Clinical trial NCT04786145: Cryoneurolysis Outcome on Pain Experience (COPE) in Patients With Low-back Pain
Official title: Cryoneurolysis Outcome on Pain Experience (COPE) in Patients With Low-back Pain - a Single-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low-back Pain
Facet Joint Pain
Degeneration Lumbar Spine
Facet Joint Syndrome
Back Pain Lower Back Chronic
Keywords: low-back pain
cryoneurolysis on lower-back pain
Cryoanalgesia
Cryoneurolysis
Cryoneuroablation
Radiofrequency ablation.
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2021-03-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a single-center, blinded randomized controlled trial with two intervention arms and one placebo arm with allocation ratio of 1:1:1. One group receives one treatment of cryoneurolysis, the second group receives radiofrequency ablation and the third group receives placebo (control group).
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: The effect of the intervention, assessed by Patient Global Impression of Change (PGIC) at 4 weeks follow-up
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Patient Global Impression of Change (PGIC) at day one, three, six and 12 months follow-up.
timeFrame: 1-12 months
measure: Change in the Numeric Rating Scale (NRS-11) from baseline to day one, four weeks, three, six and 12 months follow-up
timeFrame: 1-12 months
measure: Change in the Pain Catastrophizing Scale (PCS) at baseline, four weeks, three, six and 12 months follow-up
timeFrame: 1-12 months
measure: Change from baseline to six and 12 months follow-up in the Oswestry Disability Index (ODI).
timeFrame: 1-12 months
measure: Change from baseline to six and 12 months follow-up in the European Quality of Life - 5 Dimensions (EQ5D)
timeFrame: 1-12 months
measure: Change from baseline to 12 months follow-up for change in Major Depression Inventory (MDI) and the Short Form (36) Health Survey (SF-36)
timeFrame: 1-12 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Neurosurgery, Aarhus University Hospital
state: Central Denmark
Study officials:
affiliation: University of Aarhus
name: Kaare Meier, MD, Ph.D
role: STUDY_DIRECTOR
affiliation: University of Aarhus
name: Lone Nikolajsen, M.D, Prof.
role: STUDY_DIRECTOR
affiliation: University of Aarhus
name: Maurits Van Tulder, Prof.
role: STUDY_DIRECTOR
affiliation: University of Aarhus
name: Jens Christian H Sørensen, M.D, Prof.
role: STUDY_DIRECTOR
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