Chronic Neck PainNCT01205958
The Effect of East-West Collaborative Medicine on Chronic Cervical Pain
A study testing acupuncture in people with Chronic Neck Pain, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to assess the effect of East-West collaborative medicine on chronic cervical pain. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to Feb 2011
- Phase
- Interventional
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- presence of Chronic neck pain
Who cannot join
- Cancer
- Spinal infection
- ankylosing spondylosis
- myelopathy
- moderate hypertension or more
- serious mental disease
- other skeletomuscular disease
- history of operation or acupuncture treatment about spinal disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyunghee University East West Neo Medical Center
Seoul, 134-727
JaeHeung Cho, OMD, +82-2-440-7581, vetkong95@hanmail.net
About this study
Official title: Clinical Trial to Evaluate the Effect of East-West Collaborative Medicine on Chronic Cervical Pain: a Pilot Study
The purpose of this study is to assess the effect of East-West collaborative medicine on chronic cervical pain.
Read the detailed description
Design: This is a randomized, controlled study.
Participants: 45 participants with chronic cervical pain are recruited and randomly assigned to three groups.
Intervention: Over an three-week period, one group(n=15) gets western medicine treatment(drug medication); another group(n=15) gets oriental medicine treatment(individualized needling 2-3 times a week); the other group(n=15) gets western medicine plus oriental medicine treatment for 3 weeks
- Conditions
- Chronic Neck Pain
- Being tested
- acupuncture
- Keywords
- Cervical pain, Neck pain, western medicine, oriental medicine, acupuncture, needle
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
Also called Zaltoprofen
Over an three-week period, one group(n=15) gets western medicine treatment(drug medication); another group(n=15) gets oriental medicine treatment(individualized needling 2-3 times a week); the other group(n=15) gets western medicine plus oriental medicine treatment for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| medication(Zaltoprofen) | Active comparator | Not described Receives: Procedure: acupuncture |
| Acupuncture | Active comparator | Not described Receives: Procedure: acupuncture |
| Zalprofen plus Acupuncture | Active comparator | Not described Receives: Procedure: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores on the Visual Analogue Scale(VAS)
Measured: 7 week
Secondary outcomes (4)
Neck disability index
Neck disability index : questionnaire for measuring how much neck pain affects ability of daily activities
Measured: 7 week
Beck depression inventory
Beck depression inventory : for assessing depression
Measured: 7 week
SF-36
questionnaire for measuring health-related quality of life
Measured: 7 week
EQ-5D(EuroQol-5 dimension)
questionnaire for measuring health-related quality of life
Measured: 7 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study startDec 2009
- Primary completionJan 2011 (estimated)
- Study completionFeb 2011 (estimated)
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 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jun-Hwan Lee, OMD, PhD, Principal investigator, Department of Oriental Rehabilitation Medicine/College of Oriental Medicine/Kyung Hee University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205958
- Sponsor's protocol ID
- KHU 20091458
- Status last verified
- Sep 2010
- First submitted
- 14 Sep 2010
- Last updated
- 21 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cho JH, Nam DH, Kim KT, Lee JH. Acupuncture with non-steroidal anti-inflammatory drugs (NSAIDs) versus acupuncture or NSAIDs alone for the treatment of chronic neck pain: an assessor-blinded randomised controlled pilot study. Acupunct Med. 2014 Feb;32(1):17-23. doi: 10.1136/acupmed-2013-010410. Epub 2013 Oct 30.
PubMed 24171895
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Effect of East-West Collaborative Medicine on Chronic Cervical Pain: a Pilot Study
- ClinicalTrials.gov ID
- NCT01205958
- Acronym / sponsor ID
- KHU 20091458
- Conditions
- Chronic Neck Pain
- Keywords
- Cervical pain, Neck pain, western medicine, oriental medicine, acupuncture, needle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 21 Sep 2010 (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 assess the effect of East-West collaborative medicine on chronic cervical pain.
Detailed description
Design: This is a randomized, controlled study.
Participants: 45 participants with chronic cervical pain are recruited and randomly assigned to three groups.
Intervention: Over an three-week period, one group(n=15) gets western medicine treatment(drug medication); another group(n=15) gets oriental medicine treatment(individualized needling 2-3 times a week); the other group(n=15) gets western medicine plus oriental medicine treatment for 3 weeks
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| medication(Zaltoprofen) | Active comparator | Procedure: acupuncture |
| Acupuncture | Active comparator | Procedure: acupuncture |
| Zalprofen plus Acupuncture | Active comparator | Procedure: acupuncture |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- presence of Chronic neck pain
Key exclusion criteria (8 listed)
- Cancer
- Spinal infection
- ankylosing spondylosis
- myelopathy
- moderate hypertension or more
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 |
|---|---|---|
| acupunctureAlso: ZaltoprofenOver an three-week period, one group(n=15) gets western medicine treatment(drug medication); another group(n=15) gets oriental medicine treatment(individualized needling 2-3 times a week); the other group(n=15) gets western medicine plus oriental medicine treatment for 3 weeks | Procedure or surgery | Acupuncture, Zalprofen plus Acupuncture, medication(Zaltoprofen) |
Primary outcome
Pain Scores on the Visual Analogue Scale(VAS)
Time frame: 7 week
4 secondary outcomes
Neck disability index
Time frame: 7 week
Beck depression inventory
Time frame: 7 week
SF-36
Time frame: 7 week
EQ-5D(EuroQol-5 dimension)
Time frame: 7 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2010.
- Derived from this study: PubMed 24171895Cho JH, Nam DH, Kim KT, Lee JH. Acupuncture with non-steroidal anti-inflammatory drugs (NSAIDs) versus acupuncture or NSAIDs alone for the treatment of chronic neck pain: an assessor-blinded randomised controlled pilot study. Acupunct Med. 2014 Feb;32(1):17-23. doi: 10.1136/acupmed-2013-010410. Epub 2013 Oct 30.
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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.
Jun-Hwan Lee, OMD, PhD principal investigator
Department of Oriental Rehabilitation Medicine/College of Oriental Medicine/Kyung Hee University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Chronic 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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 21 Sep 2010. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Jeong Cho, OMD (+82-2-440-7575, jamyunghwa@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores on the Visual Analogue Scale(VAS) (time frame: 7 week). 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 NCT01205958, 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 21 Sep 2010.