None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : • Treatment group: Inject 10-20 mL of levobupivacaine solution (0.25%
) into the epidural bolus around the disc lesion.Then, 10 mL of ozone (oxygen / ozone mixed gas
concentration 20 µg / mL) is administered to the disc lesion through the injection needle. Of these, 1 to 3 mL of ozone is injected into the disc lesion, and the remaining 7 to 9 mL is injected into t
is injected into the epidural bolus around the disc lesion.Then, a needle without ozone is inserted into the disc lesion (simulated therapy).
Sponsors
Healthwell Medical
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The degree of improvement of the number of pain class (NRS) at 4 weeks after the therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| The degree of improvement of the number of pain class (NRS) at 4, 8 weeks after the therapy;Oswestry Disability Index (ODI) and quality of life (EQ-5D) improvement at 4, 8, and 12 weeks after the therapy;Satisfaction scale (5-point Linkert scale) at 4, 8, and 12 weeks after the therapy;Safety assessment: Adverse events, vital signs, laboratory tests | — |
Countries
Korea, Republic of
Contacts
Public ContactJiyeon Moon
Seoul National University Hospital
Outcome results
None listed