Chronic Non-specific, Uncomplicated Neck PainPhase 2NCT01922466
East-West Collaboration Treatment Using Bee Venom Acupuncture and NSAIDs for Chronic Cervicalgia
A Phase 2 study testing Bee Venom Acupuncture and Loxoprofen in people with Chronic Non-specific, Uncomplicated Neck Pain, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Non-specific, Uncomplicated Neck Pain
- What is being tested?
- Bee Venom Acupuncture and Loxoprofen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Jul 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Spine Center, Kyung Hee University Hospital at Gangdong
Seoul, 134-727
About this study
Official title: 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
- Being tested
- Bee Venom Acupuncture, Loxoprofen
- Keywords
- chronic neck pain, combined treatment between conventional and complementary alternative medical treatment, bee venom acupuncture, NSAIDs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bee Venom AcupunctureProcedure or surgery
Also called pharmacopuncture
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
LoxoprofenDrug
Also called Loxonin
60 mg/Tab, pers os 1Tab tid, for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bee Venom Acupuncture | Experimental | Not described Receives: Procedure: Bee Venom Acupuncture |
| Loxoprofen | Experimental | Not described Receives: Drug: Loxoprofen |
| EWCT : Bee Venom Acupucture and Loxoprofen | Experimental | Not described Receives: Procedure: Bee Venom Acupuncture; Drug: Loxoprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale for bothersomeness
Measured: Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up
Secondary outcomes (7)
Neck Disability Index
Measured: Changes from baseline in NDI at 2nd, 3rd, 4th and 8th week follow-up
Depression scores on Beck's Depression Inventory
Measured: Changes from baseline in BDI at 4th and 8th week follow-up
Quality of Life scores on EQ-5D
Measured: Changes from baseline in EQ-5D at 2nd, 3rd, 4th and 8th week follow-up
Quality of Life scores on SF-36
Measured: Changes from baseline in SF-36 at 4th and 8th week follow-up
Visual Analogue Scale for pain intensity
Measured: 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.
Measured: At every visit, up to 2 months
Credibility test
Measured: Changes from baseline in credibility test at 4th week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Non-specific, Uncomplicated Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kyung Hee University Hospital at Gangdong, Kyunghee University, Korea Institute of Oriental Medicine
- Responsible party
- Principal investigator, Byung-Kwan Seo, Kyunghee University Medical Center
- Investigators
- Byung-Kwan Seo, PhD., KMD, Principal investigator, Kyunghee University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922466
- Sponsor's protocol ID
- KHNMC-OH-IRB 2012-019
- Status last verified
- Nov 2015
- First submitted
- 8 Aug 2013
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24746224
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01922466
- Acronym / sponsor ID
- KHNMC-OH-IRB 2012-019
- Keywords
- chronic neck pain, combined treatment between conventional and complementary alternative medical treatment, bee venom acupuncture, NSAIDs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Collaborators
- Kyung Hee University Hospital at Gangdong, Kyunghee University, Korea Institute of Oriental Medicine
- Study start
- Jul 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 14 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bee Venom Acupuncture | Experimental | Procedure: Bee Venom Acupuncture |
| Loxoprofen | Experimental | Drug: Loxoprofen |
| EWCT : Bee Venom Acupucture and Loxoprofen | Experimental | Procedure: Bee Venom Acupuncture, Drug: Loxoprofen |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bee Venom AcupunctureAlso: pharmacopunctureBee 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 | Procedure or surgery | Bee Venom Acupuncture, EWCT : Bee Venom Acupucture and Loxoprofen |
| LoxoprofenAlso: Loxonin60 mg/Tab, pers os 1Tab tid, for 3 weeks | Drug | EWCT : Bee Venom Acupucture and Loxoprofen, Loxoprofen |
Primary outcome
Visual Analogue Scale for bothersomeness
Time frame: Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up
7 secondary outcomes
Neck Disability Index
Time frame: Changes from baseline in NDI at 2nd, 3rd, 4th and 8th week follow-up
Depression scores on Beck's Depression Inventory
Time frame: Changes from baseline in BDI at 4th and 8th week follow-up
Quality of Life scores on EQ-5D
Time frame: Changes from baseline in EQ-5D at 2nd, 3rd, 4th and 8th week follow-up
Quality of Life scores on SF-36
Time frame: Changes from baseline in SF-36 at 4th and 8th week follow-up
Visual Analogue Scale for pain intensity
Time frame: Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up
Safety profile
Time frame: At every visit, up to 2 months
Credibility test
Time frame: Changes from baseline in credibility test at 4th week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
- Derived from this study: PubMed 24746224Seo 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byung-Kwan Seo, PhD., KMD principal investigator
Kyunghee University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bee Venom Acupuncture and Loxoprofen in people with Chronic Non-specific, Uncomplicated Neck Pain, run by Kyunghee University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale for bothersomeness (time frame: Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01922466, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2015.