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Acupuncture for Whiplash Associated Disorder

Primary Purpose

Whiplash Associated Disorder (WAD)

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Whiplash Associated Disorder (WAD) focused on measuring whiplash associated disorder,, Intractable Traumatic Cervical Syndrome,, Acupuncture,, Randomized controlled trial

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupuncture

Waiting list group

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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)
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
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

Full Information

First Posted
July 14, 2011
Last Updated
July 14, 2011
Sponsor
Kyunghee University Medical Center
Collaborators
University of Tsukuba
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1. Study Identification

Unique Protocol Identification Number
NCT01395511
Brief Title
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

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kyunghee University Medical Center
Collaborators
University of Tsukuba

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash Associated Disorder (WAD)
Keywords
whiplash associated disorder,, Intractable Traumatic Cervical Syndrome,, Acupuncture,, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
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)
Arm Title
Waiting list group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Other Intervention Name(s)
SEIRIN J-Type
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain Scores on the Visual Analog Scale
Description
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
Time Frame
Change from Baseline in VAS at 2 weeks (post treatment)
Secondary Outcome Measure Information:
Title
Cervical mobility on the Cervical ROM
Description
Cervical ROM was measured in six directions (Flexion, Extension, Right lateral bending, Left lateral bending, Right rotation, Left rotation) with goniometer.
Time Frame
Change from Baseline in cervical ROM at 2 weeks (post treatment)
Title
Quality of life on the SF-36(36-Item Short-Form Health Survey)
Description
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)
Time Frame
Change from Baseline in SF-36 at 2 weeks (post treatment)
Title
SDS (Zung Self Rating Depression Scale)
Description
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
Time Frame
Change from Baseline in SDS at 2 weeks (post treatment)
Title
CMI (Cornell Medical Index)
Description
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
Time Frame
Change from Baseline in CMI at 2 weeks (post treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Do Young Choi, Professor
Organizational Affiliation
Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center
City
Seoul
State/Province
Hoegi-dong, Dongdaemun-gu, Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of

12. IPD Sharing Statement

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Acupuncture for Whiplash Associated Disorder

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