Whiplash Associated Disorder (WAD)Phase 2NCT01395511
Acupuncture for Whiplash Associated Disorder
A Phase 2 study testing Acupuncture in people with Whiplash Associated Disorder (WAD), run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether acupuncture is effective and safe therapeutic method in the treatment of cervical pain, shoulder and upper extremity pain and discomfort due to Whiplash associated disorder. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Whiplash Associated Disorder (WAD)
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to Oct 2010
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients who suffer cervical pain, limitation of cervical ROM, discomfort sensation due to traffic accidents (Whiplash associated disorder)
- The patients who had no effect with 3 months orthopedical treatment.
- willing to give their permission approval.
- patients of at least 20 years of age (Both men, women)
Who cannot join
- Cervical fracture
- Cervical spondylosis
- suspect malignant disease(ex. tumor, stroke, etc)
- suspect hemorrhagic disease infection disease, inflammatory disease
- unable to communicate with Korean
- The patients who had conscious disorder
- Any other conditions deemed unsuitable for trial as evaluated by Physician-in-charge.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center
Seoul, Hoegi-dong, Dongdaemun-gu, Seoul, 130-702
About this study
Official title: Acupuncture for Whiplash Associated Disorder: a Randomised, Waiting-list Controlled, Open-label, Parallel-group Pilot Trial
The purpose of this study is to determine whether acupuncture is effective and safe therapeutic method in the treatment of cervical pain, shoulder and upper extremity pain and discomfort due to Whiplash associated disorder. (Traumatic car accidents)
We recruit 40 participants who had cervical, shoulder and upper extremity pain and had discomfort due to Whiplash associated disorder. And then we check initial data of 40 participants (Pain;VAS, Cervical ROM, SF-36, SDS, CMI)
Read more
40 participants were randomly allocated to two groups ; acupuncture group or waiting-list group.
Acupuncture group: participants were given acupuncture treatment three times a week during 2 weeks, for 15 minutes at each session. After 6 times acupuncture treatments, we check information of participants again after 2 weeks(VAS, ROM, SF-36, SDS, CMI)
Waiting-list group : The waiting-list group did not receive acupuncture treatment. After 2 weeks we check information of participants again (VAS, ROM, SF-36, SDS, CMI)
The waiting-Patients in both groups were permitted to receive usual care including physical therapy and exercise and were not permitted to take analgesics and antiphlogistics during the trial periods.
Read the detailed description
We recruited participants through advertisements in local newspapers or on the homepage of a Kyung-hee Medical Centre during December 8, 2009 to October 14, 2010.
Patients who met eligibility criteria were randomly allocated into either acupuncture treatment group or waiting-list group. Random sequences were generated by computerized number table. Allocation was concealed using sealed envelopes. According to priority, sealed envelope was matched when the patients had given informed consent.
The method of acupuncture: participants were given acupuncture treatment three times a week during 2 weeks, for 15 minutes (Needle retention time) at each session. (Total 6 times)
We select about ten acupuncture points
- Local Acupoints : SI14, SI15, BL10, BL12, BL13, BL14, TE15, GB20, SI9
- Distal Acupoints :
- Upper extremities: LU6, LU7, LU9, LI11, HT3, SI2, SI3, SI5, SI7, PC4, PC6, TE5
- Lower extremities: SP3, SP4, BL59, BL60, BL61, BL62, BL66, KI3, KI4,KI6, KI7, GB40, GB41, LR4
All Acupuncture points were prepared with 70% alcohol pads, and disposable stainless steel needles were used. Most of acupuncture were inserted vertically 1~2cm in depth until patient can feel De-Qi. (No more additional stimulation)
- Conditions
- Whiplash Associated Disorder (WAD)
- Being tested
- Acupuncture
- Keywords
- whiplash associated disorder,, Intractable Traumatic Cervical Syndrome,, Acupuncture,, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Also called SEIRIN J-Type
Tool : Acupuncture Seirin SJ 0.16 * 40 (mm) / SJ 0.18 * 50 (mm) L-type needles were used for the study.
