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

Chronic Low-back Pain Clinical Trial

— COPE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04786145
• Other study ID #: COPE
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 15, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: January 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthralgia
• Back Pain
• Back Pain Lower Back Chronic
• Chronic Low-back Pain
• Degeneration Lumbar Spine
• Facet Joint Pain
• Facet Joint Syndrome
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Department of Neurosurgery, Aarhus University Hospital	Aarhus	Central Denmark

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. Epub 2006 Aug 23. — View Citation

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. — View Citation

Cohen SP, Raja SN. Pathogenesis, diagnosis, and treatment of lumbar zygapophysial (facet) joint pain. Anesthesiology. 2007 Mar;106(3):591-614. Review. — View Citation

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

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. — View Citation

Freynhagen R, Baron R, Gockel U, Tölle 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2014 Jul 28. Review. — View Citation

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;(10):CD008572. doi: 10.1002/14651858.CD008572.pub2. Review. — View Citation

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 Mar;66(3). pii: A5533. — View Citation

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 Jul;23(6):1117-1128. doi: 10.1002/ejp.1378. Epub 2019 Mar 18. — View Citation

Schmidt CO, Schweikert B, Wenig CM, Schmidt U, Gockel U, Freynhagen R, Tölle 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. — View Citation

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

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

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1-12 months
Secondary	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.	1-12 months
Secondary	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.	1-12 months
Secondary	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.	1-12 months
Secondary	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.	1-12 months
Secondary	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.	1-12 months