Acupuncture for Whiplash Associated Disorder

NCT01395511 | Completed Phase 2

• 1 other identifier: KOMC MIRB2009-05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Whiplash Associated Disorder (WAD)

Keywords

whiplash associated disorder,; Intractable Traumatic Cervical Syndrome,; Acupuncture,; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cervical mobility on the Cervical ROM

  Change from Baseline in cervical ROM at 2 weeks (post treatment)

• Quality of life on the SF-36(36-Item Short-Form Health Survey)

  Change from Baseline in SF-36 at 2 weeks (post treatment)

• SDS (Zung Self Rating Depression Scale)

  Change from Baseline in SDS at 2 weeks (post treatment)

• CMI (Cornell Medical Index)

  Change from Baseline in CMI at 2 weeks (post treatment)

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Waiting list group

NO INTERVENTION

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.

Interventions

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

Also known as: SEIRIN J-Type

Acupuncture

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyunghee University Medical Center: lead
• University of Tsukuba: collaborator

Study Sites (1)

Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center

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

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Do Young Choi, Professor

  Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 15, 2011
• Study Start: December 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 15, 2011

Record last verified: 2009-12

Locations

KR (1)