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

Cryoneurolysis versus Radiofrequency Ablation for Chronic Low Back Pain

Key Findings:

A study compared cryoneurolysis and radiofrequency (RF) with a placebo for patients with chronic low back pain. The primary goal was to assess patient global impression of change (PGIC), pain intensity, function, and quality of life over a 1-year period.

Study Design:

The research was a single-blinded, placebo-controlled randomized trial conducted at a single center. It included consenting adults over 18 years old with chronic low back pain and a positive response to a diagnostic medial branch block.

Interventions:

120 patients were randomly assigned to receive cryoneurolysis, RF, or a placebo of the medial branch nerves. All groups also received physical therapy after 4 weeks.

Outcomes:

The primary outcome measured patient global impression of change (PGIC) at 4 weeks after the intervention. Secondary outcomes included pain intensity, quality of life, disability, depression, and catastrophizing, measured at 4 weeks, 3, 6, and 12 months.

Results:

There was no significant difference in PGIC at 4 weeks between cryoneurolysis and placebo, or RF and placebo. However, at the 6-month follow-up, cryoneurolysis showed a significant improvement in PGIC. No significant differences were found in the secondary follow-up endpoints.

Conclusions:

Denervation of the medial branch nerve by cryoneurolysis or RF did not demonstrate significant improvement in PGIC, pain intensity, function, and quality of life in patients with chronic low back pain at short-term or long-term follow-up.

Practical Solutions:

Clinical trials are essential for developing safe and effective treatments. Our AI-driven platform, DocSym, consolidates clinical protocols and research into an easily accessible knowledge base for clinicians. Additionally, our mobile apps support scheduling, monitoring treatments, and telemedicine, streamlining operations and improving patient outcomes.

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