East-West Collaboration Treatment Using Bee Venom Acupuncture and NSAIDs for Chronic Cervicalgia

Clinical Research on the Efficacy and Safety of East-West Collaborative Treatment Using NSAIDs and BV on Chronic Cervical Pain; A Randomized, Controlled, Parallel, Pilot Study

The purpose of this study is to evaluate the efficacy and safety of east-west collaborative treatment using bee venom acupuncture and NSAIDs on pain intensity, functional status and quality of life of patients with chronic cervicalgia

Study Overview

• Status: Completed
• Conditions: Chronic Non-specific, Uncomplicated Neck Pain
• Intervention / Treatment: Drug: Loxoprofen; Procedure: Bee Venom Acupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 134-727
    • Spine Center, Kyung Hee University Hospital at Gangdong

Participation Criteria

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:

• age between 18 and 65 years
• nonspecific, uncomplicated, chronic neck pain over 3 months
• volunteer can read and write in Korean, providing written informed consent

Exclusion Criteria:

• exhibited abnormalities on neurological examination
• radicular pain
• serious spinal disorders including malignancy, vertebral fracture, spinal infection or inflammatory spondylitis
• other chronic diseases that could affect or interfere with the therapeutic outcomes including cardiovascular disease, diabetic neuropathy, active hepatitis, fibromyalgia, rheumatoid arthritis, dementia or epilepsy
• previous spinal surgery or scheduled procedures during the study
• painful conditions induced by traffic accidents
• a substantial musculoskeletal problem generating pain from an area other than the neck
• conditions for which administration of BVA might not be safe including clotting disorders, administration of an anticoagulant agent, pregnancy and seizure disorders
• a documented hypersensitive reaction to previous BVA treatments, bee stings or insect bites
• positive reaction observed during a skin hypersensitivity test
• severe psychiatric or psychological disorders
• current use of corticosteroids, narcotics, muscle relaxants or herbal medicines to treat neck pain or any medication considered inappropriate by the investigator
• pending lawsuits or receipt of compensation due to neck pain.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bee Venom Acupuncture	Procedure: Bee Venom Acupuncture; Bee Venom 1:20,000 under BVA Increment Protocol - Increment Protocol as; 1st week - SC 0.2cc/day, 2 days/week; 2nd week - SC 0.4cc/day, 2 days/week; 3nd week - SC 0.8cc/day, 2 days/week; Other Names: pharmacopuncture
Experimental: Loxoprofen	Drug: Loxoprofen; 60 mg/Tab, pers os 1Tab tid, for 3 weeks; Other Names: Loxonin
Experimental: EWCT : Bee Venom Acupucture and Loxoprofen	Drug: Loxoprofen; 60 mg/Tab, pers os 1Tab tid, for 3 weeks; Other Names: Loxonin; Procedure: Bee Venom Acupuncture; Bee Venom 1:20,000 under BVA Increment Protocol - Increment Protocol as; 1st week - SC 0.2cc/day, 2 days/week; 2nd week - SC 0.4cc/day, 2 days/week; 3nd week - SC 0.8cc/day, 2 days/week; Other Names: pharmacopuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual Analogue Scale for bothersomeness	Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck Disability Index		Changes from baseline in NDI at 2nd, 3rd, 4th and 8th week follow-up
Depression scores on Beck's Depression Inventory		Changes from baseline in BDI at 4th and 8th week follow-up
Quality of Life scores on EQ-5D		Changes from baseline in EQ-5D at 2nd, 3rd, 4th and 8th week follow-up
Quality of Life scores on SF-36		Changes from baseline in SF-36 at 4th and 8th week follow-up
Visual Analogue Scale for pain intensity		Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up
Safety profile	Any adverse events must be documented and reported.	At every visit, up to 2 months
Credibility test		Changes from baseline in credibility test at 4th week follow-up

Other Outcome Measures

Outcome Measure	Time Frame
Skin Roll Test	Changes from baseline in skinfold thickness and pressure algometer scores at 4th and 8th week follow-up

Collaborators and Investigators

• Sponsor: Kyunghee University Medical Center
• Collaborators: Kyung Hee University Hospital at Gangdong; Korea Institute of Oriental Medicine; Kyunghee University
• Investigators: Principal Investigator: Byung-Kwan Seo, PhD., KMD, Kyunghee University

Publications and helpful links

General Publications

• Seo BK, Lee JH, Kim PK, Baek YH, Jo DJ, Lee S. Bee venom acupuncture, NSAIDs or combined treatment for chronic neck pain: study protocol for a randomized, assessor-blind trial. Trials. 2014 Apr 21;15:132. doi: 10.1186/1745-6215-15-132.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: August 8, 2013
• First Submitted That Met QC Criteria: August 11, 2013
• First Posted (Estimate): August 14, 2013

Study Record Updates

• Last Update Posted (Estimate): November 24, 2015
• Last Update Submitted That Met QC Criteria: November 20, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: NSAIDs; chronic neck pain; bee venom acupuncture; combined treatment between conventional and complementary alternative medical treatment
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Loxoprofen
• Other Study ID Numbers: KHNMC-OH-IRB 2012-019