Effectiveness and Safety of Pharmacopunture Therapy for Chronic Low Back Pain: A Pragmatic Randomized Controlled Trial

Effectiveness and Safety of Pharmacopunture Therapy for Chronic Low Back Pain: A Pragmatic Randomized Controlled Trial

This is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain.

This is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain. Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (50:50) for pharmacopuncture therapy group and physical therapy group. Participants of each group will receive total 5 weeks of intervention. This is a pragmatic randomized controlled trial, so physicians will have medical decision making according to each participant's conditions and choose the specific type and volume of pharmacopuncture and physical therapy.

Inclusion Criteria:

1. low back pain for more than 6 months
2. Numeric rating scale (NRS) score for low back pain 5 or more
3. 19-70 years old
4. participants who agreed and signed informed consent form

Exclusion Criteria:

1. Spine metastasis of cancer, acute fracture of spine, or spine dislocation
2. Progressive neurologic deficits or severe neurologic deficits
3. Soft tissue diseases that can induce low back pain (ie. cancer, fibromyalgia, rheumatoid arthritis, gout, etc)
4. Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc)
5. Concurrent use of steroids, immunosuppressants, or psychotropic medications
6. Hemorrhagic disease, severe diabetes or taking anticoagulant drug
7. Participants who took NSAIDs or pharmacopuncture within 1 week
8. Pregnant or lactating women
9. Participants who had undergone lumbar surgery within 3 months
10. Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial
11. Participants who can not write informed consent
12. Participants who is difficult to participate in the trial according to investigator's decision