East-West Collaboration Treatment Using Bee Venom Acupuncture and NSAIDs for Chronic Cervicalgia

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Chronic Non-specific, Uncomplicated Neck Pain

Intervention / Treatment
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* Procedure: Bee Venom Acupuncture
* Drug: Loxoprofen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bee Venom Acupuncture<br> | Procedure: Bee Venom Acupuncture<br>* 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<br>* Other names: pharmacopuncture;|
| Experimental: Loxoprofen<br> | Drug: Loxoprofen<br>* 60 mg/Tab, pers os 1Tab tid, for 3 weeks<br>* Other names: Loxonin;|
| Experimental: EWCT : Bee Venom Acupucture and Loxoprofen<br> | Procedure: Bee Venom Acupuncture<br>* 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<br>* Other names: pharmacopuncture;Drug: Loxoprofen<br>* 60 mg/Tab, pers os 1Tab tid, for 3 weeks<br>* Other names: Loxonin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale for bothersomeness |  | Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Quality of Life scores on SF-36 |  | Changes from baseline in SF-36 at 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 | Any adverse events must be documented and reported. | At every visit, up to 2 months | 
| Credibility test |  | Changes from baseline in credibility test at 4th week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic neck pain, combined treatment between conventional and complementary alternative medical treatment, bee venom acupuncture, NSAIDs