Bee Venom Acupuncture for the Treatment of Chronic Low Back Pain

March 20, 2012 updated by: JLee, Kyunghee University Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 134-727
        • Recruiting
        • Spine Center, Kyung Hee University Hospital at Gangdong
        • Contact:
        • Contact:
          • Yoon-Su Park
          • Phone Number: 82-2-440-7482

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bee Venom Acupuncture & Loxoprofen
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
Other Names:
  • pharmacopuncture
Drug: Loxoprofen
60 mg/Tab, pers os 1Tab tid, for 3 weeks
Other Names:
  • Loxonin
Placebo Comparator: Sham Bee Venom Acupuncture & Loxoprofen
Drug: Loxoprofen
60 mg/Tab, pers os 1Tab tid, for 3 weeks
Other Names:
  • Loxonin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Analogue Scale for bothersomeness
Time Frame: Changes from baseline in VAS at 1 month
Changes from baseline in VAS at 1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual Analogue Scale for pain intensity
Time Frame: Changes from baseline in VAS at 1 month
Changes from baseline in VAS at 1 month
Disability scores on Oswestry Disability Index
Time Frame: Changes from baseline in ODI at 1 month
Changes from baseline in ODI at 1 month
Quality of Life scores on EQ-5D
Time Frame: Changes from baseline in EQ-5D at 1 month
Changes from baseline in EQ-5D at 1 month
Depression scores on Beck Depression Inventory
Time Frame: Changes from baseline in BDI at 1 month
Changes from baseline in BDI at 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyunghee University Medical Center

Collaborators

Kyung Hee University Hospital at Gangdong

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

December 7, 2011

First Submitted That Met QC Criteria

December 12, 2011

First Posted (Estimate)

December 14, 2011

Study Record Updates

Last Update Posted (Estimate)

March 21, 2012

Last Update Submitted That Met QC Criteria

March 20, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KHNMC-OH-IRB 2011-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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