Clinical Observation and MRI Influence of Acupuncture on Knee Osteoarthritis
Primary Purpose
Knee Arthritis Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acupuncture
physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Knee Arthritis Osteoarthritis focused on measuring Osteoarthritis, MRI, Cartilage, Acupuncture
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
acupuncture group
physiotherapy group
Arm Description
Acupuncture treatment was given once every other day and 20min each time for four weeks.
Physiotherapy treatment was given five times a week and 30min each time for four weeks.
Outcomes
Primary Outcome Measures
WOMAC scores
T2 Values
Secondary Outcome Measures
Full Information
NCT ID
NCT02446756
First Posted
May 6, 2015
Last Updated
May 13, 2015
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02446756
Brief Title
Clinical Observation and MRI Influence of Acupuncture on Knee Osteoarthritis
Official Title
Clinical Observation and MRI Influence of Acupuncture on Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthritis Osteoarthritis
Keywords
Osteoarthritis, MRI, Cartilage, Acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
acupuncture group
Arm Type
Experimental
Arm Description
Acupuncture treatment was given once every other day and 20min each time for four weeks.
Arm Title
physiotherapy group
Arm Type
Active Comparator
Arm Description
Physiotherapy treatment was given five times a week and 30min each time for four weeks.
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Type
Other
Intervention Name(s)
physiotherapy
Primary Outcome Measure Information:
Title
WOMAC scores
Time Frame
up to 24 months
Title
T2 Values
Time Frame
up to 30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Clinical Observation and MRI Influence of Acupuncture on Knee Osteoarthritis
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