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

Sponsor

Kyunghee University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01922466

Collaborator

Kyung Hee University Hospital at Gangdong (Other), Kyunghee University (Other), Korea Institute of Oriental Medicine (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Non-specific, Uncomplicated Neck Pain	Procedure: Bee Venom Acupuncture Drug: Loxoprofen	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bee Venom Acupuncture	Procedure: Bee Venom Acupuncture 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 Other Names: pharmacopuncture
Experimental: Loxoprofen	Drug: Loxoprofen 60 mg/Tab, pers os 1Tab tid, for 3 weeks Other Names: Loxonin
Experimental: EWCT : Bee Venom Acupucture and Loxoprofen	Procedure: Bee Venom Acupuncture 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 Other Names: pharmacopuncture Drug: Loxoprofen 60 mg/Tab, pers os 1Tab tid, for 3 weeks Other Names: Loxonin

Arm

Intervention/Treatment

Experimental: Bee Venom Acupuncture

Procedure: Bee Venom Acupuncture

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

Other Names:

pharmacopuncture

Experimental: Loxoprofen

Drug: Loxoprofen

60 mg/Tab, pers os 1Tab tid, for 3 weeks

Other Names:

Loxonin

Experimental: EWCT : Bee Venom Acupucture and Loxoprofen

Procedure: Bee Venom Acupuncture

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

Other Names:

pharmacopuncture

Drug: Loxoprofen

60 mg/Tab, pers os 1Tab tid, for 3 weeks

Other Names:

Loxonin

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.