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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Kyunghee University Medical Center.
Recruitment status was  Available
Sponsor:
Collaborator:
Korea Health Industry Development Institute
Information provided by:
Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT00815529
First received: December 29, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Kyung Hee University
  More Information

No publications provided by Kyunghee University Medical Center

Additional 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
Study First Received: December 29, 2008
Last Updated: December 29, 2008
Health Authority: South Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013