Non-pharmacological Treatment vs Pharmacological Treatment for Non-acute Lumbar Disc Herniation

Recruiting now · Not applicable

Conditions studied: Lumbar Disc Herniation

In brief

This is a randomized controlled study comparing non-pharmacological treatment to proactive pharmacological treatment for patient with non-acute lumbar disc herniation with moderate or higher levels of pain. The study involves 200 adult patients aged 19-69, with 50 patients from each participating hospital. Patients will be randomly assigned to either the non-pharmacological treatment group or the pharmacological treatment group 1:1 ratio. Specific interventions will be determined by doctors and Korean medicine doctors without predefined treatment strategies. The non-pharmacological treatment include acupuncture, electroacupuncture, spinal manual therapy and motion style acupuncture. The pharmacological treatment include medication prescription, injection, and nerve block. Treatment period is 8 weeks, and f/u for 3 years.

Key facts

Study ID

NCT06024460

Run by

Jaseng Medical Foundation

People needed

200

Starts

2023-08-09

Expected to finish

2030-12-31

Last updated by the study team

2025-09-11

Who can join

Age: 19 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• aged 19 to 69 years.
• lower back pain that has persisted for at least 1 month.
• a Numeric Rating Scale (NRS) score of 5 or higher for either lower back pain or radiating leg pain over the past three consecutive days.
• confirmed lumbar disc herniation on MRI that can explain the lower back pain.
• who have provided written informed consent and agreed to participate in the clinical study.

You may not qualify if…

• diagnosed with specific severe diseases that could be the cause of lower back pain or leg pain (e.g., spinal metastasis, acute fractures, and spinal dislocation).
• showing progressive neurological deficits or severe neurological symptoms.
• with pain originating from soft tissue disorders other than the spine (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout).
• with other chronic conditions (e.g., stroke and myocardial infarction, renal disease, diabetic neuropathy, dementia, epilepsy) that may interfere with the treatment effect or result interpretation.
• taking steroids, immunosuppressive drugs, psychiatric medications, or other medications that may impact the study results.
• acupuncture or nerve block treatment is inappropriate or unsafe, such as those with a history of bleeding disorders, receiving anticoagulant therapy, or diagnosed with uncontrolled diabetes.
• taken non-steroidal anti-inflammatory drugs (NSAIDs) or other pain-affecting drugs or received acupuncture treatment within the past 5 days.
• Pregnant women, those planning pregnancy, or breastfeeding women.
• within 3 months after lumbar surgery.
• who have not completed participation in another clinical study within the past month or have plans to participate in another clinical study within 6 months from the selection date or during the study participation and follow-up period.
• Inability to provide written informed consent.
• Other cases where the researchers determine that participation in the clinical study would be difficult.

Where it is running

• Jaseng Hospital of Korean Medicine — Seoul, Gangnam-Gu, South Korea (enrolling)
• Bucheon Jaseng Hospital of Korean Medicine — Bucheon-si, Gyeonggi-do, South Korea (enrolling)
• Haeundae Jaseng Hospital of Korean Medicine — Busan, South Korea (enrolling)
• Daejeon Jaseng Hospital of Korean Medicine — Daejeon, South Korea (enrolling)

Full record on ClinicalTrials.gov

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