None listed
Conditions
Interventions
Procedure/Surgery : 1. Nerve block therapy
1) Drugs used in nerve block therapy
(1) Dexamethasone Sodium Phosphate 5mg/mL
(2) Emcaine injection 20ml
(3) Malinda Injection
(4) Huons Isotonic Sodiu
Sponsors
Catholic Kwandong University International St.Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult men and women aged 18-85 years. 2) Patients diagnosed with spondylosis with lumbosacral disc disorder (injury), spinal stenosis, or lumbosacral radiculopathy through radiological examination [magnetic resonance imaging (MRI) or computed tomography (CT)] within 6 months prior to participation in the clinical trial (in case of patients suspected of lumbosacral radiculopathy but with no imaging records at the time of screening test, MRI or CT scans are performed to check whether they meet the diagnostic criteria). 3) Patients with symptoms related to lumbosacral radiculopathy, such as radiological pain, muscle weakness, and paresthesia of the lower extremities or those diagnosed with radiculopathy of the lumbosacral spine through a physical examination. 4) Patients who underwent nerve block therapy within two weeks after the start of the clinical trial, and the patient’s subjective pain improvement is less than 50% after the procedure or the numeric rating scale (NRS) score being 5 or higher. 5) Patients who could read, understand, and answer the symptom questionnaire. 6) Patients who volunteered to participate and approved the written consent of the IRB while agreeing to the clinical trial plan and follow-up.
Exclusion criteria
Exclusion criteria: 1) Patients with a history of spinal surgeries, such as lumbar spine intrametallic fixation and spinal fusion, or those who have undergone past spinal surgery but continue to have related pain. 2) Patients with cauda equina syndrome or motor paralysis and neurological symptoms, which are expected to be difficult to treat with conservative therapy and require surgical treatment. 3) Patients undergoing drug treatments, such as strong opioid therapy, for pain control. 4) Patients who received acupotomy treatment within 2 weeks before the start of the clinical study (inclusion will be permitted despite treatment at another institution within the relevant period for reasons different from the indications defined for this clinical trial at the discretion of the clinical trial practitioner). 5) Patients who have experienced side effects or hypersensitivity reactions after nerve block therapy in the past. 6) Patients with acupuncture hypersensitivity, metal allergy, severe atopy, keloid skin, and other skin sensitivities. 7) Patients with hemophilia. 8) Patients who are taking drugs that can cause hemostasis, such as anticoagulants, antiplatelet drugs, aspirin, etc., wherein it is not possible to stop the drug during the clinical trial period, according to the judgment of the clinical trial practitioner. 9) Patients who participated in other clinical studies within 30 days prior to the screening of the current clinical study and received investigational drugs, including placebos. 10) Patients with psychotic disorders, alcoholics, and drug addicts. 11) Pregnant women, lactating women, and women of childbearing potential who are not willing to use contraception during the clinical trial. 12) Patients who are judged to be inappropriate for participation in clinical trials by the clinical trial practitioner.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oswestry low back disability questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| NRS of low back and radiating pain;The 5-level European Quality of Life 5 Dimension(EQ-5D-5L);McGill pain Questionnaire;Roland Morris Disability Questionnaire;Additional procedure or surgery perform rate;Premature termination rate;Use of rescue drug;Cost-effectiveness assessment(Direct medical expenses, Direct non-medical expenses, iMTA Productivity Cost Questionnaire);Safety assessment(Physical examination, Vital sign, PRO-CTCAE, Adverse events);Treatment responder, non-responder assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactJin-Hyun Lee
Catholic Kwandong University International St.Mary's Hospital
Outcome results
None listed