Pharmacopuncture vs. physical therapy for chronic lumbar radiculopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, pragmatic randomized trial compares pharmacopuncture to physical therapy in adults with chronic lumbar radiculopathy. Ninety-two participants will be randomly assigned to 46 receive pharmacopuncture and 46 receive physical therapy, with treatments guided by each patient’s clinical condition. The study emphasizes real-world practice by not fixing the exact treatment methods in advance and by documenting all interventions in medical records for analysis. Primary goals are to assess relative effectiveness and safety in managing leg pain and related symptoms in a typical clinical setting. Recruitment occurs at four traditional Korean medicine hospitals in Korea.

Why it matters

Who can join: the full rules

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.

Where it's running

• Kyung Hee University Korean Medicine Hospital at Gangdong
  Seoul, Seoul, South Korea Recruiting
• Bucheon Jaseng Hospital of Korean Medicine
  Bucheon-si, Gyeonggi-do, South Korea Completed
• Kyung Hee University Korean Medicine Hospital at Gangdong
  Seongnam-si, Gyeonggi-do, South Korea Completed
• Jaseng Hospital of Korean Medicine
  Seoul, Seoul, South Korea Completed

Study contacts

• Study coordinator: In-Hyuk Ha, Dr
• Email: hanihata@gmail.com
• Phone: 1577-0007

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.