KCT0003917尚未招募未知
Single-center, randomized, double-blind, placebo-controlled, prospective comparative pilot clinical trial to assess the efficacy and safety of oxygen / ozone therapy for patients suffering from pain due to lumbar disc herniation
Healthwell Medical0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 85(Year)（—）
- 性别
- All
入选标准
- •1) Male and female patients aged 19 to 85
- •2) NRS (numeric Response Score) scores greater than 4/10 and less than 8/10 despite 3 or more months of conservative treatment (physical therapy, exercise therapy, oral medication, epidural block) A complaining patient
- •3) Patients with changes in the L1 / 2 to L5 / S1 intervertebral disc (bulging, protrusion, extrusion) and complaints of radicular pain
- •4) If the patient complains of bilateral leg pain, the patient with the main side of both sides
- •5) Those who agreed in writing
排除标准
- •1) Patients with spinal infection confirmed by MRI
- •2) Patients with spinal cord injury confirmed by MRI
- •3) Patients with severe neurological impairment at the site or below the nerve (Frankel Grade C or lower - physical exercise is conserved but weak enough to not be used for useful purposes, and senses may not be preserved or preserved)
- •4) Patients who were diagnosed with causative diseases (posterior joint syndrome, cephalic arthritis, etc.) other than the herniated disc
- •5) Those who have allergies to asthma or ozone that are not well controlled
- •6) Patients with a history of glucose-6-phosphate dehydrogenase deficiency and a moderate degree of enzyme activity in the WHO
- •7) Patients with markedly low serum TSH with clinical symptoms of hyperthyroidism
- •8) A person whose signs of vitality are one of the following:
- •Systolic blood pressure:> 140 mmHg or <100 mmHg
- •Diastolic blood pressure:> 90 mmHg or <60 mmHg
- •Pulse rate: =100 times
- •9) Pregnant or lactating women
- •10) Those who are deemed to be ineligible to take part in the clinical trial due to clinical laboratory test results or other reasons
- •11) Patients who can not treat ozone (patients with a high risk of bleeding)
- •12) Patients who can not be tested by MRI
- •13) Patients with major diseases other than the target disease
- •14) Patients with hypersensitivity to local anesthetics or amide-based topical anesthetics used in this study
- •15) Patients with inflammation at or near the injection site
- •16) Patients with severe hypotension
- •17) Patients with massive bleeding or shock
- •18) Those who participated in other clinical trials within 90 days before participating in this clinical trial
研究者
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