Comparing non-drug treatments to drug treatments for lumbar disc herniation

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 randomized controlled study aims to compare the effectiveness of non-pharmacological treatments, such as acupuncture and spinal manual therapy, against pharmacological treatments for patients suffering from non-acute lumbar disc herniation with moderate or higher pain levels. A total of 200 adult patients aged 19 to 69 will be recruited from multiple hospitals, with participants randomly assigned to either treatment group in a 1:1 ratio. The specific interventions will be determined by the treating physicians based on clinical judgment, and the treatment period will last for 8 weeks, followed by a 3-year follow-up. The study seeks to provide insights into the best management strategies for this condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

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

Study contacts

• Study coordinator: In-Hyuk Ha, Dr
• Email: hanihata@gmail.com
• Phone: +82-2-2222-2740

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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.