Non-Pharmacological and Pharmacological Treatments for Non-Acute Lumbar Disc Herniation: A Protocol for a Multicenter Pragmatic Trial.
Doori Kim, Yoon Jae Lee, Changsop Yang...
https://pubmed.ncbi.nlm.nih.gov/41477591Actively Recruiting
Phase Not Applicable
Age: 19Years - 69Years
All Genders
ID06024460
Comparative Effectiveness of Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation: a Multi-centered, Pragmatic Randomized Controlled, Parallel-grouped Study
Led by Jaseng Medical Foundation · Updated on 2025-09-11
200
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing non-pharmacological treatments with proactive pharmacological treatments for adults aged 19 to 69 who have non-acute lumbar disc herniation with moderate or higher pain lasting more than one month. This pragmatic, multi-centered randomized controlled study involves 200 patients from several hospitals, aiming to evaluate which treatment strategy better manages symptoms and improves function. Participants will be randomly assigned to either a non-pharmacological group receiving acupuncture, electroacupuncture, spinal manual therapy, and motion style acupuncture, or a pharmacological group receiving prescription medications, injections, or nerve blocks. Treatments are recommended twice a week for eight weeks, but frequency and specifics may be adjusted by doctors based on individual symptoms and clinical judgment. Patients can also choose additional therapies, with all treatment details recorded for comparison. During the study, patients will have weekly evaluations of symptoms and treatment progress. Outcome measures include disability and pain scales assessed at multiple time points up to three years, as well as questionnaires on quality of life, fear-avoidance beliefs, global impression of change, and work productivity. Safety and recurrence of symptoms will also be monitored throughout the follow-up period.
CONDITIONS
Brief Title
Non-pharmacological Treatment vs Pharmacological Treatment for Non-acute Lumbar Disc Herniation
Who Can Participate
Age: 19Years - 69Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 19 to 69 years
- Lower back pain lasting at least 1 month
- Numeric Rating Scale score of 5 or higher for lower back pain or radiating leg pain over the past three days
- Lumbar disc herniation confirmed by MRI that explains the lower back pain
- Provided written informed consent and agreed to participate in the study
You will not qualify if you...
- Diagnosed with severe diseases causing lower back or leg pain (e.g., spinal metastasis, acute fractures, spinal dislocation)
- Progressive neurological deficits or severe neurological symptoms
- Pain from soft tissue disorders other than the spine (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout)
- Chronic conditions that may interfere with treatment or results (e.g., stroke, myocardial infarction, renal disease, diabetic neuropathy, dementia, epilepsy)
- Taking steroids, immunosuppressive drugs, psychiatric medications, or other drugs affecting study results
- Conditions making acupuncture or nerve block unsafe (e.g., bleeding disorders, anticoagulant therapy, uncontrolled diabetes)
- Used NSAIDs, other pain-affecting drugs, or acupuncture within the past 5 days
- Pregnant, planning pregnancy, or breastfeeding
- Lumbar surgery within past 3 months
- Not completed another clinical study within past month or planning to participate in another within 6 months
- Unable to provide written informed consent
- Other conditions judged by researchers as making participation difficult
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 weeks
Participants receive either a non-pharmacological treatment strategy including acupuncture and spinal manual therapy, or an active pharmacological treatment strategy including prescription medication and injection therapy. Treatments are recommended twice a week for eight weeks, with adjustments based on individual conditions.
Twice-weekly visits for up to 8 weeks
Follow-up
Duration - Up to 36 months
Participants are monitored through periodic assessments to evaluate the effectiveness and safety of the treatments over time.
Multiple follow-up visits at Weeks 9, 13, 26, 39, 52, and Months 18, 24, and 36
Trial Site Locations
Total: 4 locations
1
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, South Korea, 135-896
Actively Recruiting
2
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi-do, South Korea, 14598
Actively Recruiting
3
Haeundae Jaseng Hospital of Korean Medicine
Busan, South Korea
Actively Recruiting
4
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, South Korea
Actively Recruiting
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Research Team
I
In-Hyuk Ha, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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