Status:
RECRUITING
Non-pharmacological Treatment vs Pharmacological Treatment for Non-acute Lumbar Disc Herniation
Lead Sponsor:
Jaseng Medical Foundation
Conditions:
Lumbar Disc Herniation
Eligibility:
All Genders
19-69 years
Phase:
NA
Brief 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...
Detailed Description
This is a pragmatic, multi-centered, randomized controlled, parallel-grouped study aiming to compare the effectiveness of a non-pharmacological treatment strategy and a active pharmacological treatmen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06024460
Start Date
August 9 2023
End Date
December 31 2030
Last Update
September 11 2025
Active Locations (4)
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1
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, South Korea, 135-896
2
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi-do, South Korea, 14598
3
Haeundae Jaseng Hospital of Korean Medicine
Busan, South Korea
4
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, South Korea