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NCT07832318
Effectiveness and Safety of Pharmacopuncture Therapy for Chronic Lumbar Radiculopathy: A Multicenter, Pragmatic, Randomized, Comparative Clinical Trial
Conditions: Lumbar Radiculopathy, Chronic Pain
Sex: All
Ages: 19 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 92
Sponsor: Jaseng Medical Foundation
Location: Bucheon Jaseng Hospital of Korean Medicine Bucheon-si Gyeonggi-do
Summary
A pragmatic clinical study to compare the effectiveness of pharmacopuncture and physical therapy strategies in patients with chronic lumbar radiculopathy
Eligibility Criteria
1\. Inclusion Criteria:
1. Persistent sciatica symptoms lasting for more than 3 months.
2. Presence of at least one of the following signs in one or both lower extremities: Muscle weakness / Dermatomal sensory disturbance (hypoesthesia, dysesthesia, tingling, or pain) / Decreased reflexes / Radiating pain aggravated by the Straight Leg Raising (SLR) test
3. Numeric Rating Scale (NRS) score of 4 or higher for leg pain.
4. Aged between 19 and 70 years.
5. Provided written informed consent to participate in the clinical trial.
2\. Exclusion Criteria:
1. Diagnosed with serious conditions that may cause lower limb radiating pain (e.g., spinal metastasis of cancer, acute vertebral fracture, or dislocation).
2. Presence of progressive neurological deficits or severe neurological symptoms.
3. Pain originating from non-spinal soft tissue disorders (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout).
4. Presence of chronic diseases that may interfere with treatment outcomes or interpretation (e.g., stroke, myocardial infarction, renal disease, diabetic neuropathy, dementia, epilepsy).
5. Current use of steroids, immunosuppressants, psychiatric medications, or other drugs that may affect study outcomes.
6. Inappropriate or unsafe conditions for pharmacopuncture, including bleeding disorders, anticoagulant therapy, or severe diabetes with high infection risk.
7. Use of analgesic medications such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), or receipt of acupuncture, pharmacopuncture, or physical therapy within the past 7 days.
8. Pregnant, planning to become pregnant, or currently breastfeeding.
9. Within 3 months post-lumbar spine surgery.
10. Participation in another clinical trial within the past month, or planned participation in another clinical trial (including follow-up period) within 6 months from the screening date.
11. Difficulty in completing the informed consent process.
12. Any other condition that the investigator deems inappropriate for participation in the clinical trial.
Source: ClinicalTrials.gov (NCT07832318). StuddyBuddy aggregates publicly available trial information.