Cryoneurolysis' outcome on pain experience (COPE) in patients with low-back pain: study protocol for a single-blinded randomized controlled trial

K Truong, K Meier, L Nikolajsen, M W van Tulder, J C H Sørensen, M M Rasmussen, K Truong, K Meier, L Nikolajsen, M W van Tulder, J C H Sørensen, M M Rasmussen

Abstract

Background: Low-back pain, including facet joint pain, accounts for up to 20 % of all sick leaves in DenmarkA 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 the patients' impression of change in pain after intervention (Patient Global Impression of Change (PGIC)) at 4 weeks follow-up, prior to physiotherapy. Secondary outcomes are a reduction in low-back pain intensity (numeric rating scale) and 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 (T6).

Discussion: This study will provide information on the effectiveness of cryoneurolysis vs. the effectiveness of radiofrequency ablation or placebo for patients with facet joint pain, and help to establish whether cryoneurolysis should be implemented in clinical practice for this patient population.

Trial registration: The trial is approved by the ethical committee of Central Jutland Denmark with registration number 1-10-72-27-19 and the Danish Data Protection Agency with registration number 666,852. The study is registered at Clinicaltrial.gov with the ID number NCT04786145 .

Keywords: Cryoanalgesia; Cryoneuroablation; Cryoneurolysis; Cryoneurolysis on lower-back pain; Low-back pain; Radiofrequency ablation.

Conflict of interest statement

The authors declare that they have no interest of conflict.

Figures

Fig. 1
Fig. 1
X-ray (anterior posterior view) on the right shows the cannulaplacements when performing intervention on the lumbar spine. The x-ray on theleft shows the medial branch nerves marked with yellow and the cannulaplacement marked with blue dots
Fig. 2
Fig. 2
Flowchart of the enrollment process
Fig. 3
Fig. 3
Randomization and data collection; Time 0-6 (T0-6)

References

    1. Sundhedsstyrelsen. Anbefalinger for tværsektorielle forløb for mennesker med kroniske lænderygsmerter. 2017;1(1.1):1–38.
    1. Binder DS, Nampiaparampil DE. The provocative lumbar facet joint. Curr Rev Musculoskelet Med. 2009 Mar;2(1):15–24.
    1. Trescot AM. Cryoanalgesia in interventional pain management. Pain Physician. 2003;6(3):345–60. doi: 10.36076/ppj.2003/6/345.
    1. 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;22(10):1911–20. doi: 10.1185/030079906X132488.
    1. Schmidt CO, Schweikert B, Wenig CM, et al. Modelling the prevalence and cost of back pain with neuropathic components in the general population. Eur J Pain. 2009;13(10):1030–5. doi: 10.1016/j.ejpain.2008.12.003.
    1. Cohen SP, Raja NS. Pathogenesis, Diagnosis, and Treatment of Lumbar Zygapophysial (Facet) Joint Pain. Anesthesiology. 2007;106:591–614. doi: 10.1097/00000542-200703000-00024.
    1. 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;153(5):1011–9. doi: 10.1007/s00701-011-0966-9.
    1. Birkenmaier C, Veihelmann A, Trouillier H, Hausdorf J, Devens C, Wegener B, et al. Percutaneous cryodenervation of lumbar facet joints: a prospective clinical trial. Int Orthop. 2007;31(4):525–30. doi: 10.1007/s00264-006-0208-6.
    1. 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.
    1. 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;32(1):27–33.
    1. Maas ET, Ostelo RW, Niemisto L, Jousimaa J, Hurri H, Malmivaara A, et al. Radiofrequency denervation for chronic low back pain. Cochrane Database Syst Rev 2015;(10):CD008572.
    1. Juch JNS, Maas ET, Ostelo RWJG, Groeneweg JG, Kallewaard JW, Koes BW, 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.
    1. 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;17(11):1770–1780.
    1. Leggett LE, Soril LJ, Lorenzetti DL, Noseworthy T, Steadman R, Tiwana S, et al. Radiofrequency ablation for chronic low back pain: a systematic review of randomized controlled trials. Pain Res Manag 2014;19(5):e146-53.
    1. Farrar JT, Young JP, Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94:149–58. doi: 10.1016/S0304-3959(01)00349-9.
    1. Correll DJ. The Measurement of Pain: Objectifying the Subjective. Pain Manag. 2007;1:197–211. doi: 10.1016/B978-0-7216-0334-6.50022-4.
    1. Hempel S, Maggard-Gibbons M, Nguyen DK, et al. Wrong-Site Surgery, Retained Surgical Items, and Surgical Fires: A Systematic Review of Surgical Never Events. JAMA Surg. 2015;150(8):796–805. doi: 10.1001/jamasurg.2015.0301.
    1. Paulsen RT, Carreon L, Busch F, Isenberg-Jørgensen A. A pilot cohort study of lumbar facet joint denervation in patients with chronic low-back pain. Dan Med J. 2019;66(3):A5533. PMID: 30864544.
    1. Perrot S, Lantéri-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;23(6):1117–28. doi: 10.1002/ejp.1378.
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81. doi: 10.1016/j.jbi.2008.08.010.
    1. van Belle G, Fisher LD, Heagerty PJ, Lumley T. Biostatistics: A Methodology for the Health Sciences. 2nd Edition: Chap. 1 Longitudinal Data Analysis. 2002.
    1. Mishra P, Singh U, Pandey CM, Mishra P, Pandey G. Application of Student’s t-test, Analysis of Variance, and Covariance. Ann Card Anaesth. 2019;22(4):407–11. doi: 10.4103/aca.ACA_94_19.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir