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

Phase 2

Completed

• Conditions: Chronic Non-specific, Uncomplicated Neck Pain
• Interventions: Procedure: Bee Venom Acupuncture; Drug: Loxoprofen

• Registration Number: NCT01922466
• Lead Sponsor: Kyunghee University Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-08
• Study First Submitted QC: 2013-08-11
• Study First Posted: 2013-08-14
• Primary Completion: 2014-03
• Study Completion: 2014-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-20
• Last Update Posted: 2015-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bee Venom Acupuncture	Bee Venom Acupuncture	-
Loxoprofen	Loxoprofen	-
EWCT : Bee Venom Acupucture and Loxoprofen	Bee Venom Acupuncture	-
EWCT : Bee Venom Acupucture and Loxoprofen	Loxoprofen	-

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale for bothersomeness	Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up

Secondary Outcome Measures

Name	Time	Method
Neck Disability Index	Changes from baseline in NDI at 2nd, 3rd, 4th and 8th week follow-up
Credibility test	Changes from baseline in credibility test at 4th week follow-up
Visual Analogue Scale for pain intensity	Changes from baseline in VAS at 1st, 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
Safety profile	At every visit, up to 2 months	Any adverse events must be documented and reported.
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

Trial Locations

Locations (1)

Spine Center, Kyung Hee University Hospital at Gangdong; 🇰🇷 Seoul, Korea, Republic of