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Effects of Joint Effusion on Quadriceps Muscle

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
normal saline injection
sham injection
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Knee Osteoarthritis focused on measuring Knee, Osteoarthritis, Effusion.

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

normal saline injection

sham injection

Arm Description

20 cc normal saline injection into the knee joint

knee injection without saline

Outcomes

Primary Outcome Measures

the peak torque of the knee extensors
to evaluate the effect of effusion on the peak torque of the knee extensors

Secondary Outcome Measures

the root mean square values of the vastus medialis and vastus lateralis muscles
to evaluate the effect of effusion on the RMS of the vastus medialis (VM) and vastus lateralis (VL) muscles

Full Information

First Posted
March 14, 2011
Last Updated
March 14, 2011
Sponsor
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01314820
Brief Title
Effects of Joint Effusion on Quadriceps Muscle
Official Title
Effects of Joint Effusion on Quadriceps Muscle in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Catholic University of Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee, Osteoarthritis, Effusion.

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
normal saline injection
Arm Type
Active Comparator
Arm Description
20 cc normal saline injection into the knee joint
Arm Title
sham injection
Arm Type
Sham Comparator
Arm Description
knee injection without saline
Intervention Type
Other
Intervention Name(s)
normal saline injection
Other Intervention Name(s)
normal saline
Intervention Description
20 cc normal saline injection into knee joint
Intervention Type
Other
Intervention Name(s)
sham injection
Other Intervention Name(s)
no normal saline
Intervention Description
no saline injection
Primary Outcome Measure Information:
Title
the peak torque of the knee extensors
Description
to evaluate the effect of effusion on the peak torque of the knee extensors
Time Frame
within 5 minutes after intervention
Secondary Outcome Measure Information:
Title
the root mean square values of the vastus medialis and vastus lateralis muscles
Description
to evaluate the effect of effusion on the RMS of the vastus medialis (VM) and vastus lateralis (VL) muscles
Time Frame
within 5 minutes after intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jongin Lee, M.D
Organizational Affiliation
Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Official's Role
Study Director
Facility Information:
Facility Name
Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
3403614
Citation
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.
Results Reference
background
PubMed Identifier
3664162
Citation
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.
Results Reference
background
PubMed Identifier
19116960
Citation
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.
Results Reference
background

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Effects of Joint Effusion on Quadriceps Muscle

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