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

NCT04786145 | Unknown DMC

• 1 other identifier: COPE
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

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.

Outcome Measures

Primary Outcomes (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

  4 weeks

Secondary Outcomes (6)

• Change in Patient Global Impression of Change (PGIC) at day one, three, six and 12 months follow-up.

  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

  1-12 months

• Change in the Pain Catastrophizing Scale (PCS) at baseline, four weeks, three, six and 12 months follow-up

  1-12 months

• Change from baseline to six and 12 months follow-up in the Oswestry Disability Index (ODI).

  1-12 months

• Change from baseline to six and 12 months follow-up in the European Quality of Life - 5 Dimensions (EQ5D)

  1-12 months

Study Arms (3)

Cryoneurolysis

ACTIVE COMPARATOR

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

Radiofrequency ablation

ACTIVE COMPARATOR

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

Placebo

SHAM COMPARATOR

40 patients are randomized to receive sham treatment. Subjected to similar procedures as cryoneurolysis and radiofrequency ablation, but without active treatment.

Procedure: Placebo

Interventions

Cryoneurolysis PROCEDURE

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.

Also known as: cryoanalgesia, cryoneuroablation

Cryoneurolysis

Radiofrequency ablation PROCEDURE

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.

Radiofrequency ablation

Placebo PROCEDURE

No active treatment is given.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Department of Neurosurgery, Aarhus University Hospital

Aarhus, Central Denmark, 8200, Denmark

Location

Related Publications (20)

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  BACKGROUND

• 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.

  PMID: 19468914 BACKGROUND

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

  PMID: 16880882 BACKGROUND

• 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.

  PMID: 17022849 BACKGROUND

• 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.

  PMID: 19201230 BACKGROUND

• 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.

  PMID: 17325518 BACKGROUND

• 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.

  PMID: 21359539 BACKGROUND

• 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.

  PMID: 16927087 BACKGROUND

• 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.

  PMID: 26401741 BACKGROUND

• 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.

  PMID: 17196489 BACKGROUND

• 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.

  PMID: 26495910 BACKGROUND

• 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.

  PMID: 29220124 BACKGROUND

• 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.

  PMID: 28576500 BACKGROUND

• 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.

  PMID: 25068973 BACKGROUND

• 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.

  PMID: 11690728 BACKGROUND

• Paulsen RT, Carreon L, Busch F, Isenberg-Jorgensen A. A pilot cohort study of lumbar facet joint denervation in patients with chronic low-back pain. Dan Med J. 2019 Mar;66(3):A5533.

  PMID: 30864544 BACKGROUND

• Perrot S, Lanteri-Minet M. Patients' Global Impression of Change in the management of peripheral neuropathic pain: Clinical relevance and correlations in daily practice. Eur J Pain. 2019 Jul;23(6):1117-1128. doi: 10.1002/ejp.1378. Epub 2019 Mar 18.

  PMID: 30793414 BACKGROUND

• Correll DJ. The Measurement of Pain: Objectifying the Subjective. Pain Management volume 1, 2007, Pages 197-211

  BACKGROUND

• Truong K, Meier K, Ahrens LC, Wichmann TO, Zaer H, Tiroke LH, Arvin S, Bazys M, Duel P, Gudmundsdottir G, Carlsen JG, Nikolajsen L, van Tulder M, Sorensen JCH, Rasmussen MM. Cryoneurolysis versus radiofrequency ablation outcome on pain experience in chronic low back pain (COPE): a single-blinded randomised controlled trial. RMD Open. 2024 May 9;10(2):e004196. doi: 10.1136/rmdopen-2024-004196.

  PMID: 38724261 DERIVED

• Truong K, Meier K, Nikolajsen L, van Tulder MW, Sorensen JCH, Rasmussen MM. Cryoneurolysis' outcome on pain experience (COPE) in patients with low-back pain: study protocol for a single-blinded randomized controlled trial. BMC Musculoskelet Disord. 2021 May 19;22(1):458. doi: 10.1186/s12891-021-04320-7.

  PMID: 34011351 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessors, physiotherapists and participants are blinded to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 8, 2021
• Study Start: February 15, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)