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Bee Venom Acupuncture for the Treatment of Chronic Low Back Pain

Primary Purpose

Chronic Low Back Pain

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

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring chronic low back pain, bee venom acupuncture

Eligibility Criteria

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

Inclusion Criteria:

  • nonspecific, chronic low back pain over 3 months
  • Must have LBP of more than VAS 4

Exclusion Criteria:

  • cancer, vertebral fracture, spinal infection, inflammatory spondylitis
  • spinal operation
  • radicular pain
  • other musculoskeletal pain
  • physicological or mental disorders
  • allergic history to BV therapy or insect bite

Sites / Locations

  • Spine Center, Kyung Hee University Hospital at GangdongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bee Venom Acupuncture & Loxoprofen

Sham Bee Venom Acupuncture & Loxoprofen

Arm Description

Outcomes

Primary Outcome Measures

Visual Analogue Scale for bothersomeness

Secondary Outcome Measures

Visual Analogue Scale for pain intensity
Disability scores on Oswestry Disability Index
Quality of Life scores on EQ-5D
Depression scores on Beck Depression Inventory

Full Information

First Posted
December 7, 2011
Last Updated
March 20, 2012
Sponsor
Kyunghee University Medical Center
Collaborators
Kyung Hee University Hospital at Gangdong
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1. Study Identification

Unique Protocol Identification Number
NCT01491321
Brief Title
Bee Venom Acupuncture for the Treatment of Chronic Low Back Pain
Official Title
Clinical Trial to Evaluate the Efficacy of Bee Venom Acupuncture on Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of bee venom acupuncture on pain intensity, functional status and quality of life of patients with chronic low back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
chronic low back pain, bee venom acupuncture

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Bee Venom Acupuncture & Loxoprofen
Arm Type
Experimental
Arm Title
Sham Bee Venom Acupuncture & Loxoprofen
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Bee Venom Acupuncture Therapy
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, 2days/week 2nd week : SC 0.4cc/day, 2days/week 3rd week : SC 0.8cc/day, 2days/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
Intervention Type
Procedure
Intervention Name(s)
Placebo
Intervention Description
Normal Saline (0.9% NaCl) under NS Increment Protocol Increment Protocol as 1st week : SC 0.2cc/day, 2days/week 2nd week : SC 0.4cc/day, 2days/week 3rd week : SC 0.8cc/day, 2days/week
Primary Outcome Measure Information:
Title
Visual Analogue Scale for bothersomeness
Time Frame
Changes from baseline in VAS at 1 month
Secondary Outcome Measure Information:
Title
Visual Analogue Scale for pain intensity
Time Frame
Changes from baseline in VAS at 1 month
Title
Disability scores on Oswestry Disability Index
Time Frame
Changes from baseline in ODI at 1 month
Title
Quality of Life scores on EQ-5D
Time Frame
Changes from baseline in EQ-5D at 1 month
Title
Depression scores on Beck Depression Inventory
Time Frame
Changes from baseline in BDI at 1 month

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: nonspecific, chronic low back pain over 3 months Must have LBP of more than VAS 4 Exclusion Criteria: cancer, vertebral fracture, spinal infection, inflammatory spondylitis spinal operation radicular pain other musculoskeletal pain physicological or mental disorders allergic history to BV therapy or insect bite
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Byung-Kwan Seo
Phone
82-2-440-7482
Email
seohbk@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun-Hwan Lee
Organizational Affiliation
Spine Center, Kyung Hee University Hospital at Gangdong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Byung-Kwan Seo
Organizational Affiliation
Spine Center, Kyung Hee University Hospital at Gangdong
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dae-Jin Cho
Organizational Affiliation
Spine Center, Kyung Hee University Hospital at Gangdong
Official's Role
Study Director
Facility Information:
Facility Name
Spine Center, Kyung Hee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
134-727
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byung-Kwan Seo
Email
seohbk@hanmail.net
First Name & Middle Initial & Last Name & Degree
Yoon-Su Park
Phone
82-2-440-7482

12. IPD Sharing Statement

Citations:
PubMed Identifier
23317340
Citation
Seo BK, Lee JH, Sung WS, Song EM, Jo DJ. Bee venom acupuncture for the treatment of chronic low back pain: study protocol for a randomized, double-blinded, sham-controlled trial. Trials. 2013 Jan 14;14:16. doi: 10.1186/1745-6215-14-16.
Results Reference
derived

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Bee Venom Acupuncture for the Treatment of Chronic Low Back Pain

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