A comparative study of a deeply-inserted acupotomy applied to Hyeopcheok points and usual Korean Medicine treatments for lumbosacral radiculopathy: safety, effectiveness, cost-effectiveness (A randomized controlled, two-arm, parallel study, pilot study, assessor-blind)
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0006043
- Lead Sponsor
- Catholic Kwandong University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
1) Adult men and women aged 19-85
2) Those who have been diagnosed with spondylosis with lumbosacral disc disorder (injury), spinal stenosis, lumbosacral radiculopathy. through radiological examination (MRI or CT) within 6 months prior to participation in the clinical trial (In the case of a patient suspected of lumbosacral radiculopathy but no imaging record at the time of the screening test, MRI or CT scans are performed to check whether it meets the diagnostic criteria)
3) Patients who have symptoms related to lumbosacral radiculopathy, such as radiological pain, muscle weakness, and paresthesia of the lower extremities, or who have been diagnosed with radiculopathy of the lumbosacral spine through a physical examination.
4) Patients with NRS 4 or higher with pain/discomfort due to lumbosacral radiculopathy
5) Patients who read the symptom questionnaire and can understand and answer its meaning
6) Patients who voluntarily consent to the approved written consent of the Institutional Review Board while agreeing to the clinical trail plan and follow-up
1) Patients who have a history of spinal surgery such as lumbar spine intrametallic fixation and spinal fusion, or who have undergone past spinal surgery but continue to have related pain afterwards
2) Patients with cauda equina syndrome or motor paralysis and neurological symptoms, which are expected to be difficult to recover with conservative therapy, and who are judged to require surgical treatment
3) Patients undergoing drug treatment such as strong opioid for the purpose of pain control
4) Patients who received Korean medicine treatment within 2 weeks before the start of the clinical study baseline
(If, at the discretion of the clinical trial practitioner, treatment at another institution within the relevant period is determined to be a new neuropathic symptom different from the existing pain, it is possible to participate in this clinical trial)
5) Patients with acupuncture hypersensitivity, metal allergy, severe atopy, keloid skin, and other skin sensitivity
6) Patients with hemophilia
7) Patients who are taking drugs that can cause hemostasis, such as anticoagulants, antiplatelet drugs, aspirin, etc., and that it is not possible to stop the drug during the clinical trial period at the judgment of the clinical trial practitioner.
8) Those who participated in other clinical studies within 30 days prior to clinical study screening and received investigational drugs including placebo
9) Patients with psychotic disorder, alcoholics, and drug addicts
10) Pregnant and lactating women, women of childbearing potential who are not willing to use contraception during the clinical trial
11) Those who is judged to be inappropriate for participation in clinical trials as judged by the clinical trial practitioner.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Oswestry low back disability questionnaire
- Secondary Outcome Measures
Name Time Method RS 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 prodecure 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