Acupuncture for Whiplash Associated Disorder

This study has been completed.
Sponsor:
Collaborator:
University of Tsukuba
Information provided by:
Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01395511
First received: July 14, 2011
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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 Intervention Phase
Whiplash Associated Disorder (WAD)
Device: Acupuncture
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acupuncture for Whiplash Associated Disorder: a Randomised, Waiting-list Controlled, Open-label, Parallel-group Pilot Trial

Resource links provided by NLM:


Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • Pain Scores on the Visual Analog Scale [ Time Frame: Change from Baseline in VAS at 2 weeks (post treatment) ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Cervical mobility on the Cervical ROM [ Time Frame: Change from Baseline in cervical ROM at 2 weeks (post treatment) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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


Enrollment: 40
Study Start Date: December 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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
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.


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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395511

Locations
Korea, Republic of
Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center
Seoul, Hoegi-dong, Dongdaemun-gu, Seoul, Korea, Republic of, 130-702
Sponsors and Collaborators
Kyunghee University Medical Center
University of Tsukuba
Investigators
Principal Investigator: Do Young Choi, Professor Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center.
  More Information

No publications provided

Responsible Party: Do-Young Choi, Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center
ClinicalTrials.gov Identifier: NCT01395511     History of Changes
Other Study ID Numbers: KOMC MIRB2009-05
Study First Received: July 14, 2011
Last Updated: July 14, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Kyunghee University Medical Center:
whiplash associated disorder,
Intractable Traumatic Cervical Syndrome,
Acupuncture,
Randomized controlled trial

Additional relevant MeSH terms:
Whiplash Injuries
Neck Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on August 20, 2014