RecruitingNot ApplicableNCT06024460

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

Comparative Effectiveness of Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation: a Multi-centered, Pragmatic Randomized Controlled, Parallel-grouped Study


Sponsor

Jaseng Medical Foundation

Enrollment

200 participants

Start Date

Aug 9, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 YearsMax Age: 69 Years

Inclusion Criteria5

  • 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 Criteria12

  • 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.

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Interventions

PROCEDUREnon-pharmacological treatment strategy

Acupuncture, elctroacupuncture, spinal manual therapy, motion style acupucnture treatment

PROCEDUREpharmacological 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.


Locations(4)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi-do, South Korea

Haeundae Jaseng Hospital of Korean Medicine

Busan, South Korea

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, South Korea

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NCT06024460


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