Clinical trial NCT01922466: East-West Collaboration Treatment Using Bee Venom Acupuncture and NSAIDs for Chronic Cervicalgia
Official title: Clinical Research on the Efficacy and Safety of East-West Collaborative Treatment Using NSAIDs and BV on Chronic Cervical Pain; A Randomized, Controlled, Parallel, Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Non-specific, Uncomplicated Neck Pain
Keywords: chronic neck pain
combined treatment between conventional and complementary alternative medical treatment
bee venom acupuncture
NSAIDs
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Kyung Hee University Hospital at Gangdong
name: Kyunghee University
name: Korea Institute of Oriental Medicine
First posted: 2013-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analogue Scale for bothersomeness
timeFrame: Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up
Secondary outcomes:
measure: Neck Disability Index
timeFrame: Changes from baseline in NDI at 2nd, 3rd, 4th and 8th week follow-up
measure: Depression scores on Beck's Depression Inventory
timeFrame: Changes from baseline in BDI at 4th and 8th week follow-up
measure: Quality of Life scores on EQ-5D
timeFrame: Changes from baseline in EQ-5D at 2nd, 3rd, 4th and 8th week follow-up
measure: Quality of Life scores on SF-36
timeFrame: Changes from baseline in SF-36 at 4th and 8th week follow-up
measure: Visual Analogue Scale for pain intensity
timeFrame: Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up
measure: Safety profile
timeFrame: At every visit, up to 2 months
measure: Credibility test
timeFrame: Changes from baseline in credibility test at 4th week follow-up
Other outcomes:
measure: Skin Roll Test
timeFrame: Changes from baseline in skinfold thickness and pressure algometer scores at 4th and 8th week follow-up
Locations:
city: Seoul
country: Korea, Republic of
facility: Spine Center, Kyung Hee University Hospital at Gangdong
Study officials:
affiliation: Kyunghee University
name: Byung-Kwan Seo, PhD., KMD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seo BK, Lee JH, Kim PK, Baek YH, Jo DJ, Lee S. Bee venom acupuncture, NSAIDs or combined treatment for chronic neck pain: study protocol for a randomized, assessor-blind trial. Trials. 2014 Apr 21;15:132. doi: 10.1186/1745-6215-15-132.