NCT06024460 Non-pharmacological Treatment vs Pharmacological Treatment for Non-acute Lumbar Disc Herniation
| NCT ID | NCT06024460 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jaseng Medical Foundation |
| Condition | Lumbar Disc Herniation |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-08-09 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-08-09 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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.
Contact & Investigator
In-Hyuk Ha, Dr
STUDY DIRECTOR
Jaseng Medical Foundation
Frequently Asked Questions
Who can join the NCT06024460 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 69 Years, studying Lumbar Disc Herniation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06024460 currently recruiting?
Yes, NCT06024460 is actively recruiting participants. Contact the research team at hanihata@gmail.com for enrollment information.
Where is the NCT06024460 trial being conducted?
This trial is being conducted at Seoul, South Korea, Bucheon-si, South Korea, Busan, South Korea, Daejeon, South Korea.
Who is sponsoring the NCT06024460 clinical trial?
NCT06024460 is sponsored by Jaseng Medical Foundation. The principal investigator is In-Hyuk Ha, Dr at Jaseng Medical Foundation. The trial plans to enroll 200 participants.