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

NCT01922466 — Phase 2, Completed, 60 participants, Kyunghee University Medical Center

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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

Registry	NCT01922466
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	60 (Estimated)
Sponsor	Kyunghee University Medical Center (Other); collaborators: Kyung Hee University Hospital at Gangdong, Kyunghee University, Korea Institute of Oriental Medicine
Conditions	Chronic Non-specific, Uncomplicated Neck Pain
Interventions	Bee Venom Acupuncture, Loxoprofen (Procedure, drug)
Dates	start 2013-07-01, primary completion 2014-03-01, completion 2014-07-01, first posted 2013-08-14, last updated 2015-11-24
Locations	1 site in South Korea

-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

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+Arms and interventions

Arm	Type	Interventions
Bee Venom Acupuncture	Experimental	Procedure: Bee Venom Acupuncture
Loxoprofen	Experimental	Drug: Loxoprofen
EWCT : Bee Venom Acupucture and Loxoprofen	Experimental	Procedure: Bee Venom Acupuncture; Drug: Loxoprofen

Bee Venom Acupuncture (Procedure), also known as pharmacopuncture: 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
Loxoprofen (Drug), also known as Loxonin: 60 mg/Tab, pers os 1Tab tid, for 3 weeks

+Outcome measures

Primary outcomes

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

Secondary outcomes

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 [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]

Other outcomes

Skin Roll Test [Changes from baseline in skinfold thickness and pressure algometer scores at 4th and 8th week follow-up]

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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.

+Locations (1)

Facility	City	Country	Status
Spine Center, Kyung Hee University Hospital at Gangdong	Seoul	South Korea

+Publications

Results publication: 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. PMID 24746224

+Investigators

Byung-Kwan Seo, PhD., KMD, Principal investigator, Kyunghee University