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Bee Venom Acupuncture for the Treatment of Chronic Low Back Pain

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Kyunghee University Medical Center.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Kyung Hee University Hospital at Gangdong
Information provided by (Responsible Party):
JLee, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01491321
First received: December 7, 2011
Last updated: March 20, 2012
Last verified: March 2012
  Purpose
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.

Condition Intervention Phase
Chronic Low Back Pain
Procedure: Bee Venom Acupuncture Therapy
Drug: Loxoprofen
Procedure: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate the Efficacy of Bee Venom Acupuncture on Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • Visual Analogue Scale for bothersomeness [ Time Frame: Changes from baseline in VAS at 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual Analogue Scale for pain intensity [ Time Frame: Changes from baseline in VAS at 1 month ] [ Designated as safety issue: No ]
  • Disability scores on Oswestry Disability Index [ Time Frame: Changes from baseline in ODI at 1 month ] [ Designated as safety issue: No ]
  • Quality of Life scores on EQ-5D [ Time Frame: Changes from baseline in EQ-5D at 1 month ] [ Designated as safety issue: No ]
  • Depression scores on Beck Depression Inventory [ Time Frame: Changes from baseline in BDI at 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: April 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: pharmacopuncture
Drug: Loxoprofen
60 mg/Tab, pers os 1Tab tid, for 3 weeks
Other Name: Loxonin
Placebo Comparator: Sham Bee Venom Acupuncture & Loxoprofen Drug: Loxoprofen
60 mg/Tab, pers os 1Tab tid, for 3 weeks
Other Name: 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491321

Locations
Korea, Republic of
Spine Center, Kyung Hee University Hospital at Gangdong
Seoul, Korea, Republic of, 134-727
Sponsors and Collaborators
Kyunghee University Medical Center
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: JLee, Clinical Assistant Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01491321     History of Changes
Other Study ID Numbers: KHNMC-OH-IRB 2011-006 
Study First Received: December 7, 2011
Last Updated: March 20, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Kyunghee University Medical Center:
chronic low back pain
bee venom acupuncture

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Loxoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on December 05, 2016