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Cryoneurolysis Outcome on Pain Experience (COPE) in Patients With Low-back Pain

NCT04786145 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-08-25

No results posted yet for this study

Summary

This study will provide information on the effectiveness of cryoneurolysis for patients with facet joint pain syndrome, and help to establish whether cryoneurolysis should be implemented in clinical practice for this patient population.

Conditions

  • Chronic Low-back Pain
  • Facet Joint Pain
  • Degeneration Lumbar Spine
  • Facet Joint Syndrome
  • Back Pain Lower Back Chronic

Interventions

PROCEDURE

Cryoneurolysis

This is a medical procedure that temporarily blocks nerve conduction along peripheral nerve pathways by freezing it. Small probe is inserted in order to freeze the target nerve, can facilitate complete regeneration of the structure and function of the affected nerve.

PROCEDURE

Radiofrequency ablation

This is a medical procedure that temporarily blocks nerve conduction along peripheral nerve pathways. Small needle with an active heating tip is inserted, to destroy the functionality of the target nerve using heat from radiofrequency energy.

PROCEDURE

Placebo

No active treatment is given.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Kaare Meier, MD, Ph.D · University of Aarhus

  • Lone Nikolajsen, M.D, Prof. · University of Aarhus

  • Maurits Van Tulder, Prof. · University of Aarhus

  • Jens Christian H Sørensen, M.D, Prof. · University of Aarhus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-15
Primary Completion
2022-10-01
Completion
2022-10-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04786145 on ClinicalTrials.gov