Clinical trial NCT01395511: Acupuncture for Whiplash Associated Disorder
Official title: Acupuncture for Whiplash Associated Disorder: a Randomised, Waiting-list Controlled, Open-label, Parallel-group Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Whiplash Associated Disorder (WAD)
Keywords: whiplash associated disorder,
Intractable Traumatic Cervical Syndrome,
Acupuncture,
Randomized controlled trial
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Tsukuba
First posted: 2011-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. (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)

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Scores on the Visual Analog Scale
timeFrame: Change from Baseline in VAS at 2 weeks (post treatment)
Secondary outcomes:
measure: Cervical mobility on the Cervical ROM
timeFrame: Change from Baseline in cervical ROM at 2 weeks (post treatment)
measure: Quality of life on the SF-36(36-Item Short-Form Health Survey)
timeFrame: Change from Baseline in SF-36 at 2 weeks (post treatment)
measure: SDS (Zung Self Rating Depression Scale)
timeFrame: Change from Baseline in SDS at 2 weeks (post treatment)
measure: CMI (Cornell Medical Index)
timeFrame: Change from Baseline in CMI at 2 weeks (post treatment)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center
state: Hoegi-dong, Dongdaemun-gu, Seoul
Study officials:
affiliation: Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center.
name: Do Young Choi, Professor
role: PRINCIPAL_INVESTIGATOR
References: