Acupuncture for Whiplash Associated Disorder
|ClinicalTrials.gov Identifier: NCT01395511|
Recruitment Status : Completed
First Posted : July 15, 2011
Last Update Posted : July 15, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Whiplash Associated Disorder (WAD)||Device: Acupuncture||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acupuncture for Whiplash Associated Disorder: a Randomised, Waiting-list Controlled, Open-label, Parallel-group Pilot Trial|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
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 :
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)
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
Other Name: SEIRIN J-Type
No Intervention: Waiting list group
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.
- 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
- Cervical mobility on the Cervical ROM [ Time Frame: Change from Baseline in cervical ROM at 2 weeks (post treatment) ]Cervical ROM was measured in six directions (Flexion, Extension, Right lateral bending, Left lateral bending, Right rotation, Left rotation) with goniometer.
- 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) ]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)
- SDS (Zung Self Rating Depression Scale) [ Time Frame: Change from Baseline in SDS at 2 weeks (post treatment) ]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
- CMI (Cornell Medical Index) [ Time Frame: Change from Baseline in CMI at 2 weeks (post treatment) ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395511
|Korea, Republic of|
|Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center|
|Seoul, Hoegi-dong, Dongdaemun-gu, Seoul, Korea, Republic of, 130-702|
|Principal Investigator:||Do Young Choi, Professor||Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center.|