Cryoneurolysis versus radiofrequency ablation outcome on pain experience in chronic low back pain (COPE): a single-blinded randomised controlled trial

Kamilla Truong; Kaare Meier; Lasse Cramer Ahrens; Thea Overgaard Wichmann; Hamed Zaer; Lasse Hubertus Tiroke; Simon Arvin; Mindaugas Bazys; Peter Duel; Gudrun Gudmundsdottir; Jakob Gram Carlsen; Lone Nikolajsen; Maurits van Tulder; Jens Christian Hedemann Sørensen; Mikkel Mylius Rasmussen

doi:10.1136/rmdopen-2024-004196

Cryoneurolysis versus radiofrequency ablation outcome on pain experience in chronic low back pain (COPE): a single-blinded randomised controlled trial

Kamilla Truong, Kaare Meier, Lasse Cramer Ahrens, Thea Overgaard Wichmann, Hamed Zaer, Lasse Hubertus Tiroke, Simon Arvin, Mindaugas Bazys, Peter Duel, Gudrun Gudmundsdottir, Jakob Gram Carlsen, Lone Nikolajsen, Maurits van Tulder, Jens Christian Hedemann Sørensen, Mikkel Mylius Rasmussen

Research output: Contribution to Journal › Article › Academic › peer-review

Abstract

OBJECTIVE: A comparison of cryoneurolysis or radio frequency (RF) with placebo in patients with facetogenic chronic low back pain (LBP) for patient global impression of change (PGIC), pain intensity, function and quality of life, with 1-year follow-up.

DESIGN: Single-centre, single-blinded placebo-controlled randomised controlled trial.

SETTING: Single-centre study.

PARTICIPANTS: Inclusion from March 2020 to September 2022: consenting adults over 18 years of age, LBP>3 months, average Numeric Rating Scale LBP≥4 average last 14 days and a positive response to a diagnostic medial branch block ( >50% pain reduction after 60 min).

INTERVENTIONS: 120 patients were block randomised 1:1:1 to cryoneurolysis, RF or placebo of the medial branch nerves. Physical therapy was added after 4 weeks for all groups.

MAIN OUTCOME MEASURES: Primary outcome was PGIC 4 weeks after the intervention. Secondary outcomes included pain intensity (Numeric Rating Scale, NRS), quality of life (Short Form 36, EQ-5D-5L), disability (Oswestry Disability Index), depression (Major Depression Inventory) and catastrophising (Pain Catastrophising Scale). Outcomes were measured at 4 weeks, 3, 6 and 12 months.

RESULTS: There was no statistically significant difference in PGIC at 4 weeks between cryoneurolysis and placebo (risk ratio (RR) 2; 95% CI 0.75 to 5.33, p=0.17) and RF and placebo (RR 1.6; 95% CI 0.57 to 4.49, p=0.37), except PGIC for cryoneurolysis at 6-month follow-up (RR 5.1; 95% CI 1.20 to 22.03, p=0.03). No statistically significant differences were found in secondary follow-up endpoints.

CONCLUSIONS: Denervation of the medial branch nerve by either cryoneurolysis or RF compared with placebo did not demonstrate significant improvement in PGIC, pain intensity, function and quality of life in patients with facetogenic chronic LBP at short-term or long-term follow-up.

TRIAL REGISTRATION NUMBER: NCT04786145.

Original language	English
Article number	e004196
Journal	RMD open
Volume	10
Issue number	2
DOIs	https://doi.org/10.1136/rmdopen-2024-004196
Publication status	Published - 9 May 2024

Bibliographical note

Funding

This study was funded by the Danish Health Authority social financing fund 'Satspuljen' with the grant number 4-1010-401-7 (7.3 mill. DKK). KT received a travel grant from the Knud H\u00F8jgaards foundation with the grant number 21-02-4298 (DKK12 000).

Funders	Funder number
Danish Health Authority social financing fund 'Satspuljen	4-1010-401-7
Knud Højgaards Fond	DKK12 000, 21-02-4298
Knud Højgaards Fond

Keywords

Humans
Low Back Pain/therapy
Male
Female
Middle Aged
Quality of Life
Radiofrequency Ablation/methods
Chronic Pain/therapy
Treatment Outcome
Pain Measurement
Adult
Single-Blind Method
Cryosurgery/methods
Aged
Pain Management/methods

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10.1136/rmdopen-2024-004196

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Truong, K., Meier, K., Ahrens, L. C., Wichmann, T. O., Zaer, H., Tiroke, L. H., Arvin, S., Bazys, M., Duel, P., Gudmundsdottir, G., Carlsen, J. G., Nikolajsen, L., van Tulder, M., Sørensen, J. C. H., & Rasmussen, M. M. (2024). Cryoneurolysis versus radiofrequency ablation outcome on pain experience in chronic low back pain (COPE): a single-blinded randomised controlled trial. RMD open, 10(2), Article e004196. https://doi.org/10.1136/rmdopen-2024-004196

