|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00325663 |
|
Date of registration:
|
12/05/2006 |
|
Primary sponsor: |
|
|
Public title:
|
Acupuncture in Osteoarthritis of the Knee
|
|
Scientific title:
|
Specific and Non-Specific Effects of Acupuncture: A Double-Blinded, Randomized, Controlled Trial in Patients With Osteoarthritis of the Knee |
|
Date of first enrolment:
|
April 2004 |
|
Target sample size:
|
125 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00325663 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
|
|
Contacts
|
|
Name:
|
Frank Brazkiewicz, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Centre for Chinese Medicine, Bremen, Germany |
|
|
Name:
|
Johannes Greten, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
German Society of Traditional Chinese Medicine |
|
|
Name:
|
Oliver Gerlach, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Shen-Centre for Traditional Chinese Medicine, Erlangen, Germany |
|
|
Name:
|
Max Karner, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University Heidelberg |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients above age 35
- knee osteoarthritis grade II or III according to the Kellgren classification.
Exclusion Criteria:
- orthopedic deformations of the knee,
- malignant disease
- auto-immune disorders
- surgery including arthroscopy during the past 12 months
- pain medication with steroids
- physical therapy or acupuncture within the last for weeks
- no or a pain medication in continuous dosage
Age minimum:
35 Years
Age maximum:
90 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Osteoarthritis of the Knee
|
|
Intervention(s)
|
|
Procedure: Acupuncture
|
|
Primary Outcome(s)
|
|
Main outcome measures: Improvement in knee flexibility according to the neutral-zero method, defining a success as improvement by 10 degrees or more.
|
|
Secondary Outcome(s)
|
|
Secondary parameter: improvement in pain according to the reduced WOMAC score by 50 percent or more.
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|