Made from stainless steel needle SEIRIN JAPAN
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | About ten acupuncture points are selected from the following points to be used. Local Acupoints : SI14, SI15, BL10, BL12, BL13, BL14, TE15, GB20, SI9
Distal Acupoints :
* Upper extremities: LU6, LU7, LU9, LI11, HT3, SI2, SI3, SI5, SI7, PC4, PC6, TE5
* Lower extremities: SP3, SP4, BL59, BL60, BL61, BL62, BL66, KI3, KI4,KI6, KI7, GB40, GB41, LR4
All Acupuncture points were prepared with 70% alcohol pads, and disposable stainless steel needles were used. Most of acupuncture were inserted vertically 1~1.5cm in depth until patient can feel De-Qi. (No more additional stimulation) Receives: Device: Acupuncture |
| Waiting list group | No intervention | No Intervention Comparator The waiting-list group did not receive acupuncture treatment and participants were permitted to receive usual care including physical therapy and exercise and were not permitted to take analgesics and antiphlogistics during the periods. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores on the Visual Analog Scale
VAS which assessed the cervical and back pain intensity used a 0 to 10 point line, which zero corresponded to no pain and 10 to the extreme pain
Measured: Change from Baseline in VAS at 2 weeks (post treatment)
Secondary outcomes (4)
Cervical mobility on the Cervical ROM
Cervical ROM was measured in six directions (Flexion, Extension, Right lateral bending, Left lateral bending, Right rotation, Left rotation) with goniometer.
Measured: Change from Baseline in cervical ROM at 2 weeks (post treatment)
Quality of life on the SF-36(36-Item Short-Form Health Survey)
SF-36, which assessed the quality of life, is composed of eight dimensions. Each dimension stands for Physical Functioning (PF), Social Functioning (SF), Role-Physical (RP), Bodily Pain (BP), Role-Emotional (RE), Mental Health (MH), Vitality (VT), General Health (GH)
Measured: Change from Baseline in SF-36 at 2 weeks (post treatment)
SDS (Zung Self Rating Depression Scale)
SDS, the brief psychology examination consists of 20 questions, which each question has a 4-point rating scale (1 to 4) and sum score was multiplied 1.25 then total score varied from 25 to 100
Measured: Change from Baseline in SDS at 2 weeks (post treatment)
CMI (Cornell Medical Index)
CMI, the brief psychology examination consists of eighteen section-195 questions. A to L section (144 questions) stands for physical state and M to R section (51 questions) stands for mental state. Answer 'yes' means that had a symptom and scores 2 point, and answer 'no' means that had not a symptom and score 1 point
Measured: Change from Baseline in CMI at 2 weeks (post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startDec 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whiplash Associated Disorder (WAD)Studies 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tsukuba
- Investigators
- Do Young Choi, Professor, Principal investigator, Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395511
- Sponsor's protocol ID
- KOMC MIRB2009-05
- Status last verified
- Dec 2009
- First submitted
- 14 Jul 2011
- Last updated
- 15 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Whiplash Associated Disorder: a Randomised, Waiting-list Controlled, Open-label, Parallel-group Pilot Trial
- ClinicalTrials.gov ID
- NCT01395511
- Acronym / sponsor ID
- KOMC MIRB2009-05
- Conditions
- Whiplash Associated Disorder (WAD)
- Keywords
- whiplash associated disorder,, Intractable Traumatic Cervical Syndrome,, Acupuncture,, Randomized controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Collaborators
- University of Tsukuba
- Study start
- Dec 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 15 Jul 2011 (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 determine whether acupuncture is effective and safe therapeutic method in the treatment of cervical pain, shoulder and upper extremity pain and discomfort due to Whiplash associated disorder. (Traumatic car accidents)
We recruit 40 participants who had cervical, shoulder and upper extremity pain and had discomfort due to Whiplash associated disorder. And then we check initial data of 40 participants (Pain;VAS, Cervical ROM, SF-36, SDS, CMI)
40 participants were randomly allocated to two groups ; acupuncture group or waiting-list group.
Acupuncture group: participants were given acupuncture treatment three times a week during 2 weeks, for 15 minutes at each session. After 6 times acupuncture treatments, we check information of participants again after 2 weeks(VAS, ROM, SF-36, SDS, CMI)
Waiting-list group : The waiting-list group did not receive acupuncture treatment. After 2 weeks we check information of participants again (VAS, ROM, SF-36, SDS, CMI)
The waiting-Patients in both groups were permitted to receive usual care including physical therapy and exercise and were not permitted to take analgesics and antiphlogistics during the trial periods.
Detailed description
We recruited participants through advertisements in local newspapers or on the homepage of a Kyung-hee Medical Centre during December 8, 2009 to October 14, 2010.
