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

University of Aarhus

Status: Unknown

Conditions: Chronic Low-back Pain; Degeneration Lumbar Spine; Back Pain Lower Back Chronic; Facet Joint Pain; Facet Joint Syndrome

Treatments: Procedure: Cryoneurolysis; Procedure: Placebo; Procedure: Radiofrequency ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04786145

COPE

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups

Cryoneurolysis

Active Comparator group

Description:

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

Treatment:

Procedure: Cryoneurolysis

Radiofrequency ablation

Active Comparator group

Description:

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

Treatment:

Procedure: Radiofrequency ablation

Placebo

Sham Comparator group

Description:

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

Treatment:

Procedure: Placebo