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title = "Cryoneurolysis versus radiofrequency ablation outcome on pain experience in chronic low back pain (COPE): a single-blinded randomised controlled trial",

abstract = "OBJECTIVE: A comparison of cryoneurolysis or radio frequency (RF) with placebo in patients with facetogenic chronic low back pain (LBP) for patient global impression of change (PGIC), pain intensity, function and quality of life, with 1-year follow-up.DESIGN: Single-centre, single-blinded placebo-controlled randomised controlled trial.SETTING: Single-centre study.PARTICIPANTS: Inclusion from March 2020 to September 2022: consenting adults over 18 years of age, LBP>3 months, average Numeric Rating Scale LBP≥4 average last 14 days and a positive response to a diagnostic medial branch block ( >50% pain reduction after 60 min). INTERVENTIONS: 120 patients were block randomised 1:1:1 to cryoneurolysis, RF or placebo of the medial branch nerves. Physical therapy was added after 4 weeks for all groups.MAIN OUTCOME MEASURES: Primary outcome was PGIC 4 weeks after the intervention. Secondary outcomes included pain intensity (Numeric Rating Scale, NRS), quality of life (Short Form 36, EQ-5D-5L), disability (Oswestry Disability Index), depression (Major Depression Inventory) and catastrophising (Pain Catastrophising Scale). Outcomes were measured at 4 weeks, 3, 6 and 12 months.RESULTS: There was no statistically significant difference in PGIC at 4 weeks between cryoneurolysis and placebo (risk ratio (RR) 2; 95% CI 0.75 to 5.33, p=0.17) and RF and placebo (RR 1.6; 95% CI 0.57 to 4.49, p=0.37), except PGIC for cryoneurolysis at 6-month follow-up (RR 5.1; 95% CI 1.20 to 22.03, p=0.03). No statistically significant differences were found in secondary follow-up endpoints.CONCLUSIONS: Denervation of the medial branch nerve by either cryoneurolysis or RF compared with placebo did not demonstrate significant improvement in PGIC, pain intensity, function and quality of life in patients with facetogenic chronic LBP at short-term or long-term follow-up.TRIAL REGISTRATION NUMBER: NCT04786145.",

keywords = "Humans, Low Back Pain/therapy, Male, Female, Middle Aged, Quality of Life, Radiofrequency Ablation/methods, Chronic Pain/therapy, Treatment Outcome, Pain Measurement, Adult, Single-Blind Method, Cryosurgery/methods, Aged, Pain Management/methods",

author = "Kamilla Truong and Kaare Meier and Ahrens, {Lasse Cramer} and Wichmann, {Thea Overgaard} and Hamed Zaer and Tiroke, {Lasse Hubertus} and Simon Arvin and Mindaugas Bazys and Peter Duel and Gudrun Gudmundsdottir and Carlsen, {Jakob Gram} and Lone Nikolajsen and {van Tulder}, Maurits and S{\o}rensen, {Jens Christian Hedemann} and Rasmussen, {Mikkel Mylius}",

note = "{\textcopyright} Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",

year = "2024",

month = may,

day = "9",

doi = "10.1136/rmdopen-2024-004196",

language = "English",

volume = "10",

journal = "RMD open",

issn = "2056-5933",

publisher = "BMJ Publishing Group",

number = "2",

}

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, Sørensen, JCH & Rasmussen, MM 2024, 'Cryoneurolysis versus radiofrequency ablation outcome on pain experience in chronic low back pain (COPE): a single-blinded randomised controlled trial', RMD open, vol. 10, no. 2, e004196. https://doi.org/10.1136/rmdopen-2024-004196

TY - JOUR

T1 - Cryoneurolysis versus radiofrequency ablation outcome on pain experience in chronic low back pain (COPE)

