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

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ClinicalTrials.gov Identifier: NCT04786145
Recruitment Status : Recruiting
First Posted : March 8, 2021
Last Update Posted : March 10, 2021
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Facet Joint Pain Degeneration Lumbar Spine Facet Joint Syndrome Back Pain Lower Back Chronic Procedure: Cryoneurolysis Procedure: Radiofrequency ablation Procedure: Placebo Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Outcomes Assessors, physiotherapists and participants are blinded to the intervention.
Primary Purpose: Treatment
Official Title: Cryoneurolysis Outcome on Pain Experience (COPE) in Patients With Low-back Pain - a Single-blinded Randomized Controlled Trial
Actual Study Start Date : February 15, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Cryoneurolysis
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
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.
Other Names:
  • cryoanalgesia
  • cryoneuroablation

Active Comparator: Radiofrequency ablation
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
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.

Sham Comparator: Placebo
40 patients are randomized to receive sham treatment. Subjected to similar procedures as cryoneurolysis and radiofrequency ablation, but without active treatment.
Procedure: Placebo
No active treatment is given.




Primary Outcome Measures :
  1. The effect of the intervention, assessed by Patient Global Impression of Change (PGIC) at 4 weeks follow-up [ Time Frame: 4 weeks ]
    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


Secondary Outcome Measures :
  1. Change in Patient Global Impression of Change (PGIC) at day one, three, six and 12 months follow-up. [ Time Frame: 1-12 months ]
    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.

  2. Change in the Numeric Rating Scale (NRS-11) from baseline to day one, four weeks, three, six and 12 months follow-up [ Time Frame: 1-12 months ]
    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.

  3. Change in the Pain Catastrophizing Scale (PCS) at baseline, four weeks, three, six and 12 months follow-up [ Time Frame: 1-12 months ]

    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.


  4. Change from baseline to six and 12 months follow-up in the Oswestry Disability Index (ODI). [ Time Frame: 1-12 months ]
    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.

  5. Change from baseline to six and 12 months follow-up in the European Quality of Life - 5 Dimensions (EQ5D) [ Time Frame: 1-12 months ]
    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.

  6. Change from baseline to 12 months follow-up for change in Major Depression Inventory (MDI) and the Short Form (36) Health Survey (SF-36) [ Time Frame: 1-12 months ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04786145


Contacts
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Contact: Kamilla My Truong, M.D +4542321578 kamilla.truong@clin.au.dk
Contact: Mikkel M Rasmussen, MD, Ph.D mikkrasm@rm.dk

Locations
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Denmark
Department of Neurosurgery, Aarhus University Hospital Recruiting
Aarhus, Central Denmark, Denmark, 8200
Contact: kamilla My Truong, MD    +4542321578    kamilla.truong@clin.au.dk   
Contact: Mikkel M Mylius, MD, Ph.D.       mikkrasm@rm.dk   
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
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Study Director: Kaare Meier, MD, Ph.D University of Aarhus
Study Director: Lone Nikolajsen, M.D, Prof. University of Aarhus
Study Director: Maurits Van Tulder, Prof. University of Aarhus
Study Director: Jens Christian H Sørensen, M.D, Prof. University of Aarhus
Publications:
Sundhedsstyrelsen. Anbefalinger for tværsektorielle forløb for mennesker med kroniske lænderygsmerter. 2017 Pdf;1(1.1):1-38.
Correll DJ. The Measurement of Pain: Objectifying the Subjective. Pain Management volume 1, 2007, Pages 197-211

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04786145    
Other Study ID Numbers: COPE
First Posted: March 8, 2021    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
low-back pain
cryoneurolysis on lower-back pain
Cryoanalgesia
Cryoneurolysis
Cryoneuroablation
Radiofrequency ablation.
Additional relevant MeSH terms:
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Arthralgia
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Joint Diseases
Musculoskeletal Diseases