- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01314820
Effects of Joint Effusion on Quadriceps Muscle
March 14, 2011 updated by: The Catholic University of Korea
Effects of Joint Effusion on Quadriceps Muscle in Patients With Knee Osteoarthritis
The present study investigated whether the presence of fluid in the joint affected peak torque and the root mean square (RMS) values of surface electromyography (EMG) in patients symptomatic for osteoarthritis (OA).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Several studies have shown that knee effusion influenced quadriceps muscle activity and induced quadriceps arthrogenic muscle inhibition in normal volunteers.
However, the effect of joint effusion on the quadriceps of patients with OA is controversial,and few patients with OA have been included in studies of joint effusion.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 137-701
- Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
-
-
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
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 50 years old or older with knee osteoarthritis
- knee pain without joint effusion confirmed by ultrasonography
Exclusion Criteria:
- the presence of knee joint effusion determined using US
- a history of knee injury or surgery
- a history of knee injection within 3 months
- a history of inflammatory arthritis
- taking anticoagulants
- balance or gait disturbance
- diabetes mellitus
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: normal saline injection
20 cc normal saline injection into the knee joint
|
20 cc normal saline injection into knee joint
Other Names:
|
Sham Comparator: sham injection
knee injection without saline
|
no saline injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the peak torque of the knee extensors
Time Frame: within 5 minutes after intervention
|
to evaluate the effect of effusion on the peak torque of the knee extensors
|
within 5 minutes after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the root mean square values of the vastus medialis and vastus lateralis muscles
Time Frame: within 5 minutes after intervention
|
to evaluate the effect of effusion on the RMS of the vastus medialis (VM) and vastus lateralis (VL) muscles
|
within 5 minutes after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jongin Lee, M.D, Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Fahrer H, Rentsch HU, Gerber NJ, Beyeler C, Hess CW, Grunig B. Knee effusion and reflex inhibition of the quadriceps. A bar to effective retraining. J Bone Joint Surg Br. 1988 Aug;70(4):635-8. doi: 10.1302/0301-620X.70B4.3403614.
- Jones DW, Jones DA, Newham DJ. Chronic knee effusion and aspiration: the effect on quadriceps inhibition. Br J Rheumatol. 1987 Oct;26(5):370-4. doi: 10.1093/rheumatology/26.5.370.
- Rice D, McNair PJ, Dalbeth N. Effects of cryotherapy on arthrogenic muscle inhibition using an experimental model of knee swelling. Arthritis Rheum. 2009 Jan 15;61(1):78-83. doi: 10.1002/art.24168.
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
June 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
March 14, 2011
First Submitted That Met QC Criteria
March 14, 2011
First Posted (Estimate)
March 15, 2011
Study Record Updates
Last Update Posted (Estimate)
March 15, 2011
Last Update Submitted That Met QC Criteria
March 14, 2011
Last Verified
January 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KC09OISI0161
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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