KCT0009541
Recruiting
未知
A comparative study of a nerve block therapy with and without a deeply-inserted acupotomy applied to Hyeopcheok points for lumbosacral radiculopathy : safety, effectiveness, cost-effectiveness (A randomized controlled, two-arm, parallel study, assessor-blind)
Catholic Kwandong University International St.Mary's Hospital0 sites114 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Catholic Kwandong University International St.Mary's Hospital
- Enrollment
- 114
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •1\) Patients with a history of spinal surgeries, such as lumbar spine intrametallic fixation and spinal fusion.
- •2\) Patients who have undergone past spinal surgery but continue to have related pain.
- •3\) 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.
- •4\) Patients undergoing drug treatments, such as strong opioid therapy, for pain control.
- •5\) 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).
- •6\) Patients who have experienced side effects or hypersensitivity reactions after nerve block therapy in the past.
- •7\) Patients with acupuncture hypersensitivity, metal allergy, severe atopy, keloid skin, and other skin sensitivities.
- •8\) Patients with hemophilia.
- •9\) 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.
- •10\) 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.
Outcomes
Primary Outcomes
Not specified
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