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Acupuncture for Whiplash Associated Disorder

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ClinicalTrials.gov Identifier: NCT01395511
Recruitment Status : Completed
First Posted : July 15, 2011
Last Update Posted : July 15, 2011
Sponsor:
Collaborator:
University of Tsukuba
Information provided by:
Kyunghee University Medical Center

Tracking Information
First Submitted Date  ICMJE July 14, 2011
First Posted Date  ICMJE July 15, 2011
Last Update Posted Date July 15, 2011
Study Start Date  ICMJE December 2009
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2011)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture for Whiplash Associated Disorder
Official Title  ICMJE Acupuncture for Whiplash Associated Disorder: a Randomised, Waiting-list Controlled, Open-label, Parallel-group Pilot Trial
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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Whiplash Associated Disorder (WAD)
Intervention  ICMJE Device: Acupuncture

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
Study Arms  ICMJE
  • Experimental: Acupuncture

    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)

    Intervention: Device: Acupuncture
  • 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.

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2011)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01395511
Other Study ID Numbers  ICMJE KOMC MIRB2009-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Do-Young Choi, Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center
Study Sponsor  ICMJE Kyunghee University Medical Center
Collaborators  ICMJE University of Tsukuba
Investigators  ICMJE
Principal Investigator: Do Young Choi, Professor Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center.
PRS Account Kyunghee University Medical Center
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP