several adjoining vertebral areas. If this test is positive, then the patient's condition is indicated for radiofrequency ablation or cryoablation of the nerve branches. Description of interventional procedures: Patients with chronic low back pain with confirmed zygapophysial joint pain after previous two medial branch nerve blocks with positive results are indicated for radiofrequency medial neurotomy or alternative cryoablation neurotomy. Navigation with probes in both cases is arranged and directed according to fluoroscopic imaging.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Back Pain

Interventions

Lumbar medial branch cryo ablation neurotomyPROCEDURE

The procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy

Lumbar medial branch radiofrequency ablation neurotomyPROCEDURE

The procedure is based on positive lumbar Z- joint testing followed by medial branch neurotomy

Endoscopic denervation of fazet jointPROCEDURE

The procedure is based on positive lumbar Z- joint testing followed by decapsulation of the facet joint through an endoscopic approach

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients aged between 20 and 80 * positive two medial branch nerve blocks with pain relief over 80% during the first 12 hours after nerve block application * positive patient history of facet joint pain * patients with chronic low back pain for at least 6 months with back pain and leg pain (VAS \>=5) * those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form Exclusion Criteria: * patients with a history of other spinal diseases (compression fracture, spondylitis, tumor) * women with positive a pregnancy tests before the trial or who planned to become * pregnant within the following 3 years * other patients viewed as inappropriate by the staff * disagreement with participation in the study

Locations (1)

MD, PhD, FIPP Rapcan

Bardejov, Slovakia

Outcomes

Primary Outcomes

Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 6m

EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression

Time frame: 6 months follow-up

Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 12m

EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression

Time frame: 12 months follow-up

Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m

Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m measured by VAS 10 point measurement

Time frame: 6 months follow-up

Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m

Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m measured by VAS 10 point measurement

Time frame: 12 months follow-up

Oswestry Disability Index (ODI) 12m

The ODI self-administered questionnaire measuring 0-100 scale

Time frame: 12 months follow-up

Oswestry Disability Index (ODI) 6m

The ODI self-administered questionnaire measuring 0-100 scale

Time frame: 6 months follow-up

Data from ClinicalTrials.gov

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