NCT01314820

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
Last Updated

March 15, 2011

Status Verified

January 1, 2010

Enrollment Period

7 months

First QC Date

March 14, 2011

Last Update Submit

March 14, 2011

Conditions

Keywords

KneeOsteoarthritisEffusion.

Outcome Measures

Primary Outcomes (1)

  • the peak torque of the knee extensors

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

    within 5 minutes after intervention

Secondary Outcomes (1)

  • the root mean square values of the vastus medialis and vastus lateralis muscles

    within 5 minutes after intervention

Study Arms (2)

normal saline injection

ACTIVE COMPARATOR

20 cc normal saline injection into the knee joint

Other: normal saline injection

sham injection

SHAM COMPARATOR

knee injection without saline

Other: sham injection

Interventions

20 cc normal saline injection into knee joint

Also known as: normal saline
normal saline injection

no saline injection

Also known as: no normal saline
sham injection

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old or older with knee osteoarthritis
  • knee pain without joint effusion confirmed by ultrasonography

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, Seoul, 137-701, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 3403614BACKGROUND
  • 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.

    PMID: 3664162BACKGROUND
  • 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.

    PMID: 19116960BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Saline Solutionsalicylhydroxamic acid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Jongin Lee, M.D

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 15, 2011

Study Start

June 1, 2009

Primary Completion

January 1, 2010

Study Completion

June 1, 2010

Last Updated

March 15, 2011

Record last verified: 2010-01

Locations