pharmacological treatment strategy: Prescription medication, injection therapy, nerve blocks, or other pharmacological interventions commonly used for managing lumbar disc herniation.
This group is treated using the above treatment strategies, and no drug is specified.
Study summary
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.
Eligibility
Sex
ALL
Min age
19 Years
Max age
69 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Oswestry Disability Index (ODI) — Week 1, 5, 9, 13, 26, 39, 52, Month 18, 24, 36 The Oswestry Disability Index (ODI) is a questionnaire used to assess the functional status and degree of disability caused by lower back pain. It consists of 10 items that evaluate various aspects of daily activities and mobility. Each item is rated on a 6-point scale, with higher scores indicating a greater level of disability.
From 0 to 100. Higher scores mean a worse outcome.
Numeric Rating Scale for Pain of Dominant Change (NRS for DC) — Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 13, 26, 39, 52, Month 18, 24, 36 The study will evaluate the intensity of lower back pain and radiating leg pain using the Numeric Rating Scale (NRS). Patients will rate their pain levels on a scale from 0 to 10, where 0 represents no pain and 10 represents the most severe imaginable pain. The NRS for Dominant Change (NRS-DC) will be calculated as the higher value between the change in NRS scores from baseline for lower back pain and radiating leg pain. The NRS-DC will serve as a key evaluation indicator for pain intensity.
Trial sites (4)
Facility
City
Region
Status
Jaseng Hospital of Korean Medicine
Seoul
Gangnam-Gu
Recruiting
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si
Gyeonggi-do
Recruiting
Haeundae Jaseng Hospital of Korean Medicine
Busan
South Korea
Recruiting
Daejeon Jaseng Hospital of Korean Medicine
Daejeon
South Korea
Recruiting
More Jaseng Medical Foundation trials in South Korea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.