Bee Venom Acupuncture for the Treatment of Chronic Low Back Pain

NCT ID: NCT01491321

Last Updated: 2012-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bee Venom Acupuncture & Loxoprofen

Group Type EXPERIMENTAL

Bee Venom Acupuncture Therapy

Intervention Type PROCEDURE

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

Loxoprofen

Intervention Type DRUG

60 mg/Tab, pers os 1Tab tid, for 3 weeks

Sham Bee Venom Acupuncture & Loxoprofen

Group Type PLACEBO_COMPARATOR

Loxoprofen

Intervention Type DRUG

60 mg/Tab, pers os 1Tab tid, for 3 weeks

Placebo

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Loxoprofen

60 mg/Tab, pers os 1Tab tid, for 3 weeks

Intervention Type DRUG

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

Intervention Type PROCEDURE

Other Intervention Names

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pharmacopuncture Loxonin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyung Hee University Hospital at Gangdong

OTHER

Sponsor Role collaborator

Kyunghee University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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JLee

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun-Hwan Lee

Role: PRINCIPAL_INVESTIGATOR

Spine Center, Kyung Hee University Hospital at Gangdong

Byung-Kwan Seo

Role: STUDY_DIRECTOR

Spine Center, Kyung Hee University Hospital at Gangdong

Dae-Jin Cho

Role: STUDY_DIRECTOR

Spine Center, Kyung Hee University Hospital at Gangdong

Locations

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Spine Center, Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Byung-Kwan Seo

Role: CONTACT

82-2-440-7482

Facility Contacts

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Byung-Kwan Seo

Role: primary

Yoon-Su Park

Role: backup

82-2-440-7482

References

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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.

Reference Type DERIVED
PMID: 23317340 (View on PubMed)

Other Identifiers

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KHNMC-OH-IRB 2011-006

Identifier Type: -

Identifier Source: org_study_id

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