Bee Venom Acupuncture for the Treatment of Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

Clinical Trial to Evaluate the Efficacy of Bee Venom Acupuncture on Chronic Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01491321
• Other study ID #: KHNMC-OH-IRB 2011-006
• Status: Recruiting
• Phase: Phase 2
• First received: December 7, 2011
• Last updated: March 20, 2012
• Start date: April 2011
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Kyunghee University Medical Center
• Contact: Byung-Kwan Seo
• Phone: 82-2-440-7482
• Email: seohbk[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Procedure:
• Bee Venom Acupuncture Therapy
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

Drug:
• Loxoprofen
60 mg/Tab, pers os 1Tab tid, for 3 weeks

Procedure:
• Placebo
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

Locations

Country	Name	City	State
Korea, Republic of	Spine Center, Kyung Hee University Hospital at Gangdong	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Kyunghee University Medical Center	Kyung Hee University Hospital at Gangdong

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale for bothersomeness		Changes from baseline in VAS at 1 month	No
Secondary	Visual Analogue Scale for pain intensity		Changes from baseline in VAS at 1 month	No
Secondary	Disability scores on Oswestry Disability Index		Changes from baseline in ODI at 1 month	No
Secondary	Quality of Life scores on EQ-5D		Changes from baseline in EQ-5D at 1 month	No
Secondary	Depression scores on Beck Depression Inventory		Changes from baseline in BDI at 1 month	No