Patients who met eligibility criteria were randomly allocated into either acupuncture treatment group or waiting-list group. Random sequences were generated by computerized number table. Allocation was concealed using sealed envelopes. According to priority, sealed envelope was matched when the patients had given informed consent.
The method of acupuncture: participants were given acupuncture treatment three times a week during 2 weeks, for 15 minutes (Needle retention time) at each session. (Total 6 times)
We select about ten acupuncture points
- Local Acupoints : SI14, SI15, BL10, BL12, BL13, BL14, TE15, GB20, SI9
- Distal Acupoints :
- Upper extremities: LU6, LU7, LU9, LI11, HT3, SI2, SI3, SI5, SI7, PC4, PC6, TE5
- Lower extremities: SP3, SP4, BL59, BL60, BL61, BL62, BL66, KI3, KI4,KI6, KI7, GB40, GB41, LR4
All Acupuncture points were prepared with 70% alcohol pads, and disposable stainless steel needles were used. Most of acupuncture were inserted vertically 1~2cm in depth until patient can feel De-Qi. (No more additional stimulation)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Device: AcupunctureAbout ten acupuncture points are selected from the following points to be used. Local Acupoints : SI14, SI15, BL10, BL12, BL13, BL14, TE15, GB20, SI9 Distal Acupoints : * Upper extremities: LU6, LU7, LU9, LI11, HT3, SI2, SI3, SI5, SI7, PC4, PC6, TE5 * Lower extremities: SP3, SP4, BL59, BL60, BL61, BL62, BL66, KI3, KI4,KI6, KI7, GB40, GB41, LR4 All Acupuncture points were prepared with 70% alcohol pads, and disposable stainless steel needles were used. Most of acupuncture were inserted vertically 1~1.5cm in depth until patient can feel De-Qi. (No more additional stimulation) |
| Waiting list group | No intervention | –No Intervention Comparator The waiting-list group did not receive acupuncture treatment and participants were permitted to receive usual care including physical therapy and exercise and were not permitted to take analgesics and antiphlogistics during the periods. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patients who suffer cervical pain, limitation of cervical ROM, discomfort sensation due to traffic accidents (Whiplash associated disorder)
- The patients who had no effect with 3 months orthopedical treatment.
- willing to give their permission approval.
- patients of at least 20 years of age (Both men, women)
Key exclusion criteria (7 listed)
- Cervical fracture
- Cervical spondylosis
- suspect malignant disease(ex. tumor, stroke, etc)
- suspect hemorrhagic disease infection disease, inflammatory disease
- unable to communicate with Korean
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: SEIRIN J-TypeTool : Acupuncture Seirin SJ 0.16 * 40 (mm) / SJ 0.18 * 50 (mm) L-type needles were used for the study. Made from stainless steel needle SEIRIN JAPAN | Device | Acupuncture |
Primary outcome
Pain Scores on the Visual Analog Scale
Time frame: Change from Baseline in VAS at 2 weeks (post treatment)
VAS which assessed the cervical and back pain intensity used a 0 to 10 point line, which zero corresponded to no pain and 10 to the extreme pain
4 secondary outcomes
Cervical mobility on the Cervical ROM
Time frame: Change from Baseline in cervical ROM at 2 weeks (post treatment)
Quality of life on the SF-36(36-Item Short-Form Health Survey)
Time frame: Change from Baseline in SF-36 at 2 weeks (post treatment)
SDS (Zung Self Rating Depression Scale)
Time frame: Change from Baseline in SDS at 2 weeks (post treatment)
CMI (Cornell Medical Index)
Time frame: Change from Baseline in CMI at 2 weeks (post treatment)
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 15 Jul 2011.
Related trials for Whiplash Associated Disorder (WAD)
Recruiting
Transauricular Vagus Nerve Stimulation for Chronic Whiplash Associated Disorders
Whiplash Associated Disorder (WAD)
Recruiting
Manipulation and Dry Needling in Patients With Cervicogenic Headache and WAD II
Cervicogenic Headache, Whiplash Injuries
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.
Do Young Choi, Professor principal investigator
Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center.
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 Acupuncture in people with Whiplash Associated Disorder (WAD), 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 4 inclusion and 7 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 15 Jul 2011. 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?
Pain Scores on the Visual Analog Scale (time frame: Change from Baseline in VAS at 2 weeks (post treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2011.