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
- PubMed: 40903674
- DOI: 10.1007/s00586-025-09316-8
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
No severe adverse events occurred.
- Finding
- Reported