Bee Venom Acupuncture for the Treatment of Chronic Low Back Pain
Clinical Trial to Evaluate the Efficacy of Bee Venom Acupuncture on Chronic Low Back Pain
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 7, 2011
CompletedFirst Posted
Study publicly available on registry
December 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedMarch 21, 2012
March 1, 2012
11 months
December 7, 2011
March 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analogue Scale for bothersomeness
Changes from baseline in VAS at 1 month
Secondary Outcomes (4)
Visual Analogue Scale for pain intensity
Changes from baseline in VAS at 1 month
Disability scores on Oswestry Disability Index
Changes from baseline in ODI at 1 month
Quality of Life scores on EQ-5D
Changes from baseline in EQ-5D at 1 month
Depression scores on Beck Depression Inventory
Changes from baseline in BDI at 1 month
Study Arms (2)
Bee Venom Acupuncture & Loxoprofen
EXPERIMENTALSham Bee Venom Acupuncture & Loxoprofen
PLACEBO COMPARATORInterventions
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
60 mg/Tab, pers os 1Tab tid, for 3 weeks
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
Eligibility Criteria
You may qualify if:
- nonspecific, chronic low back pain over 3 months
- Must have LBP of more than VAS 4
You may not qualify if:
- 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
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
Related Publications (1)
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.
PMID: 23317340DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Jun-Hwan Lee
Spine Center, Kyung Hee University Hospital at Gangdong
- STUDY DIRECTOR
Byung-Kwan Seo
Spine Center, Kyung Hee University Hospital at Gangdong
- STUDY DIRECTOR
Dae-Jin Cho
Spine Center, Kyung Hee University Hospital at Gangdong
Central Study Contacts
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
- Clinical Assistant Professor
Study Record Dates
First Submitted
December 7, 2011
First Posted
December 14, 2011
Study Start
April 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
March 21, 2012
Record last verified: 2012-03