Status:
UNKNOWN
Cryoneurolysis Outcome on Pain Experience (COPE) in Patients With Low-back Pain
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital
Conditions:
Chronic Low-back Pain
Facet Joint Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 p...
Detailed Description
Background: Low-back pain, including facet joint pain, accounts for up to 20 percent of all sick leaves in Denmark; among these are patients with facet joint pain syndrome. A proposed treatment option...
Eligibility Criteria
Inclusion
- Low-back pain from facet joint syndrom (facet joint pain) \> 3 months' duration with or without neuropathic pain component.
- Low-back pain on Numeric Rating Scale ≥ 4
Exclusion
- Presence of nerve root or spinal canal compression; signs of inflammatory or erosive processes in the spine verified on magnetic resonance imaging (MRI).
- Neurological deficits i.e. symptoms of nerve root compression; tingling, numbness, weakness/ paresis, and reflex loss in the lower extremities.
- Major co-morbidity.
- Anti-thrombotic or anti-platelet treatment which cannot be paused for a week.
- Active malignancies.
- Chronic inflammatory disease.
- Known severe psychiatric disease. Patients with mild and well-treated depression and anxiety are not excluded.
Key Trial Info
Start Date :
February 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04786145
Start Date
February 15 2020
End Date
October 1 2022
Last Update
August 25 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Neurosurgery, Aarhus University Hospital
Aarhus, Central Denmark, Denmark, 8200