Acupuncture for Whiplash Associated Disorder

NCT ID: NCT01395511

Last Updated: 2011-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-10-31

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)

Conditions

Whiplash Associated Disorder (WAD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: 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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

SEIRIN J-Type

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tsukuba

OTHER

Sponsor Role: collaborator

Kyunghee University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center

Principal Investigators

Do Young Choi, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center.

Locations

Department of Acupuncture & Moxibustion, Kyunghee Oriental Medical Center

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

Countries

South Korea

Other Identifiers

KOMC MIRB2009-05

Identifier Type: -

Identifier Source: org_study_id