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

Primary Purpose

Chronic Low Back Pain, Acupuncture

Status
Available
Phase
Locations
Korea, Republic of
Study Type
Expanded Access
Intervention
Acupuncture, Pak-sham needle
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Chronic Low Back Pain focused on measuring Acupuncture, Chronic low back pain, Qualitative study

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • East West Neo Medical Center, Kyung-hee university

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 29, 2008
Last Updated
December 29, 2008
Sponsor
Kyunghee University Medical Center
Collaborators
Korea Health Industry Development Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00815529
Brief Title
Clinical Research on the Efficacy of Acupuncture Treatment in Chronic Low Back Pain
Official Title
Clinical Research on the Efficacy of Acupuncture Treatment in Chronic Low Back Pain
Study Type
Expanded Access

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
Kyunghee University Medical Center
Collaborators
Korea Health Industry Development Institute

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Acupuncture
Keywords
Acupuncture, Chronic low back pain, Qualitative study

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Acupuncture, Pak-sham needle
Other Intervention Name(s)
Dongbang Acupuncture Inc.
Intervention Description
25*40mm, from 10 to 15 per each person, with the death from 5 to 20 mm, for from 15 to 20 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoojung Cho
Phone
82-2-440-7577
Email
aphrodite555@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
Ara Lee
Phone
82-2-440-7575
Email
ah810903@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mi-yeon Song
Organizational Affiliation
Kyunghee University
Official's Role
Principal Investigator
Facility Information:
Facility Name
East West Neo Medical Center, Kyung-hee university
City
Seoul
State/Province
Gangdong-Gu
ZIP/Postal Code
134-727
Country
Korea, Republic of
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yoojung cho
Phone
82-2-440-7577
Email
aphrodite555@hanmail.net
First Name & Middle Initial & Last Name & Degree
Ara Lee
Phone
82-2-440-7575
Email
ah810903@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
20540806
Citation
Lee JH, Park HJ, Lee H, Shin IH, Song MY. Acupuncture for chronic low back pain: protocol for a multicenter, randomized, sham-controlled trial. BMC Musculoskelet Disord. 2010 Jun 14;11:118. doi: 10.1186/1471-2474-11-118.
Results Reference
derived

Learn more about this trial

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

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