Cryoneurolysis Outcome on Pain Experience (COPE) in Patients With Low-back Pain
NCT ID: NCT04786145
Last Updated: 2022-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2020-02-15
2022-10-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
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.
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
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.
Placebo
40 patients are randomized to receive sham treatment. Subjected to similar procedures as cryoneurolysis and radiofrequency ablation, but without active treatment.
Placebo
No active treatment is given.
Interventions
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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.
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.
Placebo
No active treatment is given.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Low-back pain on Numeric Rating Scale ≥ 4
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Kaare Meier, MD, Ph.D
Role: STUDY_DIRECTOR
University of Aarhus
Lone Nikolajsen, M.D, Prof.
Role: STUDY_DIRECTOR
University of Aarhus
Maurits Van Tulder, Prof.
Role: STUDY_DIRECTOR
University of Aarhus
Jens Christian H Sørensen, M.D, Prof.
Role: STUDY_DIRECTOR
University of Aarhus
Locations
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Department of Neurosurgery, Aarhus University Hospital
Aarhus, Central Denmark, Denmark
Countries
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References
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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.
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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.
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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.
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.
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.
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.
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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.
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.
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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.
Correll DJ. The Measurement of Pain: Objectifying the Subjective. Pain Management volume 1, 2007, Pages 197-211
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.
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.
Other Identifiers
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COPE
Identifier Type: -
Identifier Source: org_study_id
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