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Clinical Research on the Efficacy of Acupuncture Treatment in Chronic Low Back Pain

Expanded access is currently available for this treatment.
Verified December 2008 by Kyunghee University Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00815529
First Posted: December 30, 2008
Last Update Posted: December 30, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Korea Health Industry Development Institute
Information provided by:
Kyunghee University Medical Center
  Purpose

This research is planned to build a basis about effect of acupuncture for chronic low back pain with economical efficacy.

It is consisted with two sub research. First,clinical research to know the effect of acupuncture for chronic low back pain will be processed with acclate, randomized, patient, outcome-assessor masking. 130 subjects would be collected and devided into two groups(Experimental and placebo). Experimental group will undergo with real acupunture treatment twice a week, for 6 weeks and acupuncture spots would be selected for each person by clinical specialist. Placebo group will undergo with Park-sham needle and same 8 acupuncture spots would be used for all subjects also twice a week, for 6 weeks. The effect will be accessed by VAS, x-ray, ODI, SF-36, EQ-5D, BDI before and the last treatments.

Second is qualitative research to make a basis through the economic evaluation and satisfaction of acupuncture treatment for chronic low back pain. 15 persons who have been treated at oriental medical hospital for chronic low back pain and 15 in experimental group and 15 in placebo group who participate the clinical research will be collected and through the personal interview, satisfaction about the treatment and economic efficacy will be evaluated.


Condition Intervention
Chronic Low Back Pain Acupuncture Device: Acupuncture, Pak-sham needle

Study Type: Expanded Access     What is Expanded Access?
Official Title: Clinical Research on the Efficacy of Acupuncture Treatment in Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Kyunghee University Medical Center:

Intervention Details:
    Device: Acupuncture, Pak-sham needle
    25*40mm, from 10 to 15 per each person, with the death from 5 to 20 mm, for from 15 to 20 minutes.
    Other Name: Dongbang Acupuncture Inc.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • The person who have been undergo chronic low back pain for chief complain over 3 months.
  • The person whose age is from 18 to 65.
  • The person who are normal in neurology examination.
  • The person whose bothersomeness for the last week before the participation of the treatment is over VAS 5.
  • The person who are diagnosed as nonspecific loe back pain.

Exclusion Criteria:

  • The person who have radicular pain.
  • The person who are diagnosed as specific disease which cause low back pain such as metastatic cancer, vertebral fracture, spinal infection, inflammatory spondylitis.
  • The person who are diagnosed as other chronic disease which could affect the result such as caediovascular disease, diabetic neurophaty, active hepatitis, fibromyalagia, rheumatic arthritis, dementia, hemorrhagic disease, epilepsy.
  • The person who have had or would have spinal surgery.
  • The person who have other skeletomuscular pain as chief complain.
  • The person who have been treated acupuncture treatment for low back pain last 1 month.
  • The person who is taking corticosteroids, narcotics, muscle relaxant,anticoagulant drug, herb-med for low back pain, or other non-propal drugs.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00815529


Contacts
Contact: Yoojung Cho 82-2-440-7577 aphrodite555@hanmail.net
Contact: Ara Lee 82-2-440-7575 ah810903@hotmail.com

Locations
Korea, Republic of
East West Neo Medical Center, Kyung-hee university
Seoul, Gangdong-Gu, Korea, Republic of, 134-727
Contact: yoojung cho    82-2-440-7577    aphrodite555@hanmail.net   
Contact: Ara Lee    82-2-440-7575    ah810903@hotmail.com   
Sponsors and Collaborators
Kyunghee University Medical Center
Korea Health Industry Development Institute
Investigators
Principal Investigator: Mi-yeon Song Kyunghee University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mi-yeon Song, KyungHee University
ClinicalTrials.gov Identifier: NCT00815529     History of Changes
Other Study ID Numbers: KyungHU
First Submitted: December 29, 2008
First Posted: December 30, 2008
Last Update Posted: December 30, 2008
Last Verified: December 2008

Keywords provided by Kyunghee University Medical Center:
Acupuncture
Chronic low back pain
Qualitative study

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms