Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04786145
Status:
UNKNOWN
Last Update Posted:
2022-08-25
First Post:
2021-03-03
Brief Title:
Cryoneurolysis Outcome on Pain Experience COPE in Patients With Low-back Pain
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Cryoneurolysis Outcome on Pain Experience COPE in Patients With Low-back Pain - a Single-blinded Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPE
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 practice for this patient population
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 is cryoneurolysis This study aims to investigate the effect of cryoneurolysis in lumbar facet joint pain syndrome
Methods A single-center randomized controlled trial RCT is performed including 120 participants with chronic facet joint pain syndrome referred to the Department of Neurosurgery Aarhus University Hospital Eligible patients receive a diagnostic anesthetic block where a reduction of pain intensity 50 on a numerical rating scale NRS is required to be enrolled Participants are randomized into three groups to undergo either one treatment of cryoneurolysis radiofrequency ablation or placebo Fluoroscopy and sensory stimulation is used to identify the intended target nerve prior to administrating the above-mentioned treatments All groups receive physiotherapy for 6 weeks starting 4 weeks after treatment The primary outcome is a reduction in low-back pain intensity and an impression of change in pain after intervention Patient Global Impression of Change PGIC at 4 weeks follow-up prior to physiotherapy Secondary outcomes are quality of life EQ-5D SF-36 and level of function Oswestry Disability Index psychological perception of pain Pain Catastrophizing Scale and depression status Major Depression Inventory Data will be assessed at baseline T0 randomization T1 day one T2 4 weeks T3 3 T4 6 T5 and 12 months
Methods A single-center randomized controlled trial RCT is performed including 120 participants with chronic facet joint pain syndrome referred to the Department of Neurosurgery Aarhus University Hospital Eligible patients receive a diagnostic anesthetic block where a reduction of pain intensity 50 on a numerical rating scale NRS is required to be enrolled Participants are randomized into three groups to undergo either one treatment of cryoneurolysis radiofrequency ablation or placebo Fluoroscopy and sensory stimulation is used to identify the intended target nerve prior to administrating the above-mentioned treatments All groups receive physiotherapy for 6 weeks starting 4 weeks after treatment The primary outcome is a reduction in low-back pain intensity and an impression of change in pain after intervention Patient Global Impression of Change PGIC at 4 weeks follow-up prior to physiotherapy Secondary outcomes are quality of life EQ-5D SF-36 and level of function Oswestry Disability Index psychological perception of pain Pain Catastrophizing Scale and depression status Major Depression Inventory Data will be assessed at baseline T0 randomization T1 day one T2 4 weeks T3 3 T4 6 T5 and 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None