Comparing non-drug treatments to drug treatments for 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
This study is testing whether non-drug treatments like acupuncture and manual therapy work better than medication for adults with moderate to severe pain from lumbar disc herniation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 19 Years to 69 Years |
| Sex | All |
| Sponsor | Jaseng Medical Foundation Academic / other |
| Locations | 4 sites (Seoul, Gangnam-Gu and 3 other locations) |
| Trial ID | NCT06024460 on ClinicalTrials.gov |
What this trial studies
This randomized controlled study aims to compare the effectiveness of non-pharmacological treatments, such as acupuncture and spinal manual therapy, against pharmacological treatments for patients suffering from non-acute lumbar disc herniation with moderate or higher pain levels. A total of 200 adult patients aged 19 to 69 will be recruited from multiple hospitals, with participants randomly assigned to either treatment group in a 1:1 ratio. The specific interventions will be determined by the treating physicians based on clinical judgment, and the treatment period will last for 8 weeks, followed by a 3-year follow-up. The study seeks to provide insights into the best management strategies for this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 69 with lumbar disc herniation and moderate to severe pain persisting for over a month.
Not a fit: Patients with severe underlying conditions or specific neurological deficits may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer patients effective non-drug alternatives for managing lumbar disc herniation pain.
How similar studies have performed: Other studies have shown promising results with non-pharmacological treatments for similar conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul, Gangnam-Gu and 3 other locations
- Jaseng Hospital of Korean Medicine — Seoul, Gangnam-Gu, South Korea (Recruiting)
- Bucheon Jaseng Hospital of Korean Medicine — Bucheon-si, Gyeonggi-do, South Korea (Recruiting)
- Haeundae Jaseng Hospital of Korean Medicine — Busan, South Korea (Recruiting)
- Daejeon Jaseng Hospital of Korean Medicine — Daejeon, South Korea (Recruiting)
Study contacts
- Study coordinator: In-Hyuk Ha, Dr
- Email: hanihata@gmail.com
- Phone: +82-2-2222-2740
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.