OsteoarthritisNCT01060215
The Effects of Joint Effusion on Proprioception
A study testing Normal saline in people with Osteoarthritis, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to assess the effects of joint effusion on proprioceptive status in patients with knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Normal saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial for the Effects of Joint Effusion on Proprioception
The purpose of this study is to assess the effects of joint effusion on proprioceptive status in patients with knee osteoarthritis (OA).
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Normal saline
- Keywords
- effusion, osteoarthritis, knee
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineProcedure or surgery
20 cc normal saline injection into the knee joint
| Study group | Role | What they receive |
|---|---|---|
| Infusion | Active comparator | 20cc saline infusion into the knee joint Receives: Procedure: Normal saline |
| No infusion | No intervention | Not described Receives: Procedure: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within one hour after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startMay 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Investigators
- Jongin Lee, M.D, Study chair, Department of Rehabilitation Medicine, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060215
- Sponsor's protocol ID
- 52008B000100044
- Status last verified
- Jan 2010
- First submitted
- 28 Jan 2010
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21034839
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Effects of Joint Effusion on Proprioception
- ClinicalTrials.gov ID
- NCT01060215
- Acronym / sponsor ID
- 52008B000100044
- Conditions
- Osteoarthritis
- Keywords
- effusion, osteoarthritis, knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 2 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effects of joint effusion on proprioceptive status in patients with knee osteoarthritis (OA).
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infusion | Active comparator | Procedure: Normal saline20cc saline infusion into the knee joint |
| No infusion | No intervention | Procedure: Normal saline |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal saline20 cc normal saline injection into the knee joint | Procedure or surgery | Infusion, No infusion |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
- Derived from this study: PubMed 21034839Cho 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jongin Lee, M.D study chair
Department of Rehabilitation Medicine, Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline in people with Osteoarthritis, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01060215, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2010.