NCT04684303

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

December 15, 2020

Last Update Submit

December 29, 2020

Conditions

Back Pain

Outcome Measures

Primary Outcomes (6)

  • Change from baseline EuroQoL-5 dimension (EQ-5D) value 6m

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

    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

    12 months follow-up

  • Change from baseline Visual Analog Pain Scale (VAS) of back pain 6m

    VAS 10 point measurement

    6 months follow-up

  • Change from baseline Visual Analog Pain Scale (VAS) of back pain 12m

    VAS 10 point measurement

    12 months follow-up

  • Oswestry disability index (ODI) 6m

    The ODI self-administered questionnaire measuring 0-100 scale

    6 months follow-up

  • Oswestry disability index (ODI) 12m

    The ODI self-administered questionnaire measuring 0-100 scale

    12 months follow-up

Secondary Outcomes (4)

  • Before procedure drug usage

    before procedure

  • Postprocedural drug usage

    12 months follow-up

  • Appearance and rate of complications related to procedure

    12 months follow-up

  • Dose of radiation exposure

    12 months follow-up

Study Arms (2)

Lumbar medial branch RF neurotomy

EXPERIMENTAL

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

Procedure: Lumbar medial branch radiofrequency ablation neurotomy

Lumbar medial branch cryoablation

EXPERIMENTAL

Procedure lumbar medial branch cryoablation Decreasing the temperature of the electrode to - 85 C for 120 seconds in two cycles. Follow-up: before procedure, 3 months, 6 months, 12 months and 24 months after procedure Repeated cryoablation ablation procedures is allowed (when VAS will be =/\> 4 )

Procedure: Lumbar medial branch cryo ablation neurotomy

Interventions

Lumbar medial branch radiofrequency ablation neurotomyPROCEDURE

Procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy

Lumbar medial branch RF neurotomy
Lumbar medial branch cryo ablation neurotomyPROCEDURE

Procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy

Lumbar medial branch cryoablation

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients aged between 20 and 80
  • positive two medial branch nerve blocks with pain relief over 80% during the first 12hours after nerve block application
  • positive patient history for 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

You may not qualify if:

  • patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
  • women with positive a pregnancy test 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EuroPainClinics

Bardejov, 085 01, Slovakia

RECRUITING

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ladislav Kocan, MD PhD

CONTACT

+421557891110europainclinicsstudy@gmail.com

Robert Rapcan, MD PhD FIPP

CONTACT

rapcan@europainclinics.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective observational clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2020

First Posted

December 24, 2020

Study Start

January 1, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

December 30, 2020

Record last verified: 2020-12

Locations

SL(1)