Chronic Non-specific, Uncomplicated Neck Pain
Conditions
Keywords
chronic neck pain, combined treatment between conventional and complementary alternative medical treatment, bee venom acupuncture, NSAIDs
Brief summary
The purpose of this study is to evaluate the efficacy and safety of east-west collaborative treatment using bee venom acupuncture and NSAIDs on pain intensity, functional status and quality of life of patients with chronic cervicalgia
Interventions
PROCEDUREBee Venom Acupuncture
Bee Venom 1:20,000 under BVA Increment Protocol \- Increment Protocol as * 1st week - SC 0.2cc/day, 2 days/week * 2nd week - SC 0.4cc/day, 2 days/week * 3nd week - SC 0.8cc/day, 2 days/week
DRUGLoxoprofen
60 mg/Tab, pers os 1Tab tid, for 3 weeks
Sponsors
Kyung Hee University Hospital at Gangdong
Kyunghee University
Korea Institute of Oriental Medicine
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
* age between 18 and 65 years * nonspecific, uncomplicated, chronic neck pain over 3 months * volunteer can read and write in Korean, providing written informed consent
Exclusion criteria
* exhibited abnormalities on neurological examination * radicular pain * serious spinal disorders including malignancy, vertebral fracture, spinal infection or inflammatory spondylitis * other chronic diseases that could affect or interfere with the therapeutic outcomes including cardiovascular disease, diabetic neuropathy, active hepatitis, fibromyalgia, rheumatoid arthritis, dementia or epilepsy * previous spinal surgery or scheduled procedures during the study * painful conditions induced by traffic accidents * a substantial musculoskeletal problem generating pain from an area other than the neck * conditions for which administration of BVA might not be safe including clotting disorders, administration of an anticoagulant agent, pregnancy and seizure disorders * a documented hypersensitive reaction to previous BVA treatments, bee stings or insect bites * positive reaction observed during a skin hypersensitivity test * severe psychiatric or psychological disorders * current use of corticosteroids, narcotics, muscle relaxants or herbal medicines to treat neck pain or any medication considered inappropriate by the investigator * pending lawsuits or receipt of compensation due to neck pain.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale for bothersomeness | Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neck Disability Index | Changes from baseline in NDI at 2nd, 3rd, 4th and 8th week follow-up | — |
| Depression scores on Beck's Depression Inventory | Changes from baseline in BDI at 4th and 8th week follow-up | — |
| Quality of Life scores on EQ-5D | Changes from baseline in EQ-5D at 2nd, 3rd, 4th and 8th week follow-up | — |
| Visual Analogue Scale for pain intensity | Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up | — |
| Safety profile | At every visit, up to 2 months | Any adverse events must be documented and reported. |
| Credibility test | Changes from baseline in credibility test at 4th week follow-up | — |
| Quality of Life scores on SF-36 | Changes from baseline in SF-36 at 4th and 8th week follow-up | — |
Other
| Measure | Time frame |
|---|---|
| Skin Roll Test | Changes from baseline in skinfold thickness and pressure algometer scores at 4th and 8th week follow-up |
Countries
South Korea
Outcome results
None listed