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

Study Overview
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Brief Summary
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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
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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

Official Title
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Cryoneurolysis Outcome on Pain Experience (COPE) in Patients With Low-back Pain - a Single-blinded Randomized Controlled Trial

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

Intervention / Treatment
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* Procedure: Cryoneurolysis
* Procedure: Radiofrequency ablation
* Procedure: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cryoneurolysis<br>40 patients are randomized to receive one treatment of cryoneurolysis on the facet joints of three lumbar level corresponding to their facet joint pain generator | Procedure: Cryoneurolysis<br>* 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.<br>* Other names: cryoneuroablation;|
| Active Comparator: Radiofrequency ablation<br>40 patients are randomized to receive one treatment of radiofrequency ablation on the facet joints of three lumbar level corresponding to their facet joint pain generator | Procedure: Radiofrequency ablation<br>* 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.<br>|
| Sham Comparator: Placebo<br>40 patients are randomized to receive sham treatment. Subjected to similar procedures as cryoneurolysis and radiofrequency ablation, but without active treatment. | Procedure: Placebo<br>* No active treatment is given.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of the intervention, assessed by Patient Global Impression of Change (PGIC) at 4 weeks follow-up | The Patient Global Impression of Change (PGIC) is a 7-point patient self-reporting scale of overall improvement after treatment ranging from 1) very much improved, 2) much improved, 3) minimally improved, 4) no change, 5) minimally worse, 6) much worse, or 7) very much worse | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Global Impression of Change (PGIC) at day one, three, six and 12 months follow-up. | The Patient Global Impression of Change (PGIC) is a 7-point patient self-reporting scale of overall improvement after treatment ranging from 1) very much improved, 2) much improved, 3) minimally improved, 4) no change, 5) minimally worse, 6) much worse, or 7) very much worse. | 1-12 months | 
| Change in the Numeric Rating Scale (NRS-11) from baseline to day one, four weeks, three, six and 12 months follow-up | The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain from 0 no pain to 10 worst pain imaginable. | 1-12 months | 
| Change in the Pain Catastrophizing Scale (PCS) at baseline, four weeks, three, six and 12 months follow-up | The Pain Catastrophizing Scale (PCS) assesses the extent of catastrophic thinking due to low back pain according to 3 components: rumination, magnification, and helplessness. It is a self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52. The higher the score, the more catastrophizing thoughts are present. | 1-12 months | 
| Change from baseline to six and 12 months follow-up in the Oswestry Disability Index (ODI). | The Owestry Disability Index (ODI) comprises 10 sections with 5 questions in each to measure a patient's permanent functional disability. For each section the scores range of 0 to 5, resulting in a total possible score of 50. If all 10 sections are completed the score is calculated as follows: if 16 (total scored) out of 50 (total possible score) x 100 = 32%. The higher the calculated percentage, the more severe the disability is. | 1-12 months | 
| Change from baseline to six and 12 months follow-up in the European Quality of Life - 5 Dimensions (EQ5D) | The European Quality of Life - 5 Dimensions (EQ5D) comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem. A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, in each dimension, where higher scores indicate more severe. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health status. | 1-12 months | 
| Change from baseline to 12 months follow-up for change in Major Depression Inventory (MDI) and the Short Form (36) Health Survey (SF-36) | The Major Depression Inventory (MDI) is a self-reporting measure to assess the presence and severity of a depressive disorder. It consists of 10 questions with a total possible score of 50. A score of under 20 indicates no depression and a score of more than 29 indicates severe depression. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. it consists of 8 scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability while higher scores indicate the less disability .The maximum score of 100 indicates the best possible health state. | 1-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low-back pain, cryoneurolysis on lower-back pain, Cryoanalgesia, Cryoneurolysis, Cryoneuroablation, Radiofrequency ablation.