- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01060215
The Effects of Joint Effusion on Proprioception
Clinical Trial for the Effects of Joint Effusion on Proprioception
Study Overview
Detailed Description
Proprioception is a sensory modality that provides feedback on the internal status of the body and enables us to perceive joint position and motion.
Osteoarthritis (OA), also called degenerative joint disease, is a major musculoskeletal condition characterized by loss of articular cartilage that leads to pain and loss of function. The most commonly affected joint is the knee, and OA may result in changes that affect not only intracapsular tissues, but also periarticular tissues, such as ligaments, capsules, tendons, and muscles. Many studies have examined the proprioceptive status of knee OA, and subjects with knee OA are known to have impaired proprioception compared with age-matched controls.
Joint effusion is a common symptom associated with chronic degenerative joint condition, but the effects of effusion on knee joint proprioception have not been investigated in detail.
A volume of 20 mL of normal saline was injected into the knee joint cavity of subjects in the experimental group under ultrasonographic guidance. Proprioceptive acuity was assessed by active repositioning of the lower limb using an electrogoniometer to measure knee joint position sense (JPS) under both non-weight-bearing and weight-bearing conditions twice, with a 20-min rest interval.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Seoul, Korea, Republic of, 137-701
- Seoul St. Mary's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Infusion
20cc saline infusion into the knee joint
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20 cc normal saline injection into the knee joint
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No Intervention: No infusion
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20 cc normal saline injection into the knee joint
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
Time Frame: within one hour after intervention
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within one hour after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jongin Lee, M.D, Department of Rehabilitation Medicine, Seoul St. Mary's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 52008B000100044
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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