T2 - a single-blinded randomised controlled trial

AU - Truong, Kamilla

AU - Meier, Kaare

AU - Ahrens, Lasse Cramer

AU - Wichmann, Thea Overgaard

AU - Zaer, Hamed

AU - Tiroke, Lasse Hubertus

AU - Arvin, Simon

AU - Bazys, Mindaugas

AU - Duel, Peter

AU - Gudmundsdottir, Gudrun

AU - Carlsen, Jakob Gram

AU - Nikolajsen, Lone

AU - van Tulder, Maurits

AU - Sørensen, Jens Christian Hedemann

AU - Rasmussen, Mikkel Mylius

N1 - © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2024/5/9

Y1 - 2024/5/9

N2 - OBJECTIVE: A comparison of cryoneurolysis or radio frequency (RF) with placebo in patients with facetogenic chronic low back pain (LBP) for patient global impression of change (PGIC), pain intensity, function and quality of life, with 1-year follow-up.DESIGN: Single-centre, single-blinded placebo-controlled randomised controlled trial.SETTING: Single-centre study.PARTICIPANTS: Inclusion from March 2020 to September 2022: consenting adults over 18 years of age, LBP>3 months, average Numeric Rating Scale LBP≥4 average last 14 days and a positive response to a diagnostic medial branch block ( >50% pain reduction after 60 min). INTERVENTIONS: 120 patients were block randomised 1:1:1 to cryoneurolysis, RF or placebo of the medial branch nerves. Physical therapy was added after 4 weeks for all groups.MAIN OUTCOME MEASURES: Primary outcome was PGIC 4 weeks after the intervention. Secondary outcomes included pain intensity (Numeric Rating Scale, NRS), quality of life (Short Form 36, EQ-5D-5L), disability (Oswestry Disability Index), depression (Major Depression Inventory) and catastrophising (Pain Catastrophising Scale). Outcomes were measured at 4 weeks, 3, 6 and 12 months.RESULTS: There was no statistically significant difference in PGIC at 4 weeks between cryoneurolysis and placebo (risk ratio (RR) 2; 95% CI 0.75 to 5.33, p=0.17) and RF and placebo (RR 1.6; 95% CI 0.57 to 4.49, p=0.37), except PGIC for cryoneurolysis at 6-month follow-up (RR 5.1; 95% CI 1.20 to 22.03, p=0.03). No statistically significant differences were found in secondary follow-up endpoints.CONCLUSIONS: Denervation of the medial branch nerve by either cryoneurolysis or RF compared with placebo did not demonstrate significant improvement in PGIC, pain intensity, function and quality of life in patients with facetogenic chronic LBP at short-term or long-term follow-up.TRIAL REGISTRATION NUMBER: NCT04786145.

AB - OBJECTIVE: A comparison of cryoneurolysis or radio frequency (RF) with placebo in patients with facetogenic chronic low back pain (LBP) for patient global impression of change (PGIC), pain intensity, function and quality of life, with 1-year follow-up.DESIGN: Single-centre, single-blinded placebo-controlled randomised controlled trial.SETTING: Single-centre study.PARTICIPANTS: Inclusion from March 2020 to September 2022: consenting adults over 18 years of age, LBP>3 months, average Numeric Rating Scale LBP≥4 average last 14 days and a positive response to a diagnostic medial branch block ( >50% pain reduction after 60 min). INTERVENTIONS: 120 patients were block randomised 1:1:1 to cryoneurolysis, RF or placebo of the medial branch nerves. Physical therapy was added after 4 weeks for all groups.MAIN OUTCOME MEASURES: Primary outcome was PGIC 4 weeks after the intervention. Secondary outcomes included pain intensity (Numeric Rating Scale, NRS), quality of life (Short Form 36, EQ-5D-5L), disability (Oswestry Disability Index), depression (Major Depression Inventory) and catastrophising (Pain Catastrophising Scale). Outcomes were measured at 4 weeks, 3, 6 and 12 months.RESULTS: There was no statistically significant difference in PGIC at 4 weeks between cryoneurolysis and placebo (risk ratio (RR) 2; 95% CI 0.75 to 5.33, p=0.17) and RF and placebo (RR 1.6; 95% CI 0.57 to 4.49, p=0.37), except PGIC for cryoneurolysis at 6-month follow-up (RR 5.1; 95% CI 1.20 to 22.03, p=0.03). No statistically significant differences were found in secondary follow-up endpoints.CONCLUSIONS: Denervation of the medial branch nerve by either cryoneurolysis or RF compared with placebo did not demonstrate significant improvement in PGIC, pain intensity, function and quality of life in patients with facetogenic chronic LBP at short-term or long-term follow-up.TRIAL REGISTRATION NUMBER: NCT04786145.

KW - Humans

KW - Low Back Pain/therapy

KW - Male

KW - Female

KW - Middle Aged

KW - Quality of Life

KW - Radiofrequency Ablation/methods

KW - Chronic Pain/therapy

KW - Treatment Outcome

KW - Pain Measurement

KW - Adult

KW - Single-Blind Method

KW - Cryosurgery/methods

KW - Aged

KW - Pain Management/methods

U2 - 10.1136/rmdopen-2024-004196

DO - 10.1136/rmdopen-2024-004196

M3 - Article

C2 - 38724261

SN - 2056-5933

VL - 10

JO - RMD open

JF - RMD open

IS - 2

M1 - e004196

ER -

Cryoneurolysis versus radiofrequency ablation outcome on pain experience in chronic low back pain (COPE): a single-blinded randomised controlled trial

Abstract

Bibliographical note

Funding

Keywords

Access to Document

Persistent URL (handle)

Fingerprint

Cite this