EuroPainClinicsStudy XIr-Zj

NCT ID: NCT05813639

Last Updated: 2023-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-02

Study Completion Date

2024-07-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospectively randomized patients with positive facet joint syndrome
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers
sealed envelope, random software

Study Groups

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Lumbar medial branch cryoablation

Lumbar medial branch cryoablation Procedure lumbar medial branch cryoablation Decreasing the electrode temperature to - 85 C for 120 seconds in two cycles. Follow-up: before the procedure, 3 months, 6 months, 12 months, and 24 months after the procedure Repeated cryoablation ablation procedures are allowed (when VAS will be =/\> 4 ) Procedure/Surgery: Lumbar medial branch cryo ablation neurotomy A procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy

Group Type EXPERIMENTAL

Lumbar medial branch cryo ablation neurotomy

Intervention Type PROCEDURE

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

Lumbar medial branch RF neurotomy

Lumbar medial branch RF neurotomy Procedure lumbar medial branch RF neurotomy: Raising the temperature of the tip of the electrode to 85 C for 120 seconds. RF generator. Follow-up: before the procedure, 3 months, 6 months, 12 months, and 24 months after the procedure. Repeated cryoablation ablation procedures are allowed (when VAS will be \> 4 )

Group Type EXPERIMENTAL

Lumbar medial branch radiofrequency ablation neurotomy

Intervention Type PROCEDURE

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

Lumbar fazet joint decapsulation

Lumbar facet joint decapsulation through an endoscopic approach

Group Type EXPERIMENTAL

Endoscopic denervation of fazet joint

Intervention Type PROCEDURE

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

Interventions

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Lumbar medial branch cryo ablation neurotomy

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

Intervention Type PROCEDURE

Lumbar medial branch radiofrequency ablation neurotomy

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

Intervention Type PROCEDURE

Endoscopic denervation of fazet joint

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Slovak Academy of Sciences

OTHER_GOV

Sponsor Role collaborator

Europainclinics z.ú.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD, PhD, FIPP Rapcan, MD, FIPP

Role: STUDY_CHAIR

R-Clinic Bardejov, Slovakia, 085 01

Locations

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MD, PhD, FIPP Rapcan

Bardejov, , Slovakia

Site Status

Countries

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Slovakia

References

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Kocan L, Rapcan R, Mlaka J, Griger M, Poliak L, Lences P, Kovalicova L, Manik E, Sherdil N, Burianek M, Vaskova J. Comparative Effectiveness of Radiofrequency Ablation, Cryoablation, and Endoscopic Denervation for Lumbar Facet Pain: A Multicenter Trial. Spine (Phila Pa 1976). 2025 Oct 14. doi: 10.1097/BRS.0000000000005539. Online ahead of print.

Reference Type DERIVED
PMID: 41084911 (View on PubMed)

Other Identifiers

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6146/2022/ODDZ-25513

Identifier Type: -

Identifier Source: org_study_id

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