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.
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.
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.
Parallel
non-pharmacological treatment strategy
Procedure/SurgeryAcupuncture, elctroacupuncture, spinal manual therapy, motion style acupucnture treatment
pharmacological treatment strategy
Procedure/SurgeryPrescription 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.
Oswestry Disability Index (ODI)
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)
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.
Recurrence
This study will confirm the recurrence of symptoms in patients through a yes or no response.
Numeric Rating Scale (NRS) for Low Back Pain
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participants are asked to report their low back pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable.
Patient Global Impression of Change (PGIC)
Participants rate the improvement after treatment on a 7-point Likert scale (1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)
Fear-Avoidance Beliefs Questionnaire (FABQ)
The fear-avoidance belief questionnaire (FABQ) is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear. Minimum 0 to maximum 66 scores. Higher score means a worse outcome.
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