Actively Recruiting

Phase Not Applicable
Age: 19Years - 69Years
All Genders
NCT06024460

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

Led by Jaseng Medical Foundation · Updated on 2025-09-11

200

Participants Needed

4

Research Sites

385 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years - 69Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 19 to 69 years
  • Lower back pain lasting at least 1 month
  • Numeric Rating Scale score of 5 or higher for lower back or radiating leg pain over the past 3 consecutive days
  • Confirmed lumbar disc herniation on MRI explaining the pain
  • Provided written informed consent to participate
Not Eligible

You will not qualify if you...

  • Diagnosed with serious diseases causing back or leg pain such as spinal metastasis, acute fractures, or spinal dislocation
  • Progressive neurological deficits or severe neurological symptoms
  • Pain from soft tissue disorders other than the spine like tumors or fibromyalgia
  • Chronic conditions like stroke, myocardial infarction, renal disease, diabetic neuropathy, dementia, or epilepsy that may affect treatment
  • Taking steroids, immunosuppressants, psychiatric medications, or other drugs affecting study results
  • Conditions making acupuncture or nerve block unsafe, including bleeding disorders, anticoagulant use, or uncontrolled diabetes
  • Used NSAIDs, pain medications, or acupuncture within 5 days before the study
  • Pregnant, planning pregnancy, or breastfeeding
  • Within 3 months after lumbar surgery
  • Participated in another clinical study within the past month or planning to participate in one during this study or follow-up
  • Unable to provide written informed consent
  • Other conditions deemed by researchers to make participation difficult

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea, 135-896

Actively Recruiting

2

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi-do, South Korea, 14598

Actively Recruiting

3

Haeundae Jaseng Hospital of Korean Medicine

Busan, South Korea

Actively Recruiting

4

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, South Korea

Actively Recruiting

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Research Team

I

In-Hyuk Ha, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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