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Clinical Trial 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.


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01395511
Study type Interventional
Source Kyunghee University Medical Center
Contact
Status Completed
Phase Phase 2
Start date December 2009
Completion date October 2010