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Evidence-Based Supplement Research
Evidence-Based Supplement Research

Efficacy and safety of low-temperature plasma radiofrequency ablation combined with ozone injection versus triple therapy including collagenase for cervical disc herniation: a randomized controlled trial.

  • 2025-09-04
  • European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society 35(4)
    • Ying Yang
    • Zhenguo Gao
    • Yulin Zhang
    • Qifan Fang
    • Jiang Liu
    • Yongming Zhao
    • Zeyu Wu

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 90
Population
90 eligible CDH patients (30-80 years, single-level protrusion ≤ 1/3 spinal canal)
Methods
Prospective RCT, low-temperature plasma radiofrequency ablation combined with ozone injection versus same dual therapy with additional collagenase
Duration
6 months

Objective

To compare the efficacy and safety of low-temperature plasma radiofrequency ablation combined with ozone injection versus the same dual therapy with additional collagenase for cervical disc herniation (CDH).

Methods

A prospective RCT enrolled 90 eligible CDH patients (30-80 years, single-level protrusion ≤ 1/3 spinal canal) at a tertiary hospital, randomizing them to a study group (n = 45, triple therapy) or control group (n = 45, low-temperature plasma radiofrequency ablation + ozone). Visual Analogue Scale (VAS) and Japanese Orthopaedic Association (JOA) scores were compared preoperatively and at 1 week, 1, 3, and 6 months postoperatively, with efficacy assessed via Modified MacNab Criteria.

Results

At 6 months, the study group showed significantly better VAS and JOA scores (P < 0.05) and a 6-month excellent rate of 93.33% vs. 75.56% in controls (P < 0.05). Both groups improved postoperatively, with no early differences. No severe adverse events occurred.

Conclusion

The addition of collagenase to ablation and ozone therapy significantly enhances long-term pain relief and functional recovery in CDH patients without increasing safety risks.

Research Insights

  • At 6 months, the study group showed significantly better VAS and JOA scores (P < 0.05) and a 6-month excellent rate of 93.33% vs. 75.56% in controls (P < 0.05).

    Effect
    Beneficial
    Effect size
    Large
  • At 6 months, the study group showed significantly better VAS and JOA scores (P < 0.05) and a 6-month excellent rate of 93.33% vs. 75.56% in controls (P < 0.05).

    Effect
    Beneficial
    Effect size
    Large

Adverse Events Reported

  • CollagenaseOverall tolerability

    No severe adverse events occurred.

    Finding
    Reported
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