NCT01922466

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

November 24, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

August 8, 2013

Last Update Submit

November 20, 2015

Conditions

Chronic Non-specific, Uncomplicated Neck Pain

Keywords

chronic neck paincombined treatment between conventional and complementary alternative medical treatmentbee venom acupunctureNSAIDs

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale for bothersomeness

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

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Other Outcomes (1)

  • Skin Roll Test

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

Study Arms (3)

Bee Venom Acupuncture

EXPERIMENTAL
Procedure: Bee Venom Acupuncture

Loxoprofen

EXPERIMENTAL
Drug: Loxoprofen

EWCT : Bee Venom Acupucture and Loxoprofen

EXPERIMENTAL
Procedure: Bee Venom AcupunctureDrug: Loxoprofen

Interventions

Bee Venom AcupuncturePROCEDURE

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

Also known as: pharmacopuncture
Bee Venom AcupunctureEWCT : Bee Venom Acupucture and Loxoprofen
LoxoprofenDRUG

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

Also known as: Loxonin
EWCT : Bee Venom Acupucture and LoxoprofenLoxoprofen

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spine Center, Kyung Hee University Hospital at Gangdong

Seoul, 134-727, South Korea

Location

Related Publications (1)

  • 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: 24746224DERIVED

MeSH Terms

Interventions

loxoprofen

Study Officials

  • Byung-Kwan Seo, PhD., KMD

    Kyunghee University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 8, 2013

First Posted

August 14, 2013

Study Start

July 1, 2013

Primary Completion

March 1, 2014

Study Completion

July 1, 2014

Last Updated

November 24, 2015

Record last verified: 2015-11

Locations

KR(1)