Acupuncture for Whiplash Associated Disorder

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

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.

Study Overview

• Status: Completed
• Conditions: Whiplash Associated Disorder (WAD)
• Intervention / Treatment: Device: Acupuncture

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: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Hoegi-dong, Dongdaemun-gu, Seoul
    • Seoul, Hoegi-dong, Dongdaemun-gu, Seoul, Korea, Republic of, 130-702
      • Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from Baseline in VAS at 2 weeks (post treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Baseline in cervical ROM at 2 weeks (post treatment)
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)	Change from Baseline in SF-36 at 2 weeks (post treatment)
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	Change from Baseline in SDS at 2 weeks (post treatment)
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	Change from Baseline in CMI at 2 weeks (post treatment)

Collaborators and Investigators

• Sponsor: Kyunghee University Medical Center
• Collaborators: University of Tsukuba
• Investigators: Principal Investigator: Do Young Choi, Professor, Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: July 14, 2011
• First Submitted That Met QC Criteria: July 14, 2011
• First Posted (Estimate): July 15, 2011

Study Record Updates

• Last Update Posted (Estimate): July 15, 2011
• Last Update Submitted That Met QC Criteria: July 14, 2011
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Randomized controlled trial; whiplash associated disorder,; Intractable Traumatic Cervical Syndrome,; Acupuncture,
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Neck Injuries; Disease; Whiplash Injuries
• Other Study ID Numbers: KOMC MIRB2009-05