Chronic Low Back Pain
Conditions
Keywords
chronic low back pain, bee venom acupuncture
Brief summary
The purpose of this study is to evaluate the efficacy of bee venom acupuncture on pain intensity, functional status and quality of life of patients with chronic low back pain.
Interventions
PROCEDUREBee Venom Acupuncture Therapy
Bee Venom 1:20,000 under BVA Increment Protocol Increment Protocol as * 1st week : SC 0.2cc/day, 2days/week * 2nd week : SC 0.4cc/day, 2days/week * 3rd week : SC 0.8cc/day, 2days/week
DRUGLoxoprofen
60 mg/Tab, pers os 1Tab tid, for 3 weeks
PROCEDUREPlacebo
Normal Saline (0.9% NaCl) under NS Increment Protocol Increment Protocol as * 1st week : SC 0.2cc/day, 2days/week * 2nd week : SC 0.4cc/day, 2days/week * 3rd week : SC 0.8cc/day, 2days/week
Sponsors
Kyung Hee University Hospital at Gangdong
Kyunghee University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* nonspecific, chronic low back pain over 3 months * Must have LBP of more than VAS 4
Exclusion criteria
* cancer, vertebral fracture, spinal infection, inflammatory spondylitis * spinal operation * radicular pain * other musculoskeletal pain * physicological or mental disorders * allergic history to BV therapy or insect bite
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale for bothersomeness | Changes from baseline in VAS at 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale for pain intensity | Changes from baseline in VAS at 1 month |
| Disability scores on Oswestry Disability Index | Changes from baseline in ODI at 1 month |
| Quality of Life scores on EQ-5D | Changes from baseline in EQ-5D at 1 month |
| Depression scores on Beck Depression Inventory | Changes from baseline in BDI at 1 month |
Countries
South Korea
Contacts
Primary ContactByung-Kwan Seo
Outcome results
None listed