NCT01060215

Brief Summary

The purpose of this study is to assess the effects of joint effusion on proprioceptive status in patients with knee 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

Timeline
Completed

Started May 2009

Shorter than P25 for not_applicable

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

May 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
Last Updated

February 2, 2010

Status Verified

January 1, 2010

Enrollment Period

8 months

First QC Date

January 28, 2010

Last Update Submit

February 1, 2010

Conditions

Keywords

effusionosteoarthritisknee

Outcome Measures

Primary Outcomes (1)

  • Proprioceptive acuity in Knee Joint. Proprioceptive acuity (difference between the knee angles at the target and reproduced positions) was assessed by active repositioning of the lower limb after injection or no injection.

    within one hour after intervention

Study Arms (2)

Infusion

ACTIVE COMPARATOR

20cc saline infusion into the knee joint

Procedure: Normal saline

No infusion

NO INTERVENTION
Procedure: Normal saline

Interventions

Normal salinePROCEDURE

20 cc normal saline injection into the knee joint

InfusionNo infusion

Eligibility Criteria

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

You may qualify if:

  • Or at least two of criteria 2-6 established by the American College of Rheumatology (ACR):
  • Kellgren and Lawrence (K/L) grade ≥II
  • morning stiffness \<30 min in duration
  • crepitus on movement of the knee joint
  • bony tenderness at the knee joint margins
  • palpable or visible bony enlargement
  • no palpable warmth.

You may not qualify if:

  • the presence of knee joint effusion determined by ultrasonography
  • 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)

Seoul St. Mary's Hospital

Seoul, Seoul, 137-701, South Korea

Location

Related Publications (1)

  • Cho YR, Hong BY, Lim SH, Kim HW, Ko YJ, Im SA, Lee JI. Effects of joint effusion on proprioception in patients with knee osteoarthritis: a single-blind, randomized controlled clinical trial. Osteoarthritis Cartilage. 2011 Jan;19(1):22-8. doi: 10.1016/j.joca.2010.10.013. Epub 2010 Oct 27.

MeSH Terms

Conditions

Osteoarthritis

Interventions

Saline Solution

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

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 28, 2010

First Posted

February 2, 2010

Study Start

May 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 2, 2010

Record last verified: 2010-01

Locations