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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-69
SponsorJaseng Medical Foundation

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • non-pharmacological treatment strategy
  • pharmacological treatment strategy

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators