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

NCT ID: NCT01922466

Last Updated: 2015-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-07-31

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

Detailed Description

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Conditions

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Chronic Non-specific, Uncomplicated Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bee Venom Acupuncture

Group Type EXPERIMENTAL

Bee Venom Acupuncture

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

Loxoprofen

Intervention Type DRUG

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

EWCT : Bee Venom Acupucture and Loxoprofen

Group Type EXPERIMENTAL

Bee Venom Acupuncture

Intervention Type PROCEDURE

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

Intervention Type DRUG

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

Interventions

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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

Intervention Type PROCEDURE

Loxoprofen

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

Intervention Type DRUG

Other Intervention Names

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pharmacopuncture Loxonin

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyung Hee University Hospital at Gangdong

OTHER

Sponsor Role collaborator

Kyunghee University

OTHER

Sponsor Role collaborator

Korea Institute of Oriental Medicine

OTHER_GOV

Sponsor Role collaborator

Kyunghee University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Byung-Kwan Seo

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Byung-Kwan Seo, PhD., KMD

Role: PRINCIPAL_INVESTIGATOR

Kyunghee University

Locations

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Spine Center, Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 24746224 (View on PubMed)

Other Identifiers

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KHNMC-OH-IRB 2012-019

Identifier Type: -

Identifier Source: org_study_id