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Chronic Low-back PainCOPENCT04786145

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

A study testing Cryoneurolysis and Radiofrequency ablation in people with Chronic Low-back Pain and Facet Joint Pain, run by University of Aarhus at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Cryoneurolysis and Radiofrequency ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteDenmark
Study dates
15 Feb 2020to 1 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Neurosurgery, Aarhus University Hospital

    Aarhus, Central Denmark, 8200

Other trials in Denmark

About this study

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

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.

Read the 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

Being tested
Cryoneurolysis, Radiofrequency ablation, Placebo
Keywords
low-back pain, cryoneurolysis on lower-back pain, Cryoanalgesia, Cryoneurolysis, Cryoneuroablation, Radiofrequency ablation.
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CryoneurolysisProcedure or surgery

    Also called cryoanalgesia, cryoneuroablation

    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.

  • Radiofrequency ablationProcedure or surgery

    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.

  • PlaceboProcedure or surgery

    No active treatment is given.

Study groups in NCT04786145
Study groupRoleWhat they receive
CryoneurolysisActive comparator40 patients are randomized to receive one treatment of cryoneurolysis on the facet joints of three lumbar level corresponding to their facet joint pain generator
Receives: Procedure: Cryoneurolysis
Radiofrequency ablationActive comparator40 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
Receives: Procedure: Radiofrequency ablation
PlaceboSham comparator40 patients are randomized to receive sham treatment. Subjected to similar procedures as cryoneurolysis and radiofrequency ablation, but without active treatment.
Receives: Procedure: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 4 weeks

Secondary outcomes (6)

  1. 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.

    Measured: 1-12 months

  2. 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.

    Measured: 1-12 months

  3. 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.

    Measured: 1-12 months

  4. 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.

    Measured: 1-12 months

  5. 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.

    Measured: 1-12 months

  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)

    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.

    Measured: 1-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2021
  2. Study start15 Feb 2020
  3. Primary completion1 Oct 2022 (estimated)
  4. Study completion1 Oct 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04786145
Sponsor's protocol ID
COPE
Acronym
COPE
Status last verified
Jan 2022
First submitted
3 Mar 2021
Last updated
25 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sundhedsstyrelsen. Anbefalinger for tværsektorielle forløb for mennesker med kroniske lænderygsmerter. 2017 Pdf;1(1.1):1-38.

  • Binder DS, Nampiaparampil DE. The provocative lumbar facet joint. Curr Rev Musculoskelet Med. 2009 Mar;2(1):15-24. doi: 10.1007/s12178-008-9039-y. Epub 2009 Mar 31.

    PubMed 19468914

  • Trescot AM. Cryoanalgesia in interventional pain management. Pain Physician. 2003 Jul;6(3):345-60.

    PubMed 16880882

  • Freynhagen R, Baron R, Gockel U, Tolle TR. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin. 2006 Oct;22(10):1911-20. doi: 10.1185/030079906X132488.

    PubMed 17022849

  • Schmidt CO, Schweikert B, Wenig CM, Schmidt U, Gockel U, Freynhagen R, Tolle TR, Baron R, Kohlmann T. Modelling the prevalence and cost of back pain with neuropathic components in the general population. Eur J Pain. 2009 Nov;13(10):1030-5. doi: 10.1016/j.ejpain.2008.12.003. Epub 2009 Feb 6.

    PubMed 19201230

  • Cohen SP, Raja SN. Pathogenesis, diagnosis, and treatment of lumbar zygapophysial (facet) joint pain. Anesthesiology. 2007 Mar;106(3):591-614. doi: 10.1097/00000542-200703000-00024.

    PubMed 17325518

  • Wolter T, Deininger M, Hubbe U, Mohadjer M, Knoeller S. Cryoneurolysis for zygapophyseal joint pain: a retrospective analysis of 117 interventions. Acta Neurochir (Wien). 2011 May;153(5):1011-9. doi: 10.1007/s00701-011-0966-9. Epub 2011 Feb 26.

    PubMed 21359539

  • Birkenmaier C, Veihelmann A, Trouillier H, Hausdorf J, Devens C, Wegener B, Jansson V, von Schulze Pellengahr C. Percutaneous cryodenervation of lumbar facet joints: a prospective clinical trial. Int Orthop. 2007 Aug;31(4):525-30. doi: 10.1007/s00264-006-0208-6. Epub 2006 Aug 23.

    PubMed 16927087

  • Bellini M, Barbieri M. Percutaneous cryoanalgesia in pain management: a case-series. Anaesthesiol Intensive Ther. 2015;47(4):333-5. doi: 10.5603/AIT.2015.0045.

    PubMed 26401741

  • Birkenmaier C, Veihelmann A, Trouillier HH, Hausdorf J, von Schulze Pellengahr C. Medial branch blocks versus pericapsular blocks in selecting patients for percutaneous cryodenervation of lumbar facet joints. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):27-33. doi: 10.1016/j.rapm.2006.08.014.

    PubMed 17196489

  • Maas ET, Ostelo RW, Niemisto L, Jousimaa J, Hurri H, Malmivaara A, van Tulder MW. Radiofrequency denervation for chronic low back pain. Cochrane Database Syst Rev. 2015 Oct 23;2015(10):CD008572. doi: 10.1002/14651858.CD008572.pub2.

    PubMed 26495910

  • Kapural L, Provenzano D, Narouze S. RE: Juch JNS, et al. Effect of Radiofrequency Denervation on Pain Intensity Among Patients With Chronic Low Back Pain: The Mint Randomized Clinical Trials. JAMA 2017;318(1):68-81. Neuromodulation. 2017 Dec;20(8):844. doi: 10.1111/ner.12729. No abstract available.

    PubMed 29220124

  • Lee CH, Chung CK, Kim CH. The efficacy of conventional radiofrequency denervation in patients with chronic low back pain originating from the facet joints: a meta-analysis of randomized controlled trials. Spine J. 2017 Nov;17(11):1770-1780. doi: 10.1016/j.spinee.2017.05.006. Epub 2017 May 30.

    PubMed 28576500

  • Leggett LE, Soril LJ, Lorenzetti DL, Noseworthy T, Steadman R, Tiwana S, Clement F. Radiofrequency ablation for chronic low back pain: a systematic review of randomized controlled trials. Pain Res Manag. 2014 Sep-Oct;19(5):e146-53. doi: 10.1155/2014/834369. Epub 2014 Jul 28.

    PubMed 25068973

  • Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.

    PubMed 11690728

Questions about this trial

What is this clinical trial studying?

A study testing Cryoneurolysis and Radiofrequency ablation in people with Chronic Low-back Pain and Facet Joint Pain, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The effect of the intervention, assessed by Patient Global Impression of Change (PGIC) at 4 weeks follow-up (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04786145, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.

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