Whiplash Associated Disorder (WAD) Clinical Trial
Official title:
Acupuncture for Whiplash Associated Disorder: a Randomised, Waiting-list Controlled, Open-label, Parallel-group Pilot Trial
| Verified date | December 2009 |
| Source | Kyunghee University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | October 2010 |
| Est. primary completion date | October 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center | Seoul | Hoegi-dong, Dongdaemun-gu, Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Kyunghee University Medical Center | University of Tsukuba |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Change from Baseline in VAS at 2 weeks (post treatment) | Yes |
| Secondary | 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. | Change from Baseline in cervical ROM at 2 weeks (post treatment) | Yes |
| Secondary | 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) | Change from Baseline in SF-36 at 2 weeks (post treatment) | Yes |
| Secondary | 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 | Change from Baseline in SDS at 2 weeks (post treatment) | Yes |
| Secondary | 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 | Change from Baseline in CMI at 2 weeks (post treatment) | Yes |