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 2% VIAL 20ml
(3) 1500 IU of Echirase Injection
(4) Normal Sa
Sponsors
Catholic Kwandong University International St.Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult men and women aged 19-85 years. 2) Patients diagnosed with spondylosis with cervical disc disorder (injury), spinal stenosis, or spondylosis with 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 cervical 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 cervical radiculopathy, such as radiological pain, muscle weakness, and paresthesia of the upper extremities or those diagnosed with radiculopathy of the cervical spine through a physical examination. 4) Patients with cervical or upper extremity pain due to cervical radiculopathy with NRS 4 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) Patient with a history of spinal surgeries, such as cervical spine intrametallic fixation and spinal fusion, or those who have undergone past spinal surgery but continue to have related pain. 2) Patients with cervical myelopathy 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 have been treated with acupotomy or pharmacopuncture within 2 weeks prior to the start of study baseline (however, patients who have been treated at another institution within that time period for reasons other than the indication for this study, as determined by the investigator, may be eligible to participate in this study). 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 |
|---|---|
| neck disability index | — |
Secondary
| Measure | Time frame |
|---|---|
| NRS of cervical and upper extremity radiating pain;The 5-level European Quality of Life 5 Dimension(EQ-5D-5L);Northwick Park Neck Pain Questionnaire(NPQ);Additional procedure or surgery perform rate;Premature termination rate;Use of rescue drug;Safety assessment(Physical examination, Vital sign, PRO-CTCAE, Adverse events) | — |
Countries
Korea, Republic of
Contacts
Public ContactJin-Hyun Lee
Catholic Kwandong University International St.Mary's Hospital
Outcome results
None listed