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

Kyung Hee University

Status and phase: Completed; Phase 2

Conditions: Chronic Non-specific, Uncomplicated Neck Pain

Treatments: Procedure: Bee Venom Acupuncture; Drug: Loxoprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT01922466

KHNMC-OH-IRB 2012-019

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Bee Venom Acupuncture

Experimental group

Treatment:

Procedure: Bee Venom Acupuncture

Loxoprofen

Experimental group

Treatment:

Drug: Loxoprofen

EWCT : Bee Venom Acupucture and Loxoprofen

Experimental group

Treatment:

Procedure: Bee Venom Acupuncture

Drug: Loxoprofen