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

Primary Purpose

Chronic Non-specific, Uncomplicated Neck Pain

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bee Venom Acupuncture
Loxoprofen
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Non-specific, Uncomplicated Neck Pain focused on measuring chronic neck pain, combined treatment between conventional and complementary alternative medical treatment, bee venom acupuncture, NSAIDs

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Spine Center, Kyung Hee University Hospital at Gangdong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Bee Venom Acupuncture

Loxoprofen

EWCT : Bee Venom Acupucture and Loxoprofen

Arm Description

Outcomes

Primary Outcome Measures

Visual Analogue Scale for bothersomeness

Secondary Outcome Measures

Neck Disability Index
Depression scores on Beck's Depression Inventory
Quality of Life scores on EQ-5D
Quality of Life scores on SF-36
Visual Analogue Scale for pain intensity
Safety profile
Any adverse events must be documented and reported.
Credibility test

Full Information

First Posted
August 8, 2013
Last Updated
November 20, 2015
Sponsor
Kyunghee University Medical Center
Collaborators
Kyung Hee University Hospital at Gangdong, Kyunghee University, Korea Institute of Oriental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01922466
Brief Title
East-West Collaboration Treatment Using Bee Venom Acupuncture and NSAIDs for Chronic Cervicalgia
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 Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center
Collaborators
Kyung Hee University Hospital at Gangdong, Kyunghee University, Korea Institute of Oriental Medicine

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Non-specific, Uncomplicated Neck Pain
Keywords
chronic neck pain, combined treatment between conventional and complementary alternative medical treatment, bee venom acupuncture, NSAIDs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bee Venom Acupuncture
Arm Type
Experimental
Arm Title
Loxoprofen
Arm Type
Experimental
Arm Title
EWCT : Bee Venom Acupucture and Loxoprofen
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Bee Venom Acupuncture
Other Intervention Name(s)
pharmacopuncture
Intervention Description
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
Drug
Intervention Name(s)
Loxoprofen
Other Intervention Name(s)
Loxonin
Intervention Description
60 mg/Tab, pers os 1Tab tid, for 3 weeks
Primary Outcome Measure Information:
Title
Visual Analogue Scale for bothersomeness
Time Frame
Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up
Secondary Outcome Measure Information:
Title
Neck Disability Index
Time Frame
Changes from baseline in NDI at 2nd, 3rd, 4th and 8th week follow-up
Title
Depression scores on Beck's Depression Inventory
Time Frame
Changes from baseline in BDI at 4th and 8th week follow-up
Title
Quality of Life scores on EQ-5D
Time Frame
Changes from baseline in EQ-5D at 2nd, 3rd, 4th and 8th week follow-up
Title
Quality of Life scores on SF-36
Time Frame
Changes from baseline in SF-36 at 4th and 8th week follow-up
Title
Visual Analogue Scale for pain intensity
Time Frame
Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up
Title
Safety profile
Description
Any adverse events must be documented and reported.
Time Frame
At every visit, up to 2 months
Title
Credibility test
Time Frame
Changes from baseline in credibility test at 4th week follow-up
Other Pre-specified Outcome Measures:
Title
Skin Roll Test
Time Frame
Changes from baseline in skinfold thickness and pressure algometer scores at 4th and 8th week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung-Kwan Seo, PhD., KMD
Organizational Affiliation
Kyunghee University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spine Center, Kyung Hee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
134-727
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
24746224
Citation
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.
Results Reference
derived

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

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