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

K

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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