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Completed

NCT Number: NCT01395511

Acupuncture for Whiplash Associated Disorder

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.

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Key information

Conditions

Whiplash Associated Disorder (WAD)

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center

Seoul, Hoegi-dong, Dongdaemun-gu, Seoul, 130-702, South Korea

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acupuncture

Device

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 names: SEIRIN J-Type

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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)

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Collaborators

  • University of Tsukuba

Registry information

Official study title

Acupuncture for Whiplash Associated Disorder: a Randomised, Waiting-list Controlled, Open-label, Parallel-group Pilot Trial

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 15, 2011
Registry last updated
Jul 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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