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Completed

NCT Number: NCT01922466

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

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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Key information

Conditions

Chronic Non-specific, Uncomplicated Neck Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Spine Center, Kyung Hee University Hospital at Gangdong

Seoul, 134-727, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bee Venom Acupuncture

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

Other names: pharmacopuncture

Loxoprofen

Drug

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

Other names: Loxonin

Primary outcomes

  1. Visual Analogue Scale for bothersomeness

    Time frame: Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up

Secondary outcomes

  1. Neck Disability Index

    Time frame: Changes from baseline in NDI at 2nd, 3rd, 4th and 8th week follow-up

  2. Depression scores on Beck's Depression Inventory

    Time frame: Changes from baseline in BDI at 4th and 8th week follow-up

  3. Quality of Life scores on EQ-5D

    Time frame: Changes from baseline in EQ-5D at 2nd, 3rd, 4th and 8th week follow-up

  4. Quality of Life scores on SF-36

    Time frame: Changes from baseline in SF-36 at 4th and 8th week follow-up

  5. Visual Analogue Scale for pain intensity

    Time frame: Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up

  6. Safety profile

    Time frame: At every visit, up to 2 months

    Any adverse events must be documented and reported.

  7. Credibility test

    Time frame: Changes from baseline in credibility test at 4th week follow-up

Other outcomes

  1. Skin Roll Test

    Time frame: Changes from baseline in skinfold thickness and pressure algometer scores at 4th and 8th week follow-up

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Collaborators

  • Korea Institute of Oriental Medicine
  • Kyung Hee University Hospital at Gangdong
  • Kyunghee University

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 14, 2013
Registry last updated
Nov 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.