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

Launched by JASENG MEDICAL FOUNDATION · Aug 29, 2023

Keywords

ClinConnect Summary

This clinical trial is comparing two different types of treatments for adults dealing with moderate to severe lower back pain caused by a condition known as lumbar disc herniation, which is when a disc in the lower back bulges out and presses on nerves. The study involves 200 participants aged 19 to 69 years, who have had back pain for at least a month and have a pain score of 5 or higher. Some people will receive non-drug treatments like acupuncture and spinal therapy, while others will receive medications or injections. The treatment will last for 8 weeks, and researchers will follow up with participants for three years to see how effective each treatment is.

To join the study, individuals must meet specific criteria, including having a confirmed diagnosis of lumbar disc herniation and not having certain serious health issues that could affect their back pain or the results of the study. During the trial, participants will receive care tailored to their needs, and they will help researchers learn more about the best ways to treat this condition. It's important for potential participants to discuss any medications they are taking and their overall health with their doctor to see if they qualify for the study.

Gender

ALL

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.