Effectiveness and Safety of Pharmacopunture Therapy for Chronic Low Back Pain: A Pragmatic Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Low-back Pain
- Sponsor
- Jaseng Medical Foundation
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- Numeric rating scale (NRS) of low-back pain
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
In-Hyuk Ha, KMD
Director of Jaseng Spine and Joint Research Institute
Jaseng Medical Foundation
Eligibility Criteria
Inclusion Criteria
- •low back pain for more than 6 months
- •Numeric rating scale (NRS) score for low back pain 5 or more
- •19-70 years old
- •participants who agreed and signed informed consent form
Exclusion Criteria
- •Spine metastasis of cancer, acute fracture of spine, or spine dislocation
- •Progressive neurologic deficits or severe neurologic deficits
- •Soft tissue diseases that can induce low back pain (ie. cancer, fibromyalgia, rheumatoid arthritis, gout, etc)
- •Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc)
- •Concurrent use of steroids, immunosuppressants, or psychotropic medications
- •Hemorrhagic disease, severe diabetes or taking anticoagulant drug
- •Participants who took NSAIDs or pharmacopuncture within 1 week
- •Pregnant or lactating women
- •Participants who had undergone lumbar surgery within 3 months
- •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
Outcomes
Primary Outcomes
Numeric rating scale (NRS) of low-back pain
Time Frame: week 6
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
Secondary Outcomes
- Visual analogue scale (VAS) of leg radiating pain(week 1, 2, 3, 4, 5, 6, 13, 25)
- Short Form-12 Health Survey version 2 (SF-12 v2)(week 1, 6, 13, 25)
- Korean version of the Roland-Morris Disability Questionnaire (RMDQ)(week 1, 6, 13, 25)
- Numeric rating scale (NRS) of low-back pain(week 1, 2, 3, 4, 5, 6, 13, 25)
- Oswestry Disability Index (ODI)(week 1, 6, 13, 25)
- Patient Global Impression of Change (PGIC)(week 6, 13, 25)
- Numeric rating scale (NRS) of radiating pain in lower extremities(week 1, 2, 3, 4, 5, 6, 13, 25)
- EuroQol-5 Dimension (EQ-5D-5L)(week 1, 6, 13, 25)
- Visual analogue scale (VAS) of low-back pain(week 1, 2, 3, 4, 5, 6, 13, 25)