- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02446756
Clinical Observation and MRI Influence of Acupuncture on Knee Osteoarthritis
May 13, 2015 updated by: Peking Union Medical College Hospital
To observe the therapeutic effect of acupuncture on osteoarthritis(OA) and its efficacy on cartilage restoration,acupuncture and physiotherapy treatment were respectively given to two random groups.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to evaluate the motor function of knee joints, followed by magnetic resonance imaging (MRI) scanning to measure T2 values in ten cartilage sub-regions in tibiofemoral joints.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To observe the therapeutic effect of acupuncture on osteoarthritis and its efficacy on cartilage restoration,one hundred knees of 50 patients with knee osteoarthritis were randomly divided into acupuncture group and physiotherapy group which were respectively received acupuncture and physiotherapy treatment for four weeks.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to evaluate the motor function of knee joints, followed by magnetic resonance imaging (MRI) scanning to measure T2 values in ten cartilage sub-regions in tibiofemoral joints.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinically diagnosed as knee osteoarthritis according to the OA criteria proposed by American College of Rheumatology in 1995.
Exclusion Criteria:
- Acute knee injury
- Had ever accepted therapy as hormone or injection in articulation cavity
- Had ever accepted treatment as oral medicine, physiotherapy, acupuncture or massage during the passed three months
- Had planted cardiac pacemaker or any metal matter in body
- Other severe diseases such as heart, lung, liver, kidney or cerebrum failure, tumors, gastrointestinal hemorrhage and so on
- Pregnant or lactating woman
- Anyone unable to tolerate or cooperate with treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: acupuncture group
Acupuncture treatment was given once every other day and 20min each time for four weeks.
|
|
|
Active Comparator: physiotherapy group
Physiotherapy treatment was given five times a week and 30min each time for four weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
WOMAC scores
Time Frame: up to 24 months
|
up to 24 months
|
|
T2 Values
Time Frame: up to 30 months
|
up to 30 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
May 6, 2015
First Submitted That Met QC Criteria
May 13, 2015
First Posted (Estimate)
May 18, 2015
Study Record Updates
Last Update Posted (Estimate)
May 18, 2015
Last Update Submitted That Met QC Criteria
May 13, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PUMCH20150